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Scientific Poster Abstracts Selected for the 2017 Congress on Cardiovascular Disease Prevention, Sept. 15–17, 2017, Fort Lauderdale, Florida
2017 Abstracts Committee: Wilbert Aronow, MD; Amit Khera, MD; Stephen Kopecky, MD; Douglas D. Schocken, MD; Laurence S. Sperling, MD (Chair); James A. Underberg, MD
The American Society for Preventive Cardiology (ASPC) is pleased to announce that 29 abstracts were accepted for presentation in the poster format for the 2016 Congress on Atherosclerotic Cardiovascular Disease Prevention taking place Sept. 15–17, 2017, Fort Lauderdale, FL. Each abstract was reviewed by the ASPC Abstracts Committee prior to acceptance. Thanks to all of the authors who submitted abstracts for this year's poster hall.
2017 Young Investigators
ASPC would like to congratulate the outstanding winners of the 2017 Young Investigator Competition, whose entries were judged on the quality, clarity of science, and interest to the field of preventive cardiology.
1st Place: Anurag Mehta, MD: Validation of the ACC/AHA Pooled Cohort Equations for Cardiovascular Risk Assessment: A Meta‐Analysis. Abstract ID: 106
2nd Place: Alina Brener, MD: Characteristics Associated with Weight Gain in the Dallas Heart Study. Abstract ID: 120
3rd Place: Anna Svatikova, MD, PhD: Hyperinsulinemic Response to Energy Drink Intake in Healthy Adults: A Randomized, Double Blind, Placebo Controlled Clinical Trial. Abstract ID: 104
Note: Young Investigator abstract titles are marked with an asterisk.* Encore abstracts are marked with a dagger symbol.†
The views and opinions expressed in the abstracts are those of the authors and do not necessarily reflect the views and opinions of the American Society for Preventive Cardiology and Clinical Cardiology. Abstracts appearing here may contain statements, opinions, and information that have errors in facts, figures, or interpretation. Accordingly, the American Society for Preventive Cardiology, Clinical Cardiology, and its editors are not responsible or liable for the use of any such inaccurate or misleading data, opinion, or information contained in the abstracts
100: STRESS MANAGEMENT AND RESILIENCE INTERVENTION IN A WOMEN'S HEART CLINIC: A PILOT CLINICAL TRIAL STUDY*
Jose Medina‐Inojosa, Mariana Garcia, Sharon Mulvagh, Saswati Mahapatra, Francisco Lopez‐Jimenez, Brent Brauer, Stephen Cha, Amit Sood, and Anjali Bhagra
Abstract Topic
Alternative and Complementary Approaches
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Women experience significantly higher stress levels than men. High baseline anxiety, depression, and stress levels are associated with greater risk of cardiovascular diseases (CVD). Current evidence for efficacy of stress management interventions for women is limited.
Objective/Purpose
The present study aimed to assess the effect of a stress management and resiliency training (SMART) program for decreasing stress, anxiety, and depressive symptoms.
Methods
Fifty Women'S Heart/Preventive Cardiology Clinic patients consented to SMART intervention delivered online (n=36) or in‐person (n=9). Primary outcome measures were the observed changes between baseline and 12 weeks for the following psychometrics: general anxiety disorder‐7 (GAD‐7), patient health questionnaires (PHQ‐9), perceived stress scale (PSS), and brief resiliency scale (BRS).
Results
Forty five patients completed the study. Statistically significant improvements in PSS and GAD‐7, but not PHQ‐9 or BRS, were observed after the SMART intervention. When assessing outcomes among those with depressive symptoms at baseline (PHQ‐9>15), we observed changes in PSS and GAD‐7, and PHQ‐9. No differences between online or in‐person program delivery methods were observed (all p‐values > 0.05).
Conclusions
A single exposure using the SMART program to decrease and manage stress and anxiety in women seeking preventive cardiology services was feasible and similarly effective, whether delivered online or in‐person. Impact on depression and resilience likely require a more intensive approach. In the future, larger randomized clinical trials with additional methods and longer follow‐up are warranted.
101: LIPOPROTEIN X DISEASE IN THE SETTING OF SEVERE CHOLESTATIC HEPATOBILIARY AUTOIMMUNE DISEASE*
Robert Heinl, Patrick Moriarty, Laurence Sperling, Heather Tennant, and John Ricketts
Abstract Topic
ASCVD in Special Populations
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Few conditions are associated with a total cholesterol above 1000 mg/dL. Lipoprotein‐X (LP‐X) Disease causes critically‐elevated lipids.
Objective/Purpose
Three cases are presented. First line apheresis modalities, pathophysiology, and mechanisms/lipid structure are reviewed.
Methods
N/A
Results
Case 1: A 33‐year‐old male with ulcerative colitis presented with hepatic failure secondary to primary sclerosing cholangitis. LDL‐C was 360 mg/dL with an LDL particle concentration of 3,816 nmol/L in the absence of cardiac or family history. The combination of both rapid hepatic failure and the above studies led to LP‐X as the diagnosis. Orthotopic liver transplantation (OLT) was received prior to undergoing recommended Heparin‐mediated Extra‐corporeal LDL Precipitation (HELP) apheresis. Post‐transplant lab levels were within normal ranges. Case 2: A 55‐year‐old female with hyperlipidemia and OLT 13 years prior presented with fatigue and jaundice. Liver biopsy revealed microvesicular steatosis with chronic rejection. Admission labs included a serum glucose of 800 mg/dL, alkaline phosphatase (ALP) of 2,697 U/L, total bilirubin of 14.4 μmol/L, and a triglyceride level of 3,474 mg/dL. LDL‐C was unmeasureable. Two sessions of dextran sulfate adsorption (DSA) LDL‐apheresis did not improve lipid profile. History of OLT, cholestasis, and marked hyperlipidemia supported LP‐X as a diagnosis of exclusion. Case 3: A 52‐year‐old male with hyperlipidemia presented with end stage liver and kidney disease. Liver failure was secondary to chronic Hepatitis B, and renal failure resulted from diabetic nephropathy. MELD score was 36 while listed for combined liver/kidney transplantation. Pre‐transplantation labs included a serum creatinine of 3.8 μmol/L, AST of 6,166 U/L, and ALP of 1,086 U/L. Total cholesterol was 1,155 mg/dL and LDL‐C was 1,364 mg/dL. The patient received HELP‐LDL‐apheresis. LP‐X was diagnosed after cholesterol and LDL‐C levels improved subsequent to OLT.
Conclusions
LP‐X is a carrier of cholesterol in the same density range as LDL. First line therapies for LP‐X include apheresis and plasma exchange. Regurgitant bile lipoprotein from cholestasis leads to increased formation of LP‐X. OLT ultimately resolves hyperlipidemia. Overt clinical coronary artery disease has not been documented in any of these three patients. LP‐X reduces LDL atherogenicity and anti‐oxidative properties.
102: CORRELATION OF LIVER ADIPOSITY WITH CHRONIC INFLAMMATION AND CORONARY PLAQUE: A STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS*
Panteha Rezaeian, Aryabod Razipour, Dong Li, George Karpouzas, and Matthew Budoff
Abstract Topic
ASCVD in Special Populations
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Inflammation, oxidative stress, and hyperlipidemia underline the association of liver adiposity (liver steatosis) with cardiovascular disease (CVD). Rheumatoid arthritis (RA) is characterized by high inflammatory burden leading to bone and cartilage destruction as well as greater cardiovascular morbidity and mortality compared to controls.
Objective/Purpose
We explored the relationships between disease activity, liver adiposity, and quantitative and qualitative coronary plaque characteristics in subjects with RA.
Methods
One hundred and fifty patients without symptoms or diagnosis of CVD were evaluated with 64‐slice CTA. The following were collected: cardiac risk factors, serologies including rheumatoid factor (RF) and anti‐citrullinated peptide antibodies (ACPA), inflammatory and lipid‐markers including erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP), and interleukin‐6. RA activity was assessed as disease activity score out of 28 joints (DAS28‐CRP). Segment involvement score (SIS), degree of segment stenosis (stenosis severity score‐ SSS), total plaque score (TPS), and composition were evaluated with a 15 segment standardized American Heart Association model. Plaques were classified as non‐calcified (NCP), mixed (MP), and fully calcified (CP). Liver attenuation was measured in two separate regions of interest with uniform attenuation and spanning >100mm2. Hepatic attenuation <40 Hounsfield Units (HU) was used as a cutoff of >30% liver fat content and defined as a liver adiposity. The mean of two values was used.
Results
Twenty‐three of 150 (15%) subjects had liver adiposity and disease activity was significantly higher in those compared to subjects without it (DAS28‐CRP=3.1±1.0 vs. 2.5±1.0, p=0.01). Higher DAS28‐CRP was associated with significantly lower liver attenuation after adjustments for age, gender, all cardiac risk factors, lipids, and statin therapy (p=0.03). However, quantitative coronary plaque measurements did not show significant association with liver adiposity.
Conclusions
Disease activity in RA is independently associated with higher prevalence of liver adiposity. However, no direct association of liver adiposity with quantitative plaque measurements was observed.
103: ULTRA‐SENSITIVE CARDIAC TROPONIN‐I (US‐CTNI) INVERSELY CORRELATES WITH BONE MINERAL DENSITY IN PATIENTS WITH RHEUMATOID ARTHRITIS: USING MULTI‐SLICE COMPUTED TOMOGRAPHY*†
Panteha Rezaeian, Aryabod Razipour, Joel Estis, Mohammed Zaveri, John Todd, Matthew Budoff, and George Karpouzas
Abstract Topic
ASCVD in Special Populations
Lead Author'S Financial Disclosures
None
Study Funding
A grant was received from the American Heart Association.
Background/Synopsis
Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by articular destruction as well as local and generalized bone loss. Furthermore, RA patients experience accelerated cardiovascular morbidity and mortality. Blood concentrations of cardiac troponin‐I (cTnI), a biomarker of myocardial injury, are known to be elevated in patients with RA.
Objective/Purpose
To explore the association of ultra‐sensitive Cardiac Troponin‐I (us‐CTnI) with bone mineral density (BMD) in patients with RA and investigate the association of us‐cTnI and coronary artery calcification (CAC) in the RA subjects with low BMD.
Methods
A cohort of 136 RA subjects (median age 54 years, 87% female) was evaluated. Non‐enhanced computed tomography (CT) was used to measure the patients' CAC score and bone BMD. CAC was reported as Agatston's score using smart‐score software by Adw4.6 GE workstation. BMD was evaluated on axial and sagittal images of three consecutive vertebrae starting at the level of the left main artery origin using Adw4.6 GE workstation density analysis software. The average of six values was used as the final measurement. Ultrasensitive cardiac Troponin‐I (us‐cTnI) was quantified with the Erenna® System (Research Use Only, Singulex Inc., Alameda, CA) using plasma collected at the time of CT.
Results
A significant, inverse association was revealed between us‐cTnI and BMD. The results remained significant after adjustments for age, gender, BMI, calcium, and vitamin D administration. A one unit log‐transformed us‐cTnI increase predicted a 11.1 Hounsfield unit (HU) decrease in BMD after adjustment (p<0.0261). In patients with low BMD (less than the cohort median, 180.6 HU), us‐cTnI was significantly associated with any presence of coronary artery calcium (CAC>0) in logistic regression models. This association was significant after adjustments for sex and other co‐morbidities, however, was not significant after adjusting for age.
Conclusions
In RA patients, us‐cTnI significantly correlated with lower BMD. Furthermore, higher concentration of us‐cTnI can independently predict the presence of coronary artery calcification in osteopenic RA subjects.
104: HYPERINSULINEMIC RESPONSE TO ENERGY DRINK INTAKE IN HEALTHY ADULTS: A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED CLINICAL TRIAL*†
Anna Svatikova, Naima Covassin, Kiran Somers, Prachi Singh, Krishen Somers, and Jan Bukartyk
Abstract Topic
ASCVD Prevention ‐ Primary and Secondary
Lead Author'S Financial Disclosures
Consulting activity: Sophos Capital Management, Menlo Park, CA.
Study Funding
None
Background/Synopsis
Energy drink consumption is increasing sharply among young adults. Concerns about their health risks have been raised due to the high content of caffeine, sugar, and other stimulants in energy drinks. It has been shown that caffeine ingestion may alter glucose metabolism and insulin sensitivity. While attention has focused on their effects on cardiovascular risk, little is known about their metabolic consequences.
Objective/Purpose
We examined the effects of energy drink consumption on glucose levels and on insulin secretion.
Methods
We studied 24 healthy subjects age 29±1 years in a randomized, double‐blind, placebo‐controlled, crossover study. Caffeine intake history was recorded. Subjects consumed a can (473 ml) of commercially available Rockstar energy drink and a placebo drink (with similar sugar content) on two separate days in random order. Blood glucose and insulin levels were obtained before and 30 minutes after drink consumption and were compared between caffeine naïve subjects (n=11, consuming <160 mg of caffeine per day) and regular caffeine users (n=13, consuming ≥160 mg of caffeine per day).
Results
Compared to the placebo, the energy drink increased insulin secretion (from 7±1 μIU/mL to 74±10 μIU/mL by 1053±92% versus after placebo from 7±1 μIU/mL to 60±10 μIU/mL by 782±92%, P=0.04). This hyperinsulinemic response was further accentuated in regular caffeine users, in whom insulin increased after energy drink by 1173±101% versus by 675±101% after placebo (P=0.002). In caffeine naïve subjects, both placebo and Rockstar increased insulin similarly (909±158% vs 911±158% respectively, P=NS). Glucose levels were comparable after energy drink and placebo consumption in both groups. Baseline Homeostasis Model Assessment of Insulin Resistance Index was similar between the caffeine naïve and caffeine users suggesting that subjects were free of underlying insulin resistance.
Conclusions
In young adults, energy drink consumption leads to a greater surge in insulin secretion. This response is even more accentuated in regular caffeine users compared to caffeine naïve subjects. Hyperinsulinemia triggered by repetitive energy drink intake may potentially lead to impaired glucose homeostasis. Chronic energy drink use may conceivably contribute to development of cardiometabolic derangements and increased cardiac risk even in healthy adults.
105: CORRELATION OF RED BLOOD CELL DISTRIBUTION WIDTH, CYS C, AND HS‐CRP WITH CARDIOVASCULAR EVENTS IN PATIENTS
Dili xie, Biao Cheng, Yong Sheng, and Jing Jin
Abstract Topic
ASCVD Risk Assessment
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Recent studies have suggested that red blood cell distribution width (RDW), serum Cystatin C (Cys C), and high‐sensitivity C‐reactive protein (hs‐CRP) may be valuable in the diagnosis and treatment of cardiovascular disease.
Objective/Purpose
This study aims to improve the diagnosis and treatment of ASTEMI and explore the clinical significance of Cys C and hs‐CRP in patients with acute coronary syndromes (ACS).
Methods
The clinical characteristics of 189 patients with ASTEMI and the cardiovascular events were collected from January 2013 to March 2014 in Sichuan Provincial People's Hospital. The cardiovascular survival rate of patients with different ASTEMI in RDW was estimated by Kaplan‐Meier method and compared with Log‐rank test. The prognostic factors of ASTEMI patients were investigated by Cox proportional hazards regression model. Serum Cys C and hs‐CRP levels were measured to observe the relationship with coronary artery Gensini score and ACS.
Results
There were 97 patients with RDW >13.7% and 92 patients with RDW ≤3.7%. The hs‐CRP, BNP, LVEF, and HDL‐C were statistically significant (P<0.05). The incidence of cardiovascular events in patients with recurrent myocardial infarction, newly diagnosed heart failure, and sudden cardiac death was higher than that in low RDW group (P<0.05). A total of 60 patients with high RDW had a cardiovascular event with a one‐year survival rate (38.1%) without cardiovascular events. Twenty percent of patients with low RDW had cardiovascular events. The one‐year cardiovascular survival rate was 79.3% (P<0.001). RDW >13.7% was the risk factor for the prognosis of ASTEMI patients. The levels of serum Cys C and hs‐CRP in ACS patients were positively correlated with Gensini score of coronary artery (P<0.05).
Conclusions
RDW was correlated with cardiovascular disease in ASTEMI patients. Elevated RDW increases the risk of cardiovascular events in ASTEMI patients with poor prognosis. The elevated serum Cys C and hs‐CRP levels were the risk factors of ACS.
106: VALIDATION OF THE ACC/AHA POOLED COHORT EQUATIONS FOR CARDIOVASCULAR RISK ASSESSMENT: A META‐ANALYSIS*
Anurag Mehta, Rohan Khera, Parag Joshi, Khurram Nasir, Amit Khera, and Ambarish Pandey
Abstract Topic
ASCVD Risk Assessment
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Validation studies assessing performance of the ACC/AHA pooled cohort equations (PCE) to predict ASCVD risk have revealed conflicting results. A quantitative synthesis of these studies, particularly in sub‐groups of sex and race/ethnicity, is critical given the important clinical decisions predicated on PCE predicted risk thresholds.
Objective/Purpose
To perform a systematic review and contemporary meta‐analysis of studies validating PCE performance.
Methods
Through a critical review of MEDLINE, EMBASE, and Cochrane Central databases from January 2011 to December 2016, we identified all studies assessing discrimination and/or calibration of PCE in adults without clinical ASCVD. We abstracted data for overall as well as sex and race/ethnicity‐specific model characteristics, concordance statistic (or c‐statistic; model discrimination), and the expected‐to‐observed (E/O) events (model calibration). Study quality was assessed on the CHARMS checklist using the PICOTS criteria.
Results
Seventeen validation cohorts with 717,996 participants (mean age 53.7 years, 56% women, 44% white, 4% black, and 49% Asian), 20,887 ASCVD events, and 5,764,476 person‐years of follow‐up were included. Most studies were of moderate‐to‐good quality. Given the substantial heterogeneity across studies, study‐level estimates were pooled in a random effects meta‐analysis. In pooled analyses, the PCE showed modest discrimination across all studies with an overall pooled c‐statistic of 0.73 (95% CI 0.71, 0.75). Similar discrimination was observed in sub‐groups stratified by sex and race/ethnicity. In assessing model calibration, there was a 44% overestimation of risk (pooled E/O ratio 1.44 [1.33‐1.54]) across all studies. Miscalibration was similar among men (E/O ratio 1.48 [1.38‐1.59]). PCE was better calibrated among women, with a smaller and non‐significant overestimation of risk (E/O ratio 1.15 [0.93, 1.42]). Further, there was a significant interaction by race/ethnicity among women (P <0.05), with a 50% overestimation of risk in studies of predominantly white women compared with 20% underestimation of risk among studies of predominantly Asian women.
Conclusions
While the ACC/AHA PCE shows modest discrimination across demographic groups, there is consistently a nearly 50% overestimation of ASCVD risk among white women and among all men. However, studies of Asian women suggest a 20% underestimation of risk. These findings may have significant implications for clinical decision‐making.
107: VALIDATION OF THE 2013 ACC/AHA POOLED COHORT EQUATION FOR 10‐YEAR ATHEROSCLEROTIC CARDIOVASCULAR RISK ASSESSMENT IN A CONTEMPORARY, COMMUNITY‐BASED HISTORICAL COHORT*†
Jose Medina‐Inojosa, Virend Somers, Mariana Garcia, Rajeev Chaudhry, Thomas Randal, Sharon Mulvagh, and Francisco Lopez‐Jimenez
Abstract Topic
ASCVD Risk Assessment
Lead Author'S Financial Disclosures
None
Study Funding
This work was supported in part by project number LQ1605 from the National Program of Sustainability II (MEYS CR) (To FLJ), National Institute of Health (NIH) grants (R01HL65176 and R01HL114024 to VKS), and resources of the Rochester Epidemiology Project (REP), which is supported by the National Institute of Aging under Award Number R01AG034676.
Background/Synopsis
The 2013 ACC/AHA Pooled Cohort Equation (AHA Risk Calculator) for atherosclerotic cardiovascular disease (ASCVD) has been shown to accurately predict ASCVD events in some cohorts, but its accuracy in contemporary community‐based populations with at least 10‐year follow‐up has not been performed.
Objective/Purpose
We tested the hypothesis that the AHA Risk Calculator will accurately estimate the 10‐year ASCVD risk in the population.
Methods
Using the Rochester Epidemiology Project we performed a validation of the AHA Risk Calculator on a community‐based cohort of all consecutive patients that sought primary care in Olmsted County, Minn. between the years 1998‐2000 and were followed up through March 1, 2016. Inclusion criteria were age 40‐79 years and complete data to calculate the 10‐year risk. We excluded those with known ASCVD at baseline, atrial fibrillation, or heart failure. Criteria were similar to those used to derivate the AHA Risk Calculator. ASCVD events were validated in duplicate and included fatal and non‐fatal myocardial infarction (MI) and ischemic stroke. Patient information was ascertained using the record linkage system of the Rochester Epidemiology Project. For the purpose of validation analysis, follow‐up was truncated at 10 years. We compared the calculated and observed 10‐year ASCVD risk across predefined risk groups and calculated c‐statistics using the continuous risk score as the main predictor.
Results
We included 23,629 adults, mean age (SE) 53.7(0.06) years, 46% males, with a mean follow‐up of 16.1(0.01) years. There were 1,237 ASCVD events (5.2%) at 10 years of follow‐up in 967 people; 766 non‐fatal MI, 255 MI deaths, 161 ischemic strokes, and 55 ischemic stroke deaths. The AHA Risk Calculator overestimated the 10‐year ASCVD risk at all risk levels. The overestimation of risk was more pronounced in subjects with an estimated risk >10%. The AHA Risk Calculator had a good discriminatory value (C statistic: 0.76).
Conclusion
In conclusion, the AHA Risk Calculator overestimates ASCVD risk in the community. These results have implications for the applicability of current cholesterol guidelines, as statin therapy is recommended on the basis of calculated ASCVD risk.
108: A PATIENT WITH VERY HIGH PLASMA HIGH‐DENSITY LIPOPROTEIN (HDL) AND SUDDEN CARDIAC ARREST*†
Wenliang Song, Ginger Milne, John Fahrenholz, Vineet Agrawal, Weijuan Li, Daniel Clark, John McPherson, John Oates, Dan Roden, and Macrae Linton
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
A 58‐year‐old female with plasma HDL of 110‐150 mg/dL suffers from a very debilitating facial flushing for the past several years. She also had two episodes of sudden cardiac arrests.
Objective/Purpose
We aim to find a pathological condition that can explain the constellation of symptoms this patient has, which may provide important insights of HDL metabolism.
Methods
We conducted extensive clinical work‐ups to evaluate her constellation of symptoms and basic laboratory experiments including HPLC/MS/MS to evaluate specific biomarkers for rare orphan diseases.
Results
This patient's coronary angiogram was normal. However, acetylcholine challenge produced significant coronary spasms. Bone marrow biopsy excluded systemic mastocytosis. Urinary prostaglandin D2 metabolites increased after flushing attacks, which suggests the patient has a condition of mast cell activation syndrome. Her clinical constellation of symptoms mimic the niacin's pharmacological effect. Genetic investigation may shed light on the mechanism of HDL metabolism and niacin's therapeutic effect.
Conclusions
Isolated mast cell activation syndrome may cause coronary spasms. Rare gene mutation may be responsible for her condition. Future genetics investigation may shed light on the mechanism of HDL metabolism.
109: AN ANALYSIS OF THE PATIENT POPULATION UNDERGOING A PCI TO DETERMINE THE EXISTENCE OF OBESITY PARADOX
Ammar Qureshi, Rodrigo Aguilar, and Mehiar El Hamdani
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Obesity and coronary artery disease are both increasing in prevalence. WHO estimated around more than 2.3 billion adults were overweight and 700 million were obese by 2015. Many studies have shown that overweight and obese patients have a better outcome in terms of cardiovascular outcomes. This is termed as the obesity paradox. The aim of our study was to compare the incidence of a presence of coronary artery disease as identified during percutaneous coronary intervention between the different strata based on their BMI.
Objective/Purpose
The aim of our study was to compare the incidence of a presence of coronary artery disease as identified during PCI between the different strata based on their BMI.
Methods
We studied the nationwide inpatient sample (NIS) from 2005‐2012. We selected those who underwent a left heart catherization within this period and divided them into two groups: patients who had a significant disease that required a PCI and those that did not require a PCI (including normal coronaries and non‐obstructive CAD). Using Propensity score matching, patients found to have abnormal coronary single or multiple vessels were matched with those who did normal vessels during PCI. These cohorts were then stratified based on their BMI. We divided them into four groups: normal, overweight (BMI 25‐30), obese (BMI 31‐40), and morbidly obese (BMI above 40).
Results
Between 2005 and 2012, 1.91 million people were admitted for left coronary catherization. 86.46% had a normal BMI, 0.34% were overweight, 13.51% were obese, and 3.72% were morbidly obese. The maximum proportion of patients who required a PCI was found in the overweight population (35.93% normal, 42.38% overweight, 33.52% obese, and 28.34% morbid obese, p<0.0001). Patients in the morbidly obese group had a lesser chance of undergoing a PCI. The all‐cause mortality was highest in the normal BMI patients (1.49% normal, 0.4% overweight, 0.77% obese, and 1.1% in morbidly obese, p<0.0001).
Conclusions
When analyzing the data, results showed that there were lesser chances patients undergoing a PCI were in the group with the highest BMI. The overweight population and normal population seemed to have the greatest risk for abnormal vessels. A limitation of our study was that the population with normal BMI also included those that belonged to the underweight population. However, we could infer from our results that there is a lesser incidence of abnormal vessels in the extremely obese population, confirming that an obesity paradox does indeed exist.
110: UTILIZATION OF READILY AVAILABLE CLINICAL CHARACTERISTICS FOR THE ESTIMATION OF THE CORONARY ARTERY CALCIUM SCORE*
Subhi AlAref, Khalil Anchouche, Hao Wang, Kranthi Kolli, Daniel Berman, Tracy Callister, Augustin DeLago, Martin Hadamitzky, Joerg Hausleiter, Mouaz Al‐Mallah, Matthew Budoff, Philipp Kaufmann, Gilbert Raff, and Kavitha Chinnaiyan, Filippo Cademartiri, Erica Maffei, Todd C. Villines, Yong‐Jin Kim, Jonathon Leipsic, GudrunFeuchtner, Gianluca Pontone, Daniele Andreini, Hugo Marques, Ronen Rubinshtein, Stephan Achenbach, Leslee J. Shaw, Allison M. Dunning, Millie Gomez, Niree Hindoyan, Fay Y. Lin, Jessica M. Peña, James K. Min, and Erica C. Jones
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Cardiovascular prevention is aimed at lowering incident adverse events in the highest risk individuals. The coronary artery calcium (CAC) score has been found to further risk stratifing patients beyond what is provided by traditional, population‐derived risk scores. The major limitation associated with performance of a CAC score is the requirement for non‐invasive image acquisition through low‐dose CT or coronary computed tomographic angiography (CCTA).
Objective/Purpose
We sought to utilize machine‐learning algorithms in order to develop a model capable of estimating an individual's CAC score category using readily available clinical parameters, hence obviating the need for radiation exposure and radiologic image acquisition.
Methods
The CONFIRM registry, which includes demographic, clinical and imaging parameters for 35,281 patients who underwent ≥64‐detector row CCTA evaluation because of either suspected or previously established coronary artery disease (CAD), was utilized. Patients were selected for whom clinical data and CAC score measurements were available. A gradient boosting machine learning algorithm (Xgboost) was employed for classification on the basis of CAC score (CAC=0, CAC 1‐100, CAC 101‐400, CAC>400). The dataset was split into training (70%) and validation (30%) sets. Model hyper‐parameters were fine‐tuned using four‐fold cross‐validation on the training set. Performance was measured using the area‐under‐the‐curve (AUC).
Results
Approximately 18,628 patients were included in the analysis, of which 9,180; 4,676; 2,401; and 2,371 were found to have a CAC = 0, 1‐100, 101‐400, and >400, respectively. Compared to patients with CAC score <400, patients with higher scores were more likely to be older male patients with typical cardiovascular risk factors (hypertension, hyperlipidemia, diabetes, and current smokers). These patients were also more likely to be on medical therapy at baseline. Overall, the AUC for CAC score = 0, 1‐100, 101‐400, and >400 were 0.835, 0.674, 0.739, and 0.853, respectively.
Conclusions
A machine‐learning algorithm that incorporates readily available clinical characteristics can accurately estimate the CAC score category. Given the large body of literature outlining both the diagnostic and prognostic utility of the CAC score, such a model may prove effective in enhancing clinical decision‐making, while reducing costs and radiation exposure.
111: RADIATION DOSE REDUCTION BY USING 80KV MULTI DETECTOR COMPUTED TOMOGRAPHY*†
Panteha Rezaeian, Rine Nakanishi, Yanting Luo, Anas Alani, Suguru Matsumoto, Aryabod Razipour, and Matthew Budoff
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Multi‐slice computed tomography angiography (MDCT) is a robust modality for imaging patients with suspected structural heart abnormality or coronary artery disease. Invention of the 64‐slice MDCT (0.6‐ versus 1.0‐mm slice thickness and 330‐ versus 420‐ms gantry rotation time) resulted in revolutionary improvement in spatial and temporal resolution of images by the cost of increasing the radiation dose exposure. Reduced tube voltage can overcome this hindrance.
Objective/Purpose
This study was designed to quantify the radiation dose saved by reduction tube voltage applied to MDCT.
Methods
Radiation dose was estimated for 394 patients undergoing coronary CTA. An 80Kv protocol was used for 112 participants (mean age=65.21±14.47) and 282 participants (mean age= 59.33±12.52) underwent 120Kv MDCT. The impact of 80Kv protocol was investigated on length product (DLP) and radiation dose (millisievert: mSv). Scanning algorithms with and without an ECG‐dependent dose modulation and with reduced tube voltage were assessed on dose estimates.
Results
Mann‐Whitney U test was used for comparison across groups. Reducing tube voltage from 120 to 80Kv resulted in a 72.2% decrease in DLP CTA (p‐Value, <.0001). In the entire cohort, radiation dose estimates were reduced 72.9% for mSv CTA (p‐Value, <.0001). There was substantial inter‐observer agreement.
Conclusions
A decrease in tube voltage from 120 to 80Kv results in a significant decrease in radiation dose.
112: IMPACT OF DISCLOSURE OF GENETIC RISK FOR CORONARY HEART DISEASE ON IMPLEMENTATION OF AN ACTION PLAN FOR LIFESTYLE MODIFICATION: THE MI‐GENES STUDY*
Sherry‐Ann Brown and Iftikhar Kullo
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
This study was part of the NHGRI‐funded supported eMERGE (Electronic Records and Genomics) Network (U01HG04599 and U01HG006379). The Mayo Clinic Biobank was funded by the Mayo Clinic Center for Individualized Medicine. Use of REDCap was funded by the Center for Clinical and Translational Science grant support (UL1TR000135). Approved by: Mayo Clinic Institutional Review Board on 6‐28‐2013.
Background/Synopsis
Disclosing a genetic risk score (GRS) for coronary heart disease (CHD) influences implementation of an action plan for lifestyle modification is unknown.
Objective/Purpose
We sought to investigate whether disclosing genetic risk for CHD promotes implementation of an action plan for physical activity and dietary changes.
Methods
Participants (n=203) of ages 45‐65 years, at intermediate risk of CHD and statin‐naïve, were randomized in the Myocardial Infarction Genes (MI‐GENES) trial to receive their conventional Framingham risk score (CRS) alone or in addition a 28‐variant GRS. At the time of CHD risk disclosure, participants discussed an action plan for lifestyle modification with a genetic counselor. Surveys for physical activity and dietary habits were administered immediately, three and six months after risk disclosure. Surveys for action plan utility were completed at three and six months after risk disclosure. We determined whether responses differed by GRS disclosure, or by H‐GRS (GRS≥1.1) or L‐GRS (GRS<1.1). Data were analyzed by logistic regression, adjusted for sociodemographic characteristics, and reported as odds ratio with confidence interval or mean with standard error.
Results
At six months post‐disclosure, GRS participants were more likely than CRS participants to find the action plan helpful for making healthier dietary changes (OR 1.95, CI 1.07‐3.61, p=0.03). Interestingly, this effect seemed to be primarily due to the L‐GRS participants compared to CRS participants (OR 2.55, CI 1.16‐5.8, p=0.02). GRS participants were also more likely than CRS participants to find the action plan helpful for increasing physical activity (OR 1.8, CI 1.01‐3.22, p=0.045). In addition, study participants' finding the action plan useful for increasing physical activity was a predictor of actual self‐reported vigorous physical activity (5.44±0.15 versus 5.04±0.13, p=0.03). Notably, L‐GRS participants were more likely than CRS participants to actually self‐report vigorous physical activity (5.64±0.21 versus 5.05±0.14, p=0.01).
Conclusions
Genetic risk disclosure promoted implementation of an action plan for physical activity and dietary changes, particularly in individuals with low GRS.
113: APPROPRIATE‐DOSE STATIN THERAPY IN ADULT PATIENTS WITH ELEVATED LOW‐DENSITY LIPOPROTEIN (LDL‐C)*
Mubashir Bahrami, Jacquelyn Kulinski, Jessica Bellone, Christopher Koo, Alexis Visotcky, and Chelsea Reed
Abstract Topic
ASCVD Risk Factors
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
One of the targeted groups for statin therapy in the 2013 ACC/AHA cholesterol treatment guidelines includes adult patients with an LDL‐C ≤190 mg/dL. Even with appropriate‐dose statin therapy per the guidelines, this population may benefit from additional therapies to achieve an optimal LDL‐C.
Objective/Purpose
The objective of the study is to characterize lipid‐lowering treatment in patients with a LDL‐C ≤190 mg/dL or non‐HDL‐C ≤220 mg/dL in the Froedtert Health System.
Methods
We performed a retrospective chart review of adult patients with a documented LDL‐C ≤190 mg/dL or non‐HDL‐C ≤220 mg/dL who had been prescribed a statin and who had a clinic encounter in the Froedtert Health System from January 1, 2015 to July 31, 2015. Appropriate‐dose statin therapy was defined as [1] high‐intensity statin for LDL‐C ≤190 mg/dL or [2] moderate or high intensity statin for non‐HDL ≤220 mg/dL depending on risk factors (diabetes, ASCVD risk).
Results
A total of 562 patients (57.4% female) with a mean age of 58±13.2 years were included. The mean baseline LDL‐C and non‐HDL C was 204.2±37.3 and 253.1±46.1 mg/dL, respectively. There were 221 patients (39.3%) treated with appropriate therapy. A similar percentage of females and males were on appropriate therapy (39.4% vs 39.3%, p=0.979). Sixty‐eight (19.9%) patients not on appropriate statin therapy had a rationale documented, most commonly muscle symptoms. A total of 113 (20.2%) patients were on additional lipid‐lowering therapy, which most commonly included fish oil and fibrates. There was a non‐significant trend towards appropriate‐dose statin therapy by specialists (cardiology and endocrine) when compared with any other type of provider (50.9% and 38.0%, p value=0.06). Of the patients prescribed appropriate therapy, 68 patients (30.7%) require additional LDL lowering to achieve an optimal LDL‐C.
Conclusions
A majority of the high‐risk patients in this study would benefit from either statin intensification and/or the addition of non‐statin therapies. Possible reasons for these shortcomings may include non‐compliance, medication intolerance, and prescriber unfamiliarity with guidelines, which should be explored in further studies. Early identification of these high‐risk patients and referral to specialists may be warranted.
114: EFFICACY AND SAFETY OF THE DABIGATRAN MONOTHERAPY IN ELDERLY PATIENTS WITH STABLE CORONARY HEART DISEASE AND NON‐VALVULAR ATRIAL FIBRILLATION
Dili Xie, Biao Cheng, Yong Sheng, and Jing Jin
Abstract Topic
ASCVD Risk Reduction
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
The embolic stroke is usually caused by atrial mural thrombosis, which is closely related to atrial fibrillation (AF). Anticoagulation is regarded as the core treatment for AF. However, when elderly patients above ninety years old receive anticoagulation, they face great risk of bleeding. Currently, for these cases with stable coronary artery disease (SCAD) and non‐valvular AF, both anticoagulant therapy alone and anticoagulant combined with antiplatelet therapy are used, but which is the optimal choice has always been the focus of clinical research.
Objective/Purpose
This study was conducted to compare the efficacy and safety among the combination therapy with dabigatran and clopidogrel, the dabigatran monotherapy and the warfarin monotherapy, to assess whether the dabigatran monotherapy being superior to others for the case of old‐age.
Methods
Sixty‐two elderly patients were divided randomly into the dabigatran group, the warfarin group, and the combination group with dabigatran and clopidogrel. After a one‐year follow‐up, the incidences of TIA, cerebral embolism, ACS, and hemorrhagic events were compared.
Results
There were no differences in the basic situation among the three. The incidences of TIA, cerebral embolism, and ACS in the dabigatran group and the combination group were significantly lower than that in the warfarin group, but there were no differences in these incidents between the combination group and the dabigatran group. The incidents of gastrointestinal, intracranial, and urinary tract bleeding in the combination group were significantly higher than the others. The incidents of gastrointestinal bleeding were similar in the dabigatran group and the warfarin group, but the incidents of intracranial and urinary tract bleeding in the dabigatran group were significantly lower than that in the warfarin group. Each group had no hemoptysis case. The combination group had one severe, non life‐threatening bleeding case.
Conclusions
For elderly patients with SCAD and non‐valvular AF, the efficacy of dabigatran monotherapy was not inferior to the combination therapy, and was superior to that of warfarin monotherapy. But the bleeding risk of dabigatran monotherapy was significantly lower than that of the two other therapies. Therefore, for such patients, the dabigatran monotherapy is a better choice.
115: EFFECT OF DIABETIC DURATION ON LEFT VENTRICULAR GLOBAL LONGITUDINAL STRAIN BY SPECKLE TRACKING IMAGING*
Ahmed Elgohary
Abstract Topic
Diabetes
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Diabetic patients with normal left ventricular ejection fraction are frequently associated with diastolic dysfunction. Speckle tracking is more sensitive than LVEF in detection of subclinical LV systolic dysfunction. However, it is not clear whether there is any difference in early LV systolic dysfunction between DM patients if they have controlled or uncontrolled blood glucose; and what is the duration of DM that contributes to preclinical impairment of LV systolic function.
Objective/Purpose
Detection of different patterns of global longitudinal strain in diabetic patients using global longitudinal strain by speckle tracking and trying to specify the time needed for DM to affect LV systolic function.
Methods
Fifty‐two diabetic patients had been referred from internal medicine clinic after they had been tested for HBA1c test and stratified into two groups. Group I includes 26 DM patients (< or > five years) with controlled blood sugar, and group II includes 26 DM patients (< or > five years) with uncontrolled blood sugar. The two groups had been subjected to the following diagnostic workup including the following: full medical history, full clinical examination, laboratory assessment, twelve lead resting ECG, stress ECG, echocardiography study, Traditional Tissue Doppler imaging, and assessment of global longitudinal strain. Patients with ischemic heart disease, systolic dysfunction, congenital heart disease, salvular (stenosis or regurge of all cardic valves, arrhythmia, hypertrophic obstructive cardiomyopathy, pericardial (constrictive pericarditis, pericardial effusion), and major systemic disease had been excluded.
Results
There was significant statistical differences in the GLS (global longitudinal strain), age, diabetic type, diabetic duration, 2HPP blood sugar level, and E/A ratio in the controlled DM compared to uncontrolled DM (p<0.05). There were significant statistical differences in GLS in (<5years to >5years) diabetic duration (p<0.05), but there was no significant difference in Gender, FBS. EF, and E/A in controlled DM compared to uncontrolled DM.
Conclusions
Diabetic duration was strongly correlated with reduction of global longitudinal strain. 2DSTE has the potential for detecting subclinical LV systolic dysfunction, and it might provide useful information for the risk stratification of an asymptomatic diabetic population.
116: DIASTOLIC BLOOD PRESSURE AND ADVERSE OUTCOMES IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION
Pratik Sandesara, Devinder Dhindsa, Wesley O'Neal, Jay Khambhati, Laurence Sperling, and Suegene Lee
Abstract Topic
Heart Failure
Lead Author'S Financial Disclosures
None
Study Funding
Funding provided by Abraham J. & Phyllis Katz Foundation, Atlanta, GA, and the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number F32‐HL134290.
Background/Synopsis
Systemic hypertension is implicated in the pathogenesis of heart failure with preserved ejection fraction (HFpEF). However, there is limited data on hypertension treatment goals in patients with established HFpEF. Previous studies in the general population have shown that excessive reduction of diastolic blood pressure (DBP) may be associated with increased risk of adverse cardiovascular outcomes, suggesting a "J‐shaped" relationship with DBP below 70 to 80 mmHg. However, it is unclear if this relationship exists in patients with HFpEF.
Objective/Purpose
We sought to examine the association between levels of DBP and outcomes in patients with HFpEF.
Methods
In total, 3,358 (mean age=69±9.6 years; 48% male; 89% white) patients with HFpEF who were treated for hypertension from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT) were studied. Outcomes included hospitalization for heart failure, myocardial infarction, death, and cardiovascular death. Cox regression was used to examine the risk of each outcome associated with DBP. We also examined the risk of low DBP across values of systolic blood pressure (SBP) <130 mmHg and ≥130 mmHg. Models were adjusted for age, sex, race, smoking, systolic blood pressure, diabetes, body mass index, aspirin, antihypertensive medications, statin, randomization group, New York Heart Association Class, coronary heart disease, and stroke.
Results
An increased risk of hospitalization for heart failure (per 5 mmHg decrease in DBP: HR=1.19 95% CI=1.13, 1.25), myocardial infarction (HR=1.15, 95% CI=1.04, 1.27), death (HR=1.09, 95% CI=1.03, 1.14), and cardiovascular death (HR=1.06, 95% CI=1.00, 1.14) was observed with lower values of DBP. The survival probability of participants across DBP values are shown in Figure 1 (log‐rank p<0.001). When the analysis was stratified by systolic blood pressure ≥130 versus <130 mmHg, the magnitude of the associations between DBP <70 mmHg and hospitalization for heart failure (HR=2.34, 95% CI=1.71, 3.20), death (HR=1.78, 95% CI=1.36, 2.33), and cardiovascular death (HR=1.80, 95%CI=1.27, 2.55) was greater in those with SBP values <130 mmHg than those with SBP ≥130 mmHg.
Conclusions
Lower DBP levels, particularly <70 mmHg, are associated with adverse outcomes in HFpEF patients. Additionally, the magnitude of the association between DBP <70 mmHg and adverse outcomes may be magnified in HFpEF patients who are treated to SBP values <130 mmHg.
117: HSCRP AND PRO‐BNP: MARKERS FOR EARLY CARDIOVASCULAR STRUCTURAL AND FUNCTIONAL ABNORMALITIES IN ASYMPTOMATIC SUBJECTS?
Mahfouz El Shahawy and Antonella Sabatini
Abstract Topic
Novel Biomarkers
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Carotid Intima‐Media Thickness (CIMT) has been largely studied and used as an early sign for subclinical atherosclerosis. Abnormal CIMT and C2 as well as abnormal pro‐BNP are also known to be early markers for cardiovascular disease (CVD).
Objective/Purpose
The purpose of this study is to assess whether elevated biomarkers, i.e. hsCRP or Pro‐BNP, are indicative for the presence of cardiovascular structural and functional abnormalities as depicted by abnormal CIMT and C2 in asymptomatic subjects taking no CV medications.
Methods
We screened 2,406 asymptomatic subjects, age 20‐79, for CVD risk using the Early Cardiovascular Disease Risk Scoring System (ECVDRS), which consists of 10 tests including the following: large (C1) and small (C2) artery stiffness, blood pressure (BP) at rest and post mild exercise (PME), Carotid Intima Media Thickness (CIMT), abdominal aorta and left ventricle ultrasound (LVUS), retinal photography, microalbuminuria, ECG, and pro‐BNP. Abnormal blood pressure rise post mild exercise (BPrisePME) was defined as systolic BP rise >30mmHg post three‐minute walk at 7% elevation, 2.5mph. Normotension (NT), pre‐hypertension (pre‐HTN), and hypertension (HTN) were defined according to JCN7 criteria. High Sensitivity C‐reactive protein (hsCRP) was defined as normal <0.1 mg/L, borderline 0.1‐0.3 mg/L, abnormal > 0.3 mg/L. In this work, abnormal hsCRP >= 0.1mg/L.
Results
Among the 2,406 subjects (1,292 female and 1,198 male), 1,516 were asymptomatic with no CV medication. Among these, 446 (29%) had no CV comorbidities, 231 (15%) had abnormal waist with no other CV comorbidities, and 567 (37%) had abnormal waist with possible other CV comorbidities.
Conclusions
Based on our data, the group of subjects with no CV comorbidities hsCRP and pro‐BNP do not seem to correlate with abnormal CIMT and C2 with statistical relevance. Also, the group of subjects with abnormal waist circumference and no other CV comorbidities, abnormal pro‐BNP indicates a positive correlation with structural and functional abnormalities (abnormal CIMT and C2), whereas hsCRP denotes no correlation. The group of subjects with abnormal waist circumference suggests a positive correlation between abnormal pro‐BNP and abnormal CIMT (61%), with statistical significance.
Accordingly, abnormal pro‐BNP can be used as a marker for early CV structural and functional abnormalities in asymptomatic subjects, implicating the need for further studies for stratification of CVD in asymptomatic subjects.
118: CORRELATION OF ULTRA‐SENSITIVE CARDIAC TROPONIN‐I AND INFLAMMATORY BIOMARKER INTERLEUKIN‐6 WITH HEART‐SCORES IN RHEUMATOID ARTHRITIS: USING MULTI‐SLICE COMPUTED TOMOGRAPHY ANGIOGRAPHY*†
Panteha Rezaeian, Joel Estis, John Todd, Matthew Budoff, and George Karpouzas
Abstract Topic
Novel Biomarkers
Lead Author'S Financial Disclosures
None
Study Funding
The study was funded by a grant from the American Heart Association.
Background/Synopsis
Cardiovascular mortality in Rheumatoid Arthritis (RA) is 50‐60% higher compared to the general population. The inflammatory profile of RA may play an integral role in this scenario. We examined the hypothesis that Ultra‐sensitive Troponin‐I (cTnI) and inflammatory biomarkers can predict coronary atherosclerosis burden in patients with RA.
Objective/Purpose
The purpose of this study is to explore correlation of Ultra‐sensitive Cardiac Troponin‐I and interleukin‐6 with Heart‐scores and coronary artery plaque measurement.
Methods
One hundred and fifty RA patients (age 53±11 years) underwent 64‐slice computed tomography angiography (CTA). Coronary artery vessels were assessed by using a standardized AHA 15‐segment model. We evaluated coronary artery calcification (CAC), segment stenosis score (SSS), segment involvement score (SIS), and total plaque severity score (TPS) for patients blinded to their clinical symptoms. Ultra‐sensitive cardiac Troponin‐I (cTnI) and the inflammatory marker interleukin‐6 (IL‐6) were quantified in plasma collected at the time of CTA using the Erenna® System (Research Use Only, Singulex Inc., Alameda, CA).
Results
The cTnI positively trended with plaque prevalence across all heart‐scores. The cTnI significantly predicted CAC, SIS, SSS, and TPS (ORs 3.9, 2.5, 2.4, 2.5; respectively), while IL‐6 significantly predicted TPS (OR 2.1) in unadjusted logistical regression models. Multivariate logistic regression models, controlled for age and gender, determined that cTnI and IL‐6 were both independent predictors of TPS, while IL‐6 was an independent predictor of SIS.
Conclusions
Elevated concentration of biomarkers of cardiac dysfunction (cTnI) and inflammation (IL‐6) has incremental value for prediction of coronary artery atherosclerosis burden in patients with RA.
119: COMPARISON OF VISCERAL AND BODY FAT INDICES AND ANTHROPOMETRIC MEASURES FOR PREDICTING THE CLUSTERING OF CARDIOMETABOLIC RISK FACTORS BY GENDER AMONG AMONG POPULATION AGED 35 YEARS OLD OR OVER IN TIBET AND XINJIANG AREA*
Jiali Wang
Abstract Topic
Obesity
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Visceral and body fat bioelectrical indices (percentage body fat, PBF; visceral fat index, VFI) had been suggested as better screening tools for detecting cardiometabolic risk factors.
Objective/Purpose
The purpose of this study is to compare the efficiency of bioelectrical indices and various anthropometric measures (body mass index, BMI; waist circumference, WC; waist‐to‐height ratio, WHtR) in detecting the clustering of cardiometabolic risk factors (CCRF) among population aged 35‐80 years in Tibet and Xinjiang area.
Methods
We conducted the community‐based cross‐sectional survey during June 2015 to March 2017 in 13 sample sites selected by stratified multistage random sampling method from Tibet and Xinjiang area. Approximately 7,564 residents age 35‐80 years old were included and 5,558 (73.48%) participants were eligible for analysis. CCRF was defined by the existence of two or more of the following: high blood pressure, hyperglycemia, high TG level, and high HDL‐C level.
Results
The prevalence of CCRF was 18.33%. In both genders, VFI and PBF tended to rise with age (all P<0.05). However, for each age‐specific group, women consistently had significantly greater PBF than men (all P<0.01) and men had considerably higher VFI (all P<0.01). Both PBF and VFI were significantly associated with CCRF. The area under the ROC curves (AUCs) for BMI, WC, WHtR, PBF, and VFI, respectively, were 0.673, 0.683, 0.665, 0.627, 0.672 in men and 0.649, 0.664, 0.670, 0.643, 0.669 in women. In men, AUCs for VFI in detecting CCRF was not significantly higher than that for BMI, WC, and WHtR. In women, AUCs for VFI was significantly higher than that for BMI (P<0.01) but not for WC and WHtR; however, PBF had the lowest AUCs in both gender. Additionally, BMI yielded the greatest Youden index in identifying CCRF in men (0.27) and VFI yielded the greatest in women (0.26), respectively. Optimal cutoffs for VFI were 12 and nine in men and women, respectively.
Conclusions
VFI was a better screening tool for identifying CCRF in women than BMI but not superior to that of BMI in men. Both women and men should be highlighted to control excess visceral fat in preventing cardiometabolic diseases.
120: CHARACTERISTICS ASSOCIATED WITH WEIGHT GAIN IN THE DALLAS HEART STUDY*
Alina Brener, Colby Ayers, Ian Neeland, Sandeep Das, David Nelson, Tiffany Powell‐Wiley, Srividya Kidambi, and Jacquelyn Kulinski
Abstract Topic
Obesity
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Targeted interventions to prevent the cardiometabolic impact of obesity require an understanding of predictors of weight gain in diverse populations. Multiple longitudinal studies have demonstrated successful strategies and behaviors for weight loss, but studies characterizing predictors of weight gain are lacking.
Objective/Purpose
The purpose of this study is to use the Dallas Heart Study (DHS) cohort to identify characteristics associated with weight gain including the effect of fat mass and obesity‐associated gene (FTO) variants on weight change.
Methods
DHS is a multi‐ethnic, population‐based probability sample of Dallas County residents (n=2,938) followed prospectively. Using weight change over a median seven years of follow‐up as our outcome variable of interest, we used solution of fixed effects regression models to analyze the following covariates: age, sex, race/ethnicity, education level, income level, alcohol intake and smoking status, physical activity, FTO gene variants, and neighborhood deprivation index. We excluded subjects with a history of congestive heart failure, liver cirrhosis, end‐stage renal disease, pregnancy, and loop diuretic use.
Results
Higher baseline physical activity, active smoking, and higher alcohol intake were associated with weight loss (all p<0.02). Male sex, higher income, and increased age were associated with weight gain (all p<0.05). However, when stratified by race/ethnicity and sex, Hispanic males lost weight over time when compared to African Americans and Caucasians (p<0.006). African American women gained more weight over time when compared to Hispanic or Caucasian women (p<0.001). Interestingly, the FTO gene variants did not independently correlate with weight gain in the DHS cohort. However, the at‐risk AA FTO gene variant was associated with increased waist‐to‐hip ratio in women, but not in men (p<0.003).
Conclusions
When controlled for a number of social and biological variants, race and sex were major contributors to weight change in the DHS cohort. Identifying additional characteristics that contribute to weight gain will increase our understanding of potential barriers to maintaining a healthy body weight, and are important for further development of preventive strategies to curb the obesity epidemic.
121: THE ASSOCIATION BETWEEN ADIPOSITY AND LEAN MASS WITH LONG‐TERM CARDIOVASCULAR EVENT IN PATIENTS WITH CORONARY ARTERY DISEASE: A POPULATION‐BASED STUDY*
Jose Medina‐Inojosa, Virend Somers, Randal Thomas, Nathalie Jean, Sarah Jenkins, Miguel Gomez‐Ibarra, Shawn Leth, and Francisco Lopez‐Jimenez
Abstract Topic
Obesity
Lead Author'S Financial Disclosures
None
Study Funding
This work was supported in part by project number LQ1605 from the National Program of Sustainability II (MEYS CR) (To FLJ) and NIH grant (R01HL65176 and R01HL114024 to VKS). This publication was made possible in part by CTSA grant number UL1TR000135 from the National Center for Advancing Translational Sciences (NCATS), and resources of the Rochester Epidemiology Project (REP), which is supported by the National Institute on Aging under award number R01AG034676. Both are components of the National Institute of Health (NIH).
Background/Synopsis
Prognosis based on body fat percent (BF%) in patients with coronary artery disease (CAD) has not been extensively studied.
Objective/Purpose
We tested the hypothesis that patients with CAD and increased body fat have a higher risk for major adverse cardiovascular events (MACE) and that high lean mass is associated with better prognosis.
Methods
We included patients referred to cardiac rehabilitation (CR) following CAD events or procedures that underwent air displacement plethysmography to assess BF%. Follow‐up was performed using a record linkage system from the Rochester Epidemiology Project. Patients were classified in sex‐specific quintiles of BF% and lean mass index. The composite outcome of MACE included acute coronary syndromes, coronary revascularization, ventricular arrhythmias, stroke, or death from any cause.
Results
We included 717 patients, 75% males with mean age 61.4± 11.4 years, and mean BMI of 30±5.4 kg/m2. After a median follow‐up of 3.9 years, 204 patients had a MACE. After adjusting for covariates BMI was not associated with MACE (p for trend=0.20). However, the risk of MACE for those in the highest BF% quintile was double when compared to the lowest quintile (HR 2.04, 95% CI: 1.34‐3.14, p=0.001). In contrary, lean mass was inversely associated with MACE. For each unit increase of lean mass index expressed by kg/m2, incidence of MACE was 7% lower (HR 0.93 per unit, p= 0.03).
Conclusions
In patients with CAD there is no obesity paradox when measuring body fat instead of using BMI. BF% is directly associated with a higher risk of MACE, while lean mass is associated with a lower risk of MACE. BMI was not associated with MACE.
122: THE ASSOCIATION BETWEEN WAIST‐HIP RATIO WITH LONG‐TERM CARDIOVASCULAR EVENTS IN PATIENTS WITH CORONARY ARTERY DISEASE: A POPULATION‐BASED STUDY*
Jose Medina‐Inojosa, John Batsis, Marta Supervia, Virend Somers, Randal Thomas, Sarah Jenkins, Chassidy Grimes, and Francisco Lopez‐Jimenez
Abstract Topic
Obesity
Lead Author'S Financial Disclosures
None
Study Funding
This work was supported in part by project number LQ1605 from the National Program of Sustainability II (MEYS CR) (To FLJ) and National Institute of Health (NIH) grants (R01HL65176 and R01HL114024 to VKS). Dr. Batsis is supported in part by the National Institute on Aging under award number K23AG051681 with administrative support from the Dartmouth Health Promotion and Disease Prevention Research Center (Cooperative Agreement Number U48DP005018) from the Centers for Disease Control and Prevention. This publication was made possible in part by CTSA grant number UL1TR000135 from the National Center for Advancing Translational Sciences (NCATS), and resources of the Rochester Epidemiology Project (REP), which is supported by the National Institute of Aging under award number R01AG034676. Both are components of the NIH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding sources.
Background/Synopsis
While increased body mass index (BMI) has been associated with better survival, central obesity has been linked to increased mortality in patients with established coronary artery disease (CAD). However, the association between obesity and major adverse cardiovascular events (MACE), including non‐fatal events, in patients with CAD has not been reported.
Objective/Purpose
The purpose of this study is to assess the association between measures of obesity and clinical outcomes in CAD patients.
Methods
We included consecutive patients referred to cardiac rehabilitation because of prior CAD events who were classified used standard criteria for obesity using BMI groups and in sex‐specific tertiles of waist‐to‐hip ratio (WHR). Follow‐up was ascertained using a population‐based, record linkage system that consists of complete data on all residents. We defined MACE as the composite outcome including acute coronary syndromes, coronary revascularization, ventricular arrhythmias, stroke, or death from any cause. The association between obesity measures and MACE was assessed using proportional hazards models adjusted for potential confounders.
Results
The cohort included 1,529 patients (74% men) mean age ± SD 63.1±12.5 years, 40% were obese by BMI. Eighty‐eight percent of men and 57% of women were classified as having central obesity by WHR. Median follow‐up was 5.7 years, and 415 patients had a MACE event. After adjustment for potential confounders, a high WHR tertile was a significant predictor for MACE in women (HR=1.85 [95% CI: 1.16, 2.94]; p=0.01), but not in men (HR=0.92 [95% CI: 0.69, 1.22]; p=0.54). This relationship in women persisted after further adjustment for BMI (HR=1.75 [95% CI: 1.07, 2.87]; p=0.03). Obesity by BMI was not associated with MACE in either men (HR=1.07 [95% CI: 0.76, 1.51]; p=0.69) or women (HR=0.98 [95% CI: 0.62, 1.56]; p=0.95).
Conclusions
WHR is associated with a higher risk of MACE among women with CAD but not in men. There was no obesity paradox when assessing obesity and MACE in CAD patients when including non‐fatal events.
123: EXAMINING THE HIGH DISEASE BURDEN AND IMPACT ON QUALITY OF LIFE IN FAMILIAL CHYLOMICRONEMIA SYNDROME‐ RESULTS FROM THE INFOCUS STUDY
Michael Davidson, Michael Stevenson, Andy Hsieh, Zahid Ahmad, and Jeanine Roeters van Lennep
Abstract Topic
Other
Lead Author'S Financial Disclosures
M. Davidson is a scientific advisory board member of Abbott, Amgen, AstraZeneca, Merck, and Sanofi Regeneron as well as a consultant for Akcea Therapeutics.
Study Funding
This study was funded by Akcea Therapeutics.
Background/Synopsis
Familial Chylomicronemia Syndrome (FCS) is a rare genetic disease characterized by marked accumulation of chylomicrons resulting in extreme hypertriglyceridemia. Patients manifest a constellation of signs, symptoms, and complications including recurrent pancreatitis, abdominal pain, eruptive xanthomata, asthenia, fatigue, and nausea/vomiting. This disease burden likely extends beyond the physical domain to include psychosocial and cognitive domains. To date, there have been no systematic efforts to characterize the impact of FCS on the burden of illness (BoI) and the impact on quality of life (QoL).
Objective/Purpose
The purpose of this study is to characterize the BoI in patients with reported FCS and assess the translation of the BoI on activities of daily living.
Methods
IN‐FOCUS was a comprehensive web‐based research survey of respondents with FCS focused on capturing the BoI and impact on QoL associated with the disease. One hundred sixty‐six respondents from 10 countries with reported diagnoses of FCS participated. Respondents described multiple burdens spanning across physical, emotional, and cognitive domains. Approval of this survey was obtained through IRB and various ethics committees.
Results
Patients on average cycled through five physicians of varying specialty before being diagnosed with FCS, reflecting a lengthy journey to an accurate diagnosis. Unemployment in this sample was 20%, and 94% of respondents reported a significant impact on career choice. Further, of the employed, 94% reported impairment in ability to fulfill work obligations. Respondents reported significant work loss due to their disease, reflected in an average of 24 days taken off over a 12‐month period. As there are no effective therapeutic agents for FCS, respondents reported multiple management strategies to mitigate disease burdens, each with attendant complications and impact on social activities and adherence challenges.
Conclusions
FCS imparts tremendous burden across multiple domains with considerable reported impairment on activities of daily living and QoL.
124: COMPARISON OF CARDIOPULMONARY EXERCISE TEST PERFORMANCE IN INFILTRATIVE CARDIOMYOPATHY*
Umama Gorsi, Thomas Allison, Jose Medina‐Inojosa, and Farzane Saeidifard
Abstract Topic
Other
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Patients with infiltrative cardiomyopathies frequently present with exercise‐limiting symptoms, including fatigue and shortness of breath. The prognostic role of cardiopulmonary exercise (CPX) testing in infiltrative cardiomyopathy is unknown.
Objective/Purpose
Our purpose was to describe the distribution of performance of patients with infiltrative cardiomyopathies on CPX in relation to age‐ and sex‐matched controls and compare the relative performance between cardiomyopathies.
Methods
We identified 97 patients retrospectively with confirmed diagnosis of an infiltrative cardiomyopathy (amyloid, carcinoid, or sarcoid) between January 2002 and December 2010. Differences in CPX variables by type of cardiomyopathy were assessed by analysis of variance according to the general linear model with adjustment for age, sex, BMI, and beta blocker use. Significance was set at p<0.05.
Results
In our cohort, there were 66 patients with amyloid, 15 carcinoid and 16 with sarcoid heart disease. Mean peak VO2, percent predicted peak VO2, and percent predicted peak heart rate after adjustment for clinical factors was lowest in amyloid patients (15.34 ml kg‐1 min‐1, 53.53% and 75% respectively) followed by sarcoid (19.72 ml kg‐1 min‐1, 61% and 77% respectively), and carcinoid (19.95 ml kg‐1 min‐1, 73.13% and 87 % respectively). VE/VCO2 nadir and RER did not vary significantly among the three groups (p= 0.14 and 0.11, respectively). Breathing reserve was highest among patients with amyloid, followed by carcinoid and sarcoid (56, 47, and 40%, respectively, p=0.002).
Conclusions
Exercise capacity is impaired in all groups of patients with infiltrative cardiomyopathies, and it is worst in patient with amyloidosis.
125: APOLIPOPROTEIN C‐III INHIBITION WITH VOLANESORSEN IN PATIENTS WITH HYPERTRIGLYCERIDEMIA (COMPASS): A RANDOMIZED, DOUBLE‐BLIND, PBO‐CONTROLLED TRIAL†
Ioana Gouni‐Berthold, Veronica Alexander, Andres Digenio, Robert Dufour, Elisabeth Steinhagen‐Thiessen, Steve Martin, Patrick Moriarty, Steve Hughes, Joseph Witztum, and Daniel Gaudet
Abstract Topic
Pharmacologic Therapy
Lead Author'S Financial Disclosures
Ioanna Gouni‐Berthold has received research grants from Bayer HealthCare, honoraria and support for educational activities from Aegereon, DACH Society from the prevention of cardiovascular diseases, Genzyme, Quintiles, Chiesi, MSD, Novartis, and Novo Nordisk.
Study Funding
This study was funded by Ionis Pharmaceuticals/Akcea Therapeutics.
Background/Synopsis
Apolipoprotein C‐III (apoC‐III) is a key regulator of plasma triglyceride (TG) levels. Loss of function mutations in APOC3 result in low TG levels and a reduction in cardiovascular risk. Elevated TG levels are associated with increased risk of pancreatitis and cardiovascular events.
Objective/Purpose
The COMPASS a randomized, multi‐center, double‐blind, placebo‐controlled, 26‐week, phase 3 study evaluated the effect of apoC‐III reduction with volanesorsen, a second‐generation antisense oligonucleotide, on fasting TG levels in patients with hypertriglyceridemia.
Methods
Patients with fasting TG ≥500 mg/dL, (n=113, mean ±SD, TG level 1,261±955mg/dL) were randomized 2:1 to receive 300 mg volanesorsen SC once a week or the placebo, respectively, for 26 weeks.
Results
Patients treated with volanesorsen (n=75) achieved a (mean ±SD) 72.7±17.4% reduction in TG (p<0.0001) from baseline at three months of treatment (primary endpoint), compared with a 1.8±53.0% reduction in placebo‐treated patients (n=38). This represented a mean absolute reduction of 869 mg/dL in treated patients. In a subset of seven patients with familial chylomicronemia syndrome (FCS) whose mean baseline TG levels were 2,280±973mg/dL, volanesorsen‐treated patients (n=5) achieved a mean TG reduction of 73±13.9% from baseline. Treatment effects were sustained through 26 weeks. There was also a statistically significant reduction (p=0.036) in pancreatitis events during treatment with volanesorsen compared to the placebo, with five events occurring in the placebo arm and none in the volanesorsen arm. One patient in the volanesorsen group had a pancreatitis event three months after the last dose. The most common adverse event was injection site reactions, occuring in 23.5% of volanesorsen injections. There were no serious platelet events in the study, although two patients discontinued from the volanesorsen TX group due to thrombocytopenia. There was one potentially related serious adverse event reported as serum sickness that occurred two weeks after the last study dose.
Conclusions
In patients with hypertriglyceridemia, treatment with volanesorsen 300 mg SC once a week was generally well‐tolerated and resulted in more than a 70% reduction in triglyceride levels in HTG and a significant reduction (p=0.036) in pancreatitis events for the patients treated with volanesorsen.
126: THE APPROACH STUDY: A RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED, PHASE 3 STUDY OF VOLANESORSEN ADMINISTERED SUBCUTANEOUSLY TO PATIENTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)†
Daniel Gaudet, Andres Digenio, Veronica Alexander, Marcello Arca, Alan Jones, Erik Stroes, Jean Bergeron, Fernando Civeira, Linda Hemphill, Dirk Blom, JoAnn Flaim, Steve Hughes, Richard Geary, Sam Tsmikas, Joseph Witztum, and Eric Bruckert
Abstract Topic
Pharmacologic Therapy
Lead Author'S Financial Disclosures
Dr. Gaudet received research grant support from FH Canada, Aegerion (Novelion Therapeutics), Amgen, Akcea Therapeutics a subsidiary of IONIS Pharmaceuticals, Astra Zenca, Chiesi, Cymabay, DalCor Pharma, Esperion, GlaxoSmithKiline, Gemphire, Ionis, Pfizer, Regeneron and Sanofi. He served as a consultant for Amgen, Aegerion, Akcea, Chiesi, Cymabay, IONIS, Sanofi Regeneron, and Uniqure.
Study Funding
This study was funded by Ionis Pharmaceuticals/Akcea Therapeutics.
Background/Synopsis
FCS is a rare genetic disease characterized by severe chylomicronemia, high plasma triglycerides, and risk of recurrent pancreatitis. The APPROACH study evaluated the efficacy and safety of volanesorsen, an antisense inhibitor of apoC‐III, in FCS patients on an extremely restricted low‐fat diet.
Objective/Purpose
The purpose of this study is to determine the efficacy of volanesorsen to reduce TGs at three months in patients with FCS.
Methods
This Phase 3 clinical trial enrolled 66 FCS patients with fasting triglycerides ≥8.4 mmol/L (≥750 mg/dL). Participants were randomized 1:1 to 52 weeks of weekly subcutaneous volanesorsen (300mg) or placebo. The primary efficacy endpoint (mean percent reduction in plasma triglyceride concentration) was evaluated at 13 weeks.
Results
Mean (SD) baseline triglycerides were 24.9 mmol/L (13.5) (2209 mg/dL [1199]). Week 13 triglycerides decreased by a mean (95% CI) of 77% (‐97.4, ‐55.5) in volanesorsen‐treated patients (n=33) and increased by 18% (‐4.0, 39.2) in placebo‐treated patients (n=33) (p<0.0001). This effect was sustained over the 52‐week treatment period (‐50.1% [‐71.4, ‐28.7]). Volanesorsen‐treated patients who reported at least two episodes of pancreatitis in the five years preceding randomization suffered no attacks during the 52‐week period (p=0.02). A reduction in self‐reported abdominal pain intensity was observed in patients who reported pain at baseline for the volanesorsen patients compared to the placebo (p=0.02). There were no treatment‐related renal or liver adverse events. The most common adverse event in the volanesorsen‐treated group was injection site reactions (11.8% of all injections). Declines in platelet counts led to five early terminations, two of which had platelets <25,000/μl.
Conclusions
Volanesorsen reduced triglycerides, abdominal pain, and recurrence of pancreatitis in FCS patients. Changes in platelets require surveillance and are manageable with frequent monitoring of platelet count.
127: RATIONALE AND DESIGN OF REDUCE‐IT: REDUCTION OF CARDIOVASCULAR EVENTS WITH ICOSAPENT ETHYL‐INTERVENTION TRIAL†
Deepak Bhatt, Gabriel Steg, Eliot Brinton, Terry Jacobson, Michael Miller, Jean‐Claude Tardif, Steven Ketchum, Ralph Doyle, Jr, Sabina Murphy, Paresh Soni, Rene Braeckman, Rebecca Juliano, and Christie Ballantyne
Abstract Topic
Pharmacologic Therapy
Lead Author'S Financial Disclosures
Dr. Bhatt has served on advisory boards for Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences. He has served on the board of directors for Boston VA Research Institute and Society of Cardiovascular Patient Care, and has been chair of the American Heart Association Quality Oversight Committee. Dr. Bhatt has served on data monitoring committees for Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and the Population Health Research Institute. He has received honoraria from the American College of Cardiology, Belvoir Publications, Duke Clinical Research Institute, Harvard Clinical Research Institute, HMP Communications, Journal of the American College of Cardiology, Population Health Research Institute, Slack Publications, Society of Cardiovascular Patient Care, and WebM. Dr. Bhatt has served as deputy editor of Clinical Cardiology, as chair of the NCDR‐ACTION Registry Steering Committee, and as chair of the VA CART Research and Publications Committee. He has received research funding from Amarin, Amgen, Astra‐Zeneca, Bristol‐Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi‐Aventis, and The Medicines Company. Dr. Bhatt has received royalties from Elsevier and has served as site co‐investigator for Biotronik, Boston Scientific, and St. Jude Medical. He has served as a trustee of the American College of Cardiology, and reports unfunded research with FlowCo, PLx Pharma, and Takeda.
Study Funding
This study was funded by Amarin Pharma, Inc.
Background/Synopsis
Residual cardiovascular (CV) risk persists in some patients despite optimal statin use and has been associated in part to elevated triglycerides (TG). Despite the fact that elevated TG represent an independent risk factor for CV events, CV outcomes studies of TG‐lowering therapies added to statins have not demonstrated benefit. Further, low‐dose omega‐3 CV outcome trials have demonstrated mixed results and no CV outcomes trial has yet been completed in patients prospectively selected based on elevated TG despite statin therapy. The omega‐3 fatty acid eicosapentaenoic acid (EPA) reduces TG without raising LDL‐C when administered in prescription‐strength doses. EPA has also been demonstrated to have potentially cardioprotective pleiotropic effects beyond TG lowering.
Objective/Purpose
The Reduction of Cardiovascular Events with Icosapent Ethyl‐Intervention Trial (REDUCE‐IT; NCT01492361) is examining whether icosapent ethyl (highly purified ethyl ester of EPA) reduces ischemic CV events in statin‐treated patients with high TG at elevated CV risk.
Methods
REDUCE‐IT is a phase 3b, multinational, double‐blind trial that randomized patients to prescription‐strength icosapent ethyl (4 g/day) or placebo control. REDUCE‐IT enrolled men or women age ≥45 years with established CV disease (approximately 70% of patients) or who were at high CV risk, defined as age ≥50 years with diabetes mellitus and ≥1 additional risk factor (approximately 30% of patients). Patients were required to have fasting TG ≥150 mg/dL and <500 mg/dL and LDL‐C >40 mg/dL and ≤100 mg/dL with stable statin (±ezetimibe) ≥4 weeks prior to qualifying measurements. The primary endpoint is a composite of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary endpoint is a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke. Several secondary, tertiary, and exploratory endpoints will also be assessed.
Results
Approximately 8,000 patients have been randomized at approximately 470 centers worldwide. Follow‐up will continue until approximately 1,612 adjudicated primary efficacy endpoint events occur.
Conclusions
REDUCE‐IT will address a long‐standing scientific gap by testing the effectiveness of icosapent ethyl to reduce CV events in patients with elevated TG and residual CV risk despite statin therapy.
128: OVERCOMING PRIOR AUTHORIZATION BARRIERS TO PCSK9 INHIBITORS WITH THE USE OF GENETICS†
Caroline F. deRichemond
Abstract Topic
Preventive Cardiology Best Practices ‐ clinic operations, team approaches, etc.
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Despite a recent American Heart Association consensus statement supporting Familial Hypercholesterolemia (FH) diagnosis in any patient with a LDL‐C >190 mg/dl and a positive family history, each insurance company still has its own policy for approval of Proprotein Convertase Subtilisin Kexin Type Nine (PCSK9) inhibitor therapy. Prior to consideration, all insurers require documentation of therapeutic lifestyle changes and maximization of statin, ezetimibe, and non‐statin therapies. Some insurers also require meeting Dutch Lipid Clinic, Simon Broome, or MEDPED criteria, which require genetic testing at a cost to the patient. The cost of PCSK9 inhibitor therapy alone is approximately $14,000 annually, and the majority of patients cannot afford the direct expense. Given the cost, providers must prescribe carefully and provide justification of therapy need.
Objective/Purpose
Will the addition of genetic testing as a diagnostic measure for FH remove barriers to insurance approval for PCSK9 inhibitor therapy?
Methods
A case series of four patients strongly suspected to have FH and unable to achieve LDL‐C goal. None of the patients had tendinous or cutaneous manifestations of FH. Two of the four patients had established coronary artery disease with intervention, one patient had evidence of subclinical atherosclerotic disease on CT scan, and one patient had no established subclinical or clinical coronary artery disease. All four patients were denied approval of PCSK9 inhibitor therapy by their insurance company because they did not meet the diagnostic criteria established by the insurer. Genetic testing was obtained through the Precision Genomic Center.
Results
All four patients had a positive return of FH with LDL‐R mutation. Following provider appeals, all four patients were approved for PCSK9 inhibitor therapy and achieved LDL‐C goal.
Conclusions
In the precision medicine era, preventative cardiology best practice may include genetic testing not only for clinical diagnosis, but also as a means to attain insurance approval for PCSK9 inhibitor therapy for appropriate patients.
129: HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA INHERITED FROM A SINGLE PARENT*
Simran Sidhu, Joel A. Casale, David Drossner, Robert Hegele, and Seth J. Baum
Abstract Topic
ASCVD in Special Populations
Lead Author'S Financial Disclosures
None
Study Funding
None
Background/Synopsis
Familial hypercholesterolemia (FH) is an autosomal dominant lipid disorder characterized by elevated LDL‐cholesterol and premature atherosclerotic cardiovascular disease. Homozygous FH (HoFH) is far rarer – and often more severe – than heterozygous FH (HeFH). Three genetic versions of HoFH exist including ‘double heterozygosity,’ the presence of mutations in two different genes each possessing large LDL‐C raising effects.
Objective/Purpose
We present the case of a 9‐year‐old boy (proband) presenting with high LDL‐C and markedly elevated lipoprotein. He is currently asymptomatic. He has a strong paternal family history of premature vascular disease. His father, of Irish, Italian, and Greek descent, had severe coronary artery disease by age 37; his paternal grandfather died from a myocardial infarction at 45, and the father'S paternal half‐sister has severe hypercholesterolemia. The remainder of the father'S family has been lost to follow‐up. The patient'S mother has normal lipids and denies a family history of vascular disease. Physical examination revealed no significant findings. Lipid panel demonstrated total cholesterol 253 mg/dL, LDL‐cholesterol 197 mg/dL, lipoprotein(a) 424 nmol/L. Genetic testing revealed one mutation in the APOB gene (G910C) and one mutation in the LDLR gene (G592E) in both proband and father. The proband'S four‐year‐old brother possesses the same APOB mutation (G910C). His LDL‐C is 108 mg/dL. The patient was treated with rosuvastatin 10 mg daily.
Methods
N/A
Results
In this case, the proband'S father possesses the FH phenotype, and the proband has the same double heterozygous mutations as his father. The proband and his father are by definition HoFH. The patient'S mother is normal. To our knowledge, this is the first report of HoFH inherited from a single parent with FH. Its ramifications are far reaching, impacting access to medications – mipomersen and lomitapide – as well as the clinical diagnosis of HoFH.
Conclusions
Physicians should understand the nuances in diagnosing HoFH. Continued use of criteria requiring FH in both parents to diagnose HoFH may leave some patients undiagnosed, and even expose them to an unnecessary risk of morbidity and mortality because of their failure to access appropriate HoFH therapies.