Abstract
Background:
We assess rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the ACC NCDR Peripheral Vascular Intervention (PVI) registry.
Methods:
Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index (DCI) score for patients’ zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Center for Medicare and Medicaid Services (CMS) data, we compared 1-year mortality, rates of amputation and repeat revascularizations.
Results:
Of 63,150 study cases 55,719 (88.2%) were performed in White patients and 7,431 (11.8%) in Black patients. Black patients were younger (67.9 vs 70.0 years), had higher rates of hypertension (94.4% vs 89.5%) diabetes (63.0% vs 46.2%), less likely to be able to walk 200 meters (29.1% vs 24.8%) and higher DCI scores (65.1 vs 50.6). Black patients were provided drug-eluting technologies at a higher rate adjusted odds ratio (aOR=1.14 [95% CI 1.06–1.23]) with no difference in atherectomy (aOR=0.98 [95% CI 0.91–1.05]) or intravascular imaging (aOR=1.03 [95% CI 0.88–1.22]) use. Black patients experienced a lower rate of acute kidney injury (aOR=0.79 [95% CI 0.72–0.88]). In CMS-linked analyses of 7,429 cases (11.8%) Black patients were significantly less likely to have surgical (adjusted hazard ratio (aHR) 0.40 [95% CI 0.17–0.96]) or repeat PVI revascularization (aHR 0.42 [95% CI 0.30–0.59]) at 1 year compared to White patients. There was no difference in mortality (aHR [0.8–1.4]) or major amputation aHR 2.5 [95% CI 0.8–7.6] between Black and White patients.
Conclusions:
Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.
Keywords: Peripheral Vascular Intervention
Subject terms: Peripheral Vascular Disease, Vascular Disease, Disparities
Graphical Abstract

Introduction
Peripheral artery disease (PAD) is a significant source of morbidity and mortality conferring a higher risk of major adverse cardiac events inclusive of myocardial infarction, ischemic stroke and cardiovascular death.1 The largest risk factors for development of PAD include: smoking, hypertension, hyperlipidemia, diabetes mellitus and chronic kidney disease. Medical management with antiplatelet agents, statins, structured exercise, anticoagulants and antihypertensives (if indicated) remain at the cornerstone of therapy. For patients that remain symptomatic despite guideline directed therapies, surgical and endovascular revascularization (including endovascular imaging guided angioplasty with or without stenting or atherectomy) are safe and can be used to provide symptom relief.2–7
The association between Black race and higher prevalence of peripheral artery disease has been well established.8–11 Among PAD patients, Black race is independently associated with a greater likelihood of undergoing lower extremity amputation compared with surgical revascularization.12–14 In the Vascular Quality Initiative registry, these racial disparities in amputation rates were confirmed and compounded by additional independent associations with care in rural versus urban settings.15
As race is not a biologic construct, elucidating the factors underpinning the described higher rates of adverse events among Black PAD patients requires a comprehensive examination of sociodemographic, comorbid, clinical, and healthcare delivery variables that may influence outcomes. Using data from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) registry, we sought to better understand two issues related specifically to potential racial disparities in patients undergoing PVI for PAD in the US. First, after accounting for sociodemographic community distress, comorbid conditions, clinical presentation and hospital characteristics, we aimed to evaluate whether the employment of “novel technologies” during PVI procedures (specifically drug-eluting technologies, atherectomy, and intravascular imaging) differed between Black and White patients. Second, among a subset of patients with available 1-year outcomes data, we assessed adjusted 1-year mortality, amputation, and repeat revascularization rates among Black and White patients.
Methods
Study Population
The ACC NCDR PVI registry, which collects patient, procedural and hospital characteristics has been previously described.16, 17 Waiver of written informed consent and authorization for this study was granted by the Advarra Institutional Review Board (IRB). The authors declare that all supporting data are available within the article and its online supplementary files.
For this study we included all consecutive adult patients at least 18 years of age who underwent lower extremity peripheral endovascular intervention between April, 1 2014 and March 31, 2019 in the United States captured in the NCDR PVI registry in a retrospective analysis. We excluded patients with reported race information neither Black nor White, patients with prior lower extremity bypass, lower extremity aneurysm, and those presenting with acute limb ischemia (Figure 1). The number of patients in the registry who were neither Black nor White was too low to derive conclusive results.
Figure 1.

Overall consort diagram for study cohort. A) Definition of study cohort; B) Definition of Center for Medicare and Medicaid Services linked study cohort
The PVI registry clinical report form includes detailed information on demographics, comorbid conditions, clinical presentation, lower extremity arterial anatomic characteristics, procedural characteristics, pre and post-procedure medication usage, and a variety of in-hospital outcomes.6 In order to more rigorously assess socioeconomic status, we additionally used 5 digit zip code to link a database containing the Distressed Community Index (DCI) score to the PVI registry. The DCI, developed by the Economic Innovation Group (EIG), is a proprietary zip code level composite of unemployment, education level, poverty rate, median income, business establishments, job growth, and housing vacancies that has been demonstrated to reliably characterize socioeconomic status and community distress in a variety of health services research efforts.Group18 DCI scores range from 0 to 100 with higher DCI scores indicating more community distress and lower socioeconomic status for residents of a zip code.
We specifically classified uses of “novel technologies” including drug-eluting technologies, atherectomy, and intravascular ultrasound in order to address raw and adjusted utilization rates between races. Additional in-hospital clinical outcomes derived from the PVI registry clinical report form included procedural success, major bleeding, present for urgent surgical revascularization, in-hospital major amputation, and mortality. Major adverse cardiovascular events (MACE) was defined as the composite of death, myocardial infarction and stroke, while major adverse limb events (MALE) was defined as the composite of major amputation, revascularization and acute limb ischemia. Major bleeding was defined as bleeding with a reduction in hemoglobin (Hb) of ≥3 g/dl, any Hb decline ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl.19 All data in the PVI registry clinical report form was entered by trained site-level abstractors. An annual sample of full medical charts was requested from sites each year for adjudication of data entry accuracy as has been described previously.6
In order to assess longer-term outcomes, we utilized an available dataset that was linked to Center for Medicare and Medicaid (CMS) Administrative Files using unique patient identifiers. CMS linkage was available for consecutive PVI registry patients that were discharged between January 1, 2015 and December 31, 2016 and participated in traditional Medicare Part A or B insurance plans. Among this subset of patients, we assessed raw and adjusted 1-year rates of major amputation, death, and repeat surgical or endovascular revascularization.
Statistical Analysis
We compared demographic, socioeconomic, comorbid, clinical presentation, anatomic, and hospital characteristics between Black and White patients with chi-square tests used for categorical covariates and t-tests used for continuous covariates.
The raw and inverse probability treatment weighting (IPTW)-adjusted use of “novel technologies” (defined above) as well as the in-hospital outcomes noted above were compared between Black and White patients. Candidate variables were selected a priori and included baseline demographics, pre-procedural comorbidities, clinical presentation details, intraprocedural information, and hospital characteristics. Specific modeled covariates were age, sex, body mass index (BMI), race, pre-procedure creatinine level, hypertension, diabetes mellitus, smoking status, prior myocardial infarction, prior transient ischemic attack, prior stroke, severe lung disease, prior PCI, prior coronary artery bypass graft (CABG), procedure duration, procedure indication (asymptomatic, claudication, CLI), procedure status (elective, urgent, emergent), procedure location (catheterization laboratory, hybrid operating room), sedation type (moderate sedation, general anesthesia), blood pressure, presence of superficial femoral artery/popliteal artery lesion, chronic total occlusion, number of patent runoff vessels, contrast volume, fluoroscopy time, US census region, number of beds, and teaching hospital status.
In the CMS-linked analysis, raw rates of 1-year mortality, amputation, and repeat surgical or endovascular revascularization were compared between Black and White patients. Inverse probability of treatment weighting-adjusted analyses were also performed for each of these endpoints with adjusted time-to-event curves derived for death and major amputation from competing risk models.
A p-value threshold of <0.05 was used to define statistical significance. All analyses were done using SAS version 9.4 (SAS Institute Inc, Cary, North Carolina). The Human Investigation Committee of the Yale University School of Medicine approved the use of the PVI Registry data for research purposes.
Results
In total, 73,085 procedures were recorded in the ACC NCDR PVI registry between April 1, 2014 and March 31, 2019. Procedures for which race was not identified as Black or White (n = 2,045), patients with prior lower extremity bypass (n = 5,158; 823 [16.0% Black]) as well as those with lower extremity aneurysm (n= 640) or presenting with acute limb ischemia (n= 2,092) were excluded from analysis. The remaining 66,604 procedures were included in the primary study cohort for analysis. (Figure 1)
Overall, 55,719 cases (88.2%) performed in White and 7,431 (11.8%) in Black patients. Black patients were younger (67.9 vs 70.0 years; p< 0.001), had higher rates of hypertension (94.4% vs 89.5%; p< 0.001), diabetes (63.0% vs 46.2%; p< 0.001), critical limb ischemia with rest pain (13.1% vs 7.3%; p< 0.001), critical limb ischemia with tissue loss (35.4% vs 17.5%; p< 0.001), were more likely to have maximum patient/provider reported walk distance under 200 meters (29.1% vs 24.8%; p< 0.001), were more likely to present for urgent procedures (24.6% vs 15.5%; p<0.001) and had higher DCI scores (65.1 vs 50.6; p< 0.001). Full details regarding baseline characteristics are provided in Table 1.
Table 1:
Baseline patient characteristics for study cohort.
| Description | Total | White | Black | P-value | |||
|---|---|---|---|---|---|---|---|
|
|
|||||||
| # | % | # | % | # | % | ||
|
|
|||||||
| ALL | 63150 | 100.0 | 55719 | 100.0 | 7431 | 100.0 | |
|
|
|||||||
| Demographics | |||||||
|
| |||||||
| Age: Mean (SD) | 69.8 | 10.5 | 70.1 | 10.4 | 67.9 | 11.4 | <0.001 |
|
|
|||||||
| Male | 37435 | 59.3 | 33699 | 60.5 | 3736 | 50.3 | <0.001 |
|
|
|||||||
| Health Insurance | <0.001 | ||||||
|
|
|||||||
| Medicare | 44111 | 69.9 | 39284 | 70.5 | 4827 | 654.0 | |
|
|
|||||||
| Medicaid | 3656 | 5.8 | 2961 | 5.3 | 695 | 9.4 | |
|
|
|||||||
| Private | 13323 | 21.1 | 11658 | 20.9 | 1665 | 22.4 | |
|
|
|||||||
| Other | 2060 | 3.3 | 1816 | 3.3 | 244 | 3.3 | |
|
|
|||||||
| Admit Source | <0.001 | ||||||
|
|
|||||||
| Emergency department | 8736 | 13.8 | 7377 | 13.2 | 1359 | 18.3 | |
|
|
|||||||
| Transfer in from another acute care facility | 2265 | 3.6 | 2020 | 3.6 | 245 | 3.3 | |
|
|
|||||||
| Elective | 49650 | 78.6 | 44141 | 79.2 | 5509 | 74.1 | |
|
|
|||||||
| Other | 2328 | 3.7 | 2023 | 3.6 | 305 | 4.1 | |
|
|
|||||||
| Missing | 171 | 0.3 | 158 | 0.3 | 13 | 0.2 | |
|
|
|||||||
| Distress Store | 52.3 | 27.9 | 50.6 | 27.7 | 65.1 | 26.1 | <0.001 |
|
|
|||||||
| Medical History | |||||||
|
| |||||||
| Body Mass Index: Mean (SD) | 29.7 | 48.0 | 29.8 | 48.5 | 29.4 | 44.2 | 0.537 |
|
|
|||||||
| Body Surface Area: Mean (SD) | 2.0 | 0.3 | 2.0 | 0.3 | 2.0 | 0.3 | 0.663 |
|
|
|||||||
| Tobacco Use | <0.001 | ||||||
|
|
|||||||
| Current | 21488 | 34.0 | 18949 | 34.0 | 2539 | 34.2 | |
|
|
|||||||
| Former | 25974 | 41.1 | 23257 | 41.7 | 2717 | 36.6 | |
|
|
|||||||
| Never | 15610 | 24.7 | 13443 | 24.1 | 2167 | 29.2 | |
|
|
|||||||
| Missing | 78 | 0.1 | 70 | 0.1 | 8 | 0.1 | |
|
|
|||||||
| Hypertension | 56906 | 90.1 | 49893 | 89.5 | 7013 | 94.4 | <0.001 |
|
|
|||||||
| Dyslipidemia | 52508 | 83.2 | 46571 | 83.6 | 5937 | 79.9 | <0.001 |
|
|
|||||||
| Diabetes | 30424 | 48.2 | 25741 | 46.2 | 4683 | 63.0 | <0.00 |
|
|
|||||||
| End-Stage Renal Disease on Dialysis | 3210 | 5.1 | 2052 | 3.7 | 1158 | 15.6 | <0.001 |
|
|
|||||||
| Coronary Artery Disease | 32058 | 50.8 | 28821 | 51.7 | 3237 | 43.6 | <0.001 |
|
|
|||||||
| Prior Cerebrovascular Disease | 10306 | 16.3 | 8579 | 15.4 | 1727 | 23.2 | <0.001 |
|
|
|||||||
| Cerebrovascular Disease: Stroke | 5184 | 8.2 | 4024 | 7.2 | 1160 | 15.6 | <0.001 |
|
|
|||||||
| Cerebrovascular Disease: Transient Ischemic Attack | 2388 | 3.8 | 2029 | 3.6 | 359 | 4.8 | <0.001 |
|
|
|||||||
| Cerebrovascular Disease: Carotid Stent | 846 | 1.3 | 765 | 1.4 | 81 | 1.1 | 0.046 |
|
|
|||||||
| Cerebrovascular Disease: Carotid Endarterectomy | 1997 | 3.2 | 1861 | 3.3 | 136 | 1.8 | <0.001 |
|
|
|||||||
| Prior Peripheral Artery Disease | 44771 | 70.9 | 38297 | 68.7 | 6474 | 87.1 | <0.001 |
|
|
|||||||
| Severe Lung Disease | 9717 | 15.4 | 8907 | 16.0 | 810 | 10.9 | <0.00 |
|
|
|||||||
| Prior Myocardial Infarction | 13563 | 21.5 | 12156 | 21.8 | 1407 | 18.9 | <0.001 |
|
|
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| Cardiomyopathy or Left Ventricular Systolic Dysfunction | 6305 | 10.0 | 5546 | 10.0 | 759 | 10.2 | <0.421 |
|
|
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| Prior Heart Failure | 10596 | 16.8 | 8902 | 16.0 | 1694 | 22.8 | <0.001 |
|
|
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| Prior Percutaneous Coronary Intervention | 16989 | 26.9 | 15255 | 27.4 | 1734 | 23.3 | <0.001 |
|
|
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| Prior Coronary Artery Bypass Graft | 13387 | 21.2 | 12431 | 22.3 | 956 | 12.9 | <0.001 |
|
|
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| Prior Valve Surgery/Procedure | 2255 | 3.6 | 2074 | 3.7 | 181 | 2.4 | <0.001 |
|
|
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| Family History of Premature Coronary Artery Disease | 6361 | 10.1 | 5824 | 10.5 | 537 | 7.2 | <0.001 |
|
|
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| Peripheral Arterial Disease Presentation (left or right) | |||||||
|
|
|||||||
| Asymptomatic | 16309 | 25.8 | 13829 | 24.8 | 2480 | 33.4 | <0.001 |
|
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| Atypical | 425 | 0.7 | 372 | 0.7 | 53 | 0.7 | 0.652 |
|
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| Chronic Limb Ischemia (Rutherford class 1–6) | 37865 | 60.0 | 31562 | 56.6 | 6303 | 84.8 | <0.001 |
|
|
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| Maximum Claudication Distance (left or right) | |||||||
|
|
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| <200m | 15982 | 25.3 | 13821 | 24.8 | 2161 | 29.1 | <0.001 |
|
|
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| >=200m (2 blocks) | 2769 | 4.4 | 2470 | 4.4 | 299 | 4.0 | 0.106 |
|
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| Unable to Walk | 226 | 0.4 | 195 | 0.4 | 31 | 0.4 | 0.362 |
|
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| Critical Limb Ischemia Rest Pain (left or right) | 5030 | 8.0 | 4059 | 7.3 | 971 | 13.1 | <0.001 |
|
|
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| Critical Limb Ischemia Tissue Loss (left or right) | 12407 | 19.7 | 9777 | 17.6 | 2630 | 35.4 | <0.001 |
|
|
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| Ankle-Brachial Index Performed (left or right) | 18427 | 29.2 | 15271 | 27.4 | 3156 | 42.5 | <0.001 |
|
|
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| Ankle-Brachial Index Value (Right): Mean (SD) | 0.7 | 0.3 | 0.7 | 0.3 | 0.7 | 0.3 | 0.002 |
|
|
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| Ankle-Brachial Index Value (Right): Mean (SD) | 0.7 | 0.3 | 0.7 | 0.3 | 0.7 | 0.3 | 0.0586 |
|
|
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| Ankle-Brachial Index Non-Compressible (left or right) | 2270 | 3.6 | 1740 | 3.1 | 530 | 7.1 | <0.001 |
|
|
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| Pre-procedure creatinine: Mean (SD) | 1.3 | 1.4 | 1.2 | 1.1 | 2.1 | 2.5 | <0.001 |
|
|
|||||||
| Low Density Lipoprotein: Mean (SD) | 89.2 | 42.8 | 89.1 | 42.8 | 89.87 | 42.7 | 0.6172 |
|
|
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| Procedure Information | |||||||
|
| |||||||
| Procedure Duration: Mean (SD) | 89.6 | 138.6 | 89.7 | 141.7 | 88.7 | 112.0 | 0.551 |
|
|
|||||||
| Lower Extremity Intervention Procedure Indication | <0.001 | ||||||
|
|
|||||||
| Typical Claudication | 19164 | 30.4 | 16647 | 29.9 | 2517 | 33.9 | |
|
|
|||||||
| Atypical Claudication | 1203 | 1.9 | 1033 | 1.9 | 170 | 2.3 | |
|
|
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| Critical Limb Ischemia | 17620 | 27.9 | 13986 | 25.1 | 3634 | 48.9 | |
|
|
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| Other | 153 | 0.2 | 126 | 0.2 | 27 | 0.4 | |
|
|
|||||||
| Unknown | 25010 | 39.6 | 23927 | 42.9 | 1083 | 14.6 | |
|
|
|||||||
| Procedure Status | <0.001 | ||||||
|
|
|||||||
| Elective | 51936 | 82.2 | 46370 | 83.2 | 5566 | 74.9 | |
|
|
|||||||
| Urgent | 10397 | 16.5 | 8612 | 15.5 | 1785 | 24.0 | |
|
|
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| Emergency | 794 | 1.3 | 716 | 1.3 | 78 | 1.1 | |
|
|
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| Missing | 23 | 0.0 | 21 | 0.0 | 2 | 0.0 | |
|
|
|||||||
| Procedure Location | <0.001 | ||||||
|
|
|||||||
| Catheterization Lab | 41792 | 66.2 | 35790 | 64.2 | 6002 | 80.8 | |
|
|
|||||||
| Interventional Radiology | 6750 | 10.7 | 6050 | 10.9 | 700 | 9.4 | |
|
|
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| Operating Room | 14579 | 23.1 | 13853 | 24.9 | 726 | 9.8 | |
|
|
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| Missing | 29 | 0.1 | 26 | 0.1 | 3 | 0.0 | |
|
|
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| Sedation | <0.001 | ||||||
|
|
|||||||
| Minimal Sedation Anxiolysis | 7876 | 12.5 | 7487 | 13.4 | 389 | 5.2 | |
|
|
|||||||
| Moderate Sedation/Analgesia (Conscious Sedation) | 39174 | 62.0 | 33156 | 59.5 | 6018 | 81.0 | |
|
|
|||||||
| Deep Sedation/Analgesia | 1052 | 1.7 | 856 | 1.5 | 196 | 2.6 | |
|
|
|||||||
| General Anesthesia | 14071 | 22.3 | 13305 | 23.9 | 766 | 10.3 | |
|
|
|||||||
| Missing | 977 | 1.6 | 915 | 1.6 | 62 | 0.8 | |
|
|
|||||||
| Systolic Blood pressure: Mean (SD) | 149.0 | 26.4 | 148.6 | 26.3 | 151.7 | 27.1 | <0.001 |
|
|
|||||||
| Diastolic Blood pressure: Mean (SD) | 75.9 | 14.2 | 75.4 | 14.0 | 79.7 | 14.9 | <0.001 |
|
|
|||||||
| Superficial Femoral Artery Lesion | 21950 | 34.8 | 18244 | 32.7 | 3706 | 49.9 | <0.001 |
|
|
|||||||
| Popliteal Artery Lesion | 10556 | 16.7 | 8709 | 15.6 | 1847 | 24.9 | <0.001 |
|
|
|||||||
| Number of patent runoff vessels | <0.001 | ||||||
|
|
|||||||
| 3 (#/%) | 10851 | 17.2 | 9651 | 17.3 | 1200 | 16.2 | |
|
|
|||||||
| 2 (#/%) | 8518 | 13.5 | 7081 | 12.7 | 1437 | 19.3 | |
|
|
|||||||
| 1 (#/%) | 6513 | 10.3 | 4971 | 8.9 | 1542 | 20.8 | |
|
|
|||||||
| None (#/%) | 1418 | 2.3 | 894 | 1.6 | 524 | 7.1 | |
|
|
|||||||
| Missing | 35850 | 56.8 | 33122 | 59.4 | 2728 | 36.7 | |
|
|
|||||||
| Dual Antiplatelet Therapy Candidate | 46659 | 73.9 | 41008 | 73.6 | 5651 | 76.1 | <0.001 |
|
|
|||||||
| Chronic Total Occlusion | 12171 | 19.3 | 9806 | 17.6 | 2365 | 31.8 | <0.001 |
|
|
|||||||
| Maximum Lesion length | 106.9 | 89.1 | 105.1 | 87.8 | 116.1 | 94.9 | <0.00100 |
|
|
|||||||
| Lower Extremity Lesion Treatment Incomplete or Aborted | 2493 | 4.0 | 1881 | 3.4 | 612 | 8.2 | <0.001 |
|
|
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| Contrast Volume: Mean (SD) | 127.0 | 76.0 | 126.9 | 76.6 | 127.8 | 71.9 | 0.34 |
|
|
|||||||
| Fluoroscopy Time: Mean (SD) | 19.4 | 20.7 | 19.3 | 21.1 | 19.96 | 17.85 | 0.0176 |
|
|
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| Hospital/Physician Information | |||||||
|
| |||||||
| United States Census Region | <0.001 | ||||||
|
|
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| Midwest Region | 22068 | 35.0 | 20050 | 36.0 | 2018 | 27.2 | |
|
|
|||||||
| Northeast Region | 3106 | 4.9 | 2894 | 5.2 | 212 | 2.9 | |
|
|
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| South Region | 31146 | 49.3 | 26121 | 46.9 | 5025 | 67.6 | |
|
|
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| West Region | 6772 | 10.7 | 6600 | 11.9 | 172 | 2.3 | |
|
|
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| Missing | 58 | 0.1 | 54 | 0.1 | 4 | 0.1 | |
|
|
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| Hospital Location | <0.001 | ||||||
|
|
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| Rural | 10531 | 16.7 | 10037 | 18.0 | 494 | 6.7 | |
|
|
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| Suburban | 27382 | 43.4 | 23089 | 41.5 | 4293 | 57.8 | |
|
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| Urban | 25237 | 40.0 | 22593 | 40.6 | 2644 | 35.6 | |
|
|
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| Participant Type | <0.001 | ||||||
|
|
|||||||
| Government | 328 | 0.5 | 315 | 0.6 | 13 | 0.2 | |
|
|
|||||||
| Private/Community | 61425 | 97.3 | 54356 | 97.6 | 7069 | 95.1 | |
|
|
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| University | 1397 | 2.2 | 1048 | 1.9 | 349 | 4.7 | |
|
|
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| Number of Certified Beds: Mean (SD) | 407.8 | 202.7 | 396.5 | 198.7 | 492.6 | 212.4 | <0.001 |
|
|
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| Peripheral Vascular Intervention annual volume: Mean (SD) | 291.6 | 246.0 | 274.8 | 229.9 | 417.2 | 316.6 | <0.001 |
|
|
|||||||
| Teaching | 28583 | 45.3 | 24858 | 44.6 | 3725 | 50.1 | <0.001 |
|
|
|||||||
| Public | 28230 | 44.7 | 24391 | 43.8 | 3839 | 51.7 | <0.001 |
|
|
|||||||
| Operator Annual Volume | 71.8 | 66.8 | 69.5 | 64.9 | 89.1 | 77.5 | <0.001 |
|
|
|||||||
SD- Standard deviation
Black patients were provided drug-eluting technologies at a higher rate than White patients adjusted odds ratio (aOR=1.14 [95% CI 1.06–1.23]) (Table 2) and had a lower rate of acute kidney injury aOR=0.79 [95% CI 0.72–0.88]. (Table 3) There was no difference in procedural success aOR= 1.00 [95% CI 0.89–1.22], use of intravascular imaging (aOR=1.03 [95% CI 0.88–1.22]), atherectomy (aOR=0.98 [95% CI 0.91–1.05]), major vascular complications aOR=1.09 [95% CI 0.95–1.26], or major bleeding aOR=0.90 [95% CI 0.79–1.04]. A full account of the effect of race on unadjusted and adjusted in-hospital outcomes are presented in supplemental table 1.
Table 2.
Association between Black Race and In-hospital Delivery of Novel Technologies
| Total (%) | White (%) | Black (%) | Unadjusted OR [95% CI] | Adjusted* OR [95% CI] | |
|---|---|---|---|---|---|
| Paclitaxel Drug Eluting Stent or Drug Coated Balloon | 15014 (23.8) | 12379 (22.2) | 2635 (35.5) | 2.66 [2.52–2.81] | 1.14 [1.06–1.23] |
| Intravascular imaging | 1433(2.3) | 1140 (2.1) | 293 (3.9) | 2.81 [2.43–3.24] | 1.03 [0.88–1.23] |
| Atherectomy | 12329 (19.5) | 10328 (18.5) | 2001 (25.9) | 0.88 [0.83–0.94] | 0.98 [0.91–1.05] |
Individual variables used to derive adjusted rates can be found in Table 1
CI-Confidence Interval; OR-Odds ratio
Table 3.
Association between Black Race and In-hospital Clinical Outcomes
| Total (%) | White (%) | Black (%) | Unadjusted OR [95% CI] | Adjusted* OR [95% CI] | |
|---|---|---|---|---|---|
| Procedural Success | 34666 (54.9) | 29150 (52.3) | 5516 (74.2) | 3.11 [2.98–3.25] | 1.00 [0.89–1.12] |
| In-Hospital Death | 1003 (1.6) | 899 (1.6) | 104 (1.4) | 1.74 [1.35–2.26] | 0.90 [0.68–1.21] |
| Major Adverse Cardiovascular Events | 369 (0.6) | 308 (0.6) | 61 (0.8) | 1.17 [1.00–1.36] | 1.11 [0.94–1.31] |
| Major Amputation (unplanned) | 113 (0.2) | 76 (0.1) | 37 (0.5) | 5.94 [3.60–9.80] | 1.48 [0.81–2.69] |
| Major Vascular Complication | 1746 (2.8) | 1387 (2.5) | 359 (4.8) | 2.56 [2.25–2.92] | 1.09 [0.95–1.26] |
| Major Bleeding Complication | 1792 (2.8) | 1639 (2.9) | 153 (2.1) | 0.98 [0.86–1.12] | 0.90 [0.79–1.04] |
| Acute Kidney Injury | 5821 (9.2) | 4745 (8.5) | 1076 (14.5) | 1.18 [1.09–1.28] | 0.79[0.72–0.88] |
Individual variables used to derive adjusted rates can be found in Table 1
CI-Confidence Interval; OR-Odds ratio
CMS-linked analysis
One-year analysis of patients with available CMS linkage (n = 7,429; 11.8% of the primary study cohort) revealed that Black patients had non-significantly higher adjusted hazard ratio (aHR) for death or major amputation (aHR=1.18 [95% CI 0.85–1.64]) (Figure 2) and major amputation alone (aHR=2.50 [95% CI 0.82–7.63]). Black patients were significantly less likely to have undergone surgical revascularization (aHR=0.41 [95% CI 0.17–0.97]) or PVI aHR=0.42 [95% CI 0.30–0.59] at 1-year compared to White patients. Black patients had lower rates of major adverse cardiovascular events (aHR=0.50 [95% CI 0.38–0.66]) and MALE (aHR=0.61 [95% CI 0.47–0.81]) at 1 year. For the CMS-linked cohort. effect of race on one-year outcomes, baseline patient characteristics, one-year outcomes by race and one-year event frequencies by race are depicted in supplemental tables S2–S5
Figures 2:

One-year Adjusted Rates of Clinical Outcomes Among Black and White Patients. A) Death; B) Major Amputation; C) Death or Major Amputation; D) One-year Surgical or Peripheral Vascular Intervention Revascularization
aHR= adjusted hazard ratio; PVI=Peripheral Vascular Intervention
Discussion
Among patients treated with endovascular lower extremity artery intervention in the NCDR PVI registry between 2014–2019, we found that Black patients were younger with higher rates of hypertension, hyperlipidemia, and diabetes mellitus than their White counterparts. Black patients also presented with, more clinical comorbidities, more severe initial clinical presentations and a higher symptom burden. There was slightly greater use of “novel” drug-eluting technologies but no difference in atherectomy or intravascular imaging use at index PVI revascularization procedures in Black patients. In-hospital procedural success and major vascular complication rates were similar between Black and White patients; however, Black patients were less likely to undergo both surgical revascularization or repeat PVI in the year after their incident PVI procedure. This finding is consistent with prior findings that Black patients were less likely to undergo revascularization procedures or admission for care of the afflicted extremity in an attempt at limb salvage in the two years prior to amputation.20
The importance of zip code level socioeconomic status- as captured by the DCI score, on morbidity and mortality outcomes is re-demonstrated in our study. Our study is the first to incorporate zip-code level assessment of socioeconomic status using the DCI score in a registry of patients post-PVI in order to disambiguate the race and socioeconomic status. The DCI score has been found to improve surgical risk adjustment, be associated with worse limb related outcomes after infrainguinal bypass and be predictive of risk-adjusted mortality after cardiac and bariatric surgeries.21–26
Our findings diverge from those previously reported by Loja et al who noted in their large single state study from 2005–2009 older than 35 years of age that Hispanic and Black patients had worse amputation-free survival than non-Hispanic White patients after PVI and significantly higher rates of re-intervention in the 12 months after PVI.13 The findings of similar usage rates of atherectomy, intravascular imaging and slightly higher implementation of novel drug eluting technologies suggest that incident care is similar between Black and White patients. This aligns with findings by Zaitoun et al that Black and White patients experience similar quality of health after PVI.27
The persistence of disparities in morbidity and mortality after PVI despite adjustment for demographics, community level socioeconomic status, patient demographics and hospital level factors demonstrate that reduction in racial disparities in PAD outcomes is unlikely to be primarily driven by care during acute hospitalizations or interventions. Aggressive risk factor modification, primary prevention, and access to continued cardiovascular preventive care may help narrow the gap in severity of disease at time of presentation observed between Black and White patients in our cohort as well as influence rates of amputation in the year post-procedure. It is unclear why Black patients undergo revascularization after PVI at lower rates than White patients. In addition, the associated trend toward a higher rate of major amputation seen in a prior study and confirmed in the present analysis remains concerning. It is possible that the effects of systemic racism- manifesting as disparities in socioeconomic status, lead to barriers in access to adequate outpatient care for PAD along with risk factor modification and can be a target for further intervention. A Barbershop-based PAD screening program for Black men revealed a higher than expected PAD prevalence and low PAD awareness.28 Further study is needed to elucidate the specific forces behind these findings.
Major amputation is associated with shorter survival time, increased risk of subsequent major amputation, and higher healthcare costs even after adjusting for demographics, medical history, and disease severity.29 The higher rates of major amputation among Black patients in this study may explain some of the excess mortality observed in this group.
Our study has several limitations. First, given the retrospective nature of the study design, the possibility of residual confounding cannot be completely eliminated. Limitations in availability of CMS linked data introduces uncertainty in the strength of conclusions derived from 1-year morbidity and mortality data. The number of non-Black, non-White patients in our registry was low and did not allow for robust comparison of racial groups aside from these. Our registry did not allow us to examine the effect of Hispanic ethnicity on the rates of co-morbid conditions and outcomes in question.
Conclusion
Black patients presenting for PVI were younger, had higher prevalence of comorbidities and critical limb ischemia, as well as residing in zip codes with lower socioeconomic status than White patients. Black patients had overall similar incident procedural PVI care and success compared to their White counterparts.
Supplementary Material
What is known
Peripheral artery disease (PAD) is a significant source of morbidity and mortality.
The prevalence of PAD is twice as high in Black Americans compared with non-Hispanic White Americans.
What the study adds
In this retrospective registry analysis, Black patients were provided drug eluting technologies more frequently that White patients.
In CMS linked analysis Black patients were less likely to have surgical or repeat PVI revascularization at 1 year.
Sources of Funding
This investigator-initiated study was supported by a grant from the National Cardiovascular Data Registry.
Disclosures
Dr. Julien discloses equity in Johnson and Johnson and Shockwave Medical stock.
Mr. Wang has no relevant financial disclosures pertinent to this work.
Dr. Curtis has an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the National Cardiovascular Data Registry; has received salary support from the American College of Cardiology and Centers for Medicaid & Medicare Services; and has equity in Medtronic.
Dr. Eberly has no relevant financial disclosures pertinent to this work.
Dr. Wang has no relevant financial disclosures pertinent to this work.
Dr. Johnston-Cox has no relevant financial disclosures pertinent to this work.
Dr. Nathan has no relevant financial disclosures pertinent to this work.
Dr. Fanaroff has reports a career development award from the American Heart Association,
research funding to his institution from Boston Scientific, and consulting fees from the
American Heart Association.
Dr. Khatana has received grant support from under National Heart, Lung, and Blood Institute (5K23 HL153772–02) and the American Heart Association (20CDA35320251).
Dr. Groeneveld has no relevant financial disclosures pertinent to this work.
Dr. Kobayashi has no relevant financial disclosures pertinent to this work.
Dr. Secemsky has Research grants to Beth Israel Deaconess Medical Center: NIH/National Heart Lung and Blood Institute K23HL150290, Harvard
Medical School’s Shore Faculty Development Award, AstraZeneca, Becton Dickinson, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips.
Consulting/Speaking: Abbott, Asahi, Bayer, BD, Boston Scientific, Cook, Cardiovascular Systems Incorporated, Inari, Janssen, Medtronic, Philips, and VentureMed.
Dr. Kohi has no relevant financial disclosures pertinent to this work.
Dr. Kirksey has no relevant financial disclosures pertinent to this work.
Dr. Eneanya has no relevant financial disclosures pertinent to this work.
Dr. Chery has no relevant financial disclosures pertinent to this work.
Dr. Vora has received education and research funding from Medtronic.
Dr. Armstrong has consulted for Abbott Vascular, Boston Scientific,
Cardiovascular Systems, Medtronic, and Spectranetics.
Dr. Jaff is employed on a part time basis by Boston Scientific and shareholder of Boston Scientific Corporation.
Dr. Giri has served on advisory boards for Astra Zeneca, Philips Medical, Boston Scientific and Inari Medical, and received research funds to the institution from St. Jude Medical, Boston Scientific, Inari Medical, and Recor Medical.
This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in this manuscript represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR.
Abbreviations and Acronyms
- ACC
American College of Cardiology
- PVI
Peripheral vascular Intervention
- CMS
Center for Medicare and Medicaid Services
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