Abstract
Background:
In Vietnam, there has been no survey conducted on the prescribing and monitoring practices of oral anticoagulants to ensure that patients with atrial fibrillation receive appropriate. Objective: Therefore, we conducted this research to clarify the aforementioned issue in our hospital.
Methods:
We carried out a cross-sectional study by reviewing outpatient electronic medical records at the University Medical Center in Ho Chi Minh City. Our study included 1087 patients aged 18 years or older diagnosed with non-valvular atrial fibrillation (NVAF), who visited the Cardiology clinic between January 1st, 2021, and June 30th, 2021.
Results:
Among the 1087 patients with non-valvular atrial fibrillation (NVAF), 1036 were eligible for anticoagulant therapy. However, only 847 (81.8%) received prescriptions for either Vitamin K antagonists (VKAs) (n=129, 15.2%) or Non-Vitamin K antagonist oral anticoagulants (NOACs) (n=718, 84.8%). NOAC prescriptions were more commonly found in patients aged 75 or older (adjusted odds ratio [OR]=2), those with health insurance coverage (adjusted OR=2.9), and in individuals with a history of hypertension (adjusted OR=2). On the contrary, patients with a farming occupation were less likely to be prescribed NOACs (adjusted OR=0.4). About 75% of patients adhered to the guidelines recommending close monitoring during anticoagulant treatment. Notably, inappropriate prescriptions were identified in 27.7% of cases, especially among those with no recorded body weight (which is necessary for precise dosing based on creatinine clearance), those without health insurance, those with undocumented CHA2DS2-VASc scores, or those who were concurrently using antiplatelet agents.
Conclusion:
A discrepancy persists between clinical guidelines and the actual practice in diagnosing and managing patients with non-valvular atrial fibrillation (NVAF). It is crucial to prioritize the regular reevaluation of thromboembolic risk scores at follow-up appointments, ensure strict adherence to clinical monitoring standards, and align anticoagulant medication prescriptions with established guidelines.
Keywords: Oral anticoagulant, non-valvular atrial fibrillation, prescribing, monitoring
1. BACKGROUND
The incidence of atrial fibrillation (AF) is escalating rapidly worldwide. In the Asia-Pacific region, the prevalence of AF varies from 0.49% to 5.4%, with the rate of AF-related hospitalizations having quadrupled over the past decade (1). Anticoagulants are essential for stroke prevention in patients with AF, yet there remains a significant delay in prescribing oral anticoagulants to patients for whom they are indicated (2). Factors contributing to this delay in the non-prescription group include female gender, absence of hypertension, history of falls, and chronic kidney disease (2). However, the ESC 2020 guidelines for AF management highlight the importance of basing anticoagulation on stroke risk assessment, irrespective of the type of atrial fibrillation or the risk of bleeding (3). The calculation of bleeding risk scores is crucial for physicians to identify and mitigate existing risk factors, which helps reduce the incidence of bleeding complications, rather than avoiding anticoagulant therapy altogether. The JACC: Asia Statement recommends reassessing stroke and bleeding risk scores at every follow-up appointment, or at a minimum, annually (4).
Non-vitamin K oral anticoagulants (NOACs) offer multiple benefits over vitamin K antagonists, including ease of use, less need for monitoring, better prevention of stroke, lower risk of severe bleeding, and a 10% reduction in overall mortality (5). Factors favoring the selection of NOACs include a lower risk of stroke and bleeding, adequate renal function, patient management with a rhythm control strategy, and favorable socioeconomic status. However, the literature indicates a troubling issue: up to 39% of patients are prescribed NOACs at doses not aligned with their renal function. Furthermore, a significant proportion, 37%, do not receive baseline creatinine tests when starting anticoagulant treatment, which is essential for appropriate dosing.
In Vietnam, while numerous studies have focused on the prevalence of anticoagulant use in patients with non-valvular atrial fibrillation (AF), few have delved into the clinical application of anticoagulant therapy within this patient group.
2. OBJECTIVE
To bridge this knowledge gap, our study was conducted with the objective of evaluating the use of anticoagulant medications among patients with non-valvular AF at cardiovascular clinics.
3. MATERIAL AND METHODS
We conducted a descriptive cross-sectional study at the Cardiology Clinic of the University Medical Center in Ho Chi Minh City, targeting patients 18 years and older who presented between January 1st, 2021, and June 30th, 2021. We included those diagnosed with non-valvular atrial fibrillation (AF) – defined as AF not associated with a mechanical valve replacement or a recent bioprosthetic valve replacement within the past three months, nor with moderate-to-severe mitral stenosis. Exclusion criteria were patients with incomplete electronic medical records that precluded the evaluation of prescription appropriateness (e.g., missing data on out-of-hospital testing), patients with other indications for anticoagulation (e.g., pulmonary embolism), or those diagnosed with paroxysmal AF attributable to causes that had been successfully treated (e.g., acute coronary syndrome, infection, hyperthyroidism, post-surgery), who also showed no atrial structural abnormalities on echocardiography and no recurrence of atrial fibrillation on Holter ECG monitoring.
To assess thromboembolic risk, we utilized the CHA2DS2-VASc score, which assigns 1 point each for congestive heart failure, hypertension, age ≥65 years (and 2 points for age ≥75 years), diabetes mellitus, female sex, and coronary or peripheral arterial disease, and 2 points for a history of stroke or transient ischemic attack.
Anticoagulation prescriptions were categorized as inappropriate under two conditions: first, if patients met the criteria for anticoagulation therapy according to Class IA of the ESC 2020 guidelines but were not on therapy without a documented justification; and second, if they were on anticoagulation therapy but at dosages not aligned with the guidelines (3). Additionally, prescribing anticoagulants to patients without an indication for therapy (CHA2DS2-VASc score of 0 in males or ≤1 in females) was also considered inappropriate. Regarding the dosing of Rivaroxaban, we referred to the J-Rocket AF study from Japan. This study suggested a dose of 15mg for estimated creatinine clearance ≥ 50 ml/min, and 10mg for clearance <50 ml/min (6).
In the case of very elderly patients (aged 80 years or older), the decision to forgo anticoagulation can be justified if they present a high risk of bleeding. This risk includes factors such as severe renal impairment (creatinine clearance between 15-30 mL/min), a history of significant bleeding, low body weight (≤45 kg), or the concurrent use of antiplatelet agents or nonsteroidal anti-inflammatory drugs (NSAIDs). This approach aligns with the findings from the ELDERCARE-AF study (7).
Patients were recommended to receive appropriate clinical monitoring, which should include assessments of renal function, liver function, and a complete blood count. These tests should be conducted annually if the patient has normal renal and liver function. However, for those with impaired renal or liver function, these tests should be carried out every six months (3). Patients who failed to adhere to these monitoring guidelines were considered to be inadequately monitored.
The demographic and clinical characteristics of the study participants were summarized as follows: for continuous variables, we used the mean ± standard deviation (SD) or the median and interquartile range (IQR), depending on the distribution of the data. For categorical variables, we reported frequencies and percentages. To assess the differences in these characteristics, T-tests were applied to continuous variables, while χ2 (Chi-square) tests or Fisher's exact tests were used for categorical variables.
To investigate the independent associations between patient demographics and the selection of antithrombotic therapy, binary logistic regression models were employed. All statistical tests were two-sided, and a p-value of less than 0.05 was considered indicative of statistical significance. The analyses were carried out using SPSS software, version 22.0.
4. RESULTS
Our study involved data collection from 1087 patients, of which 51 cases were identified as having no indication for anticoagulant therapy (Class III), representing 4.7% of the total. Subsequent analyses primarily focused on the subgroup of 1036 patients who were identified as having an indication for anticoagulant therapy.
The demographic and clinical characteristics, along with anticoagulant prescriptions, of the 1036 patients with atrial fibrillation included in the study at the time of the survey are summarized in Table 1 and Table 2 of the entire cohort.
Table 1. Differences between NOAC vs Antivitamin K.
| NOAC n=718 |
Antivitamin K n=129 |
Crude OR (95% CI) | Multivariable adjusted (95% CI) | |
|---|---|---|---|---|
| Sex | ||||
| Male | 340 (47.4%) | 64 (49.6%) | 1 | - |
| Female | 378 (52.6%) | 65 (50.4%) | 1.1 (0.8-1.6) | - |
| Age | ||||
| Mean ± SD | 73 ± 11,5 | 68 ± 11 | ||
| < 65 | 157 (21.9%) | 48 (37.2%) | 1 | 1 |
| 65 -74 | 221 (30.7%) | 46 (35.7%) | 1.5(0.9-2.3) | 1.4 (0.8-2.3) |
| >= 75 | 340 (47.4%) | 35 (27.1%) | 3 (1.8-4.8) | 2 (1.1-3.6) |
| Region | ||||
| Rural area | 306 (42.6%) | 75 (58.1%) | 1 | 1 |
| Urban outside HCM city | 178 (24.8%) | 20 (15.5%) | 1.7(1.1-2.6) | 1.3 (0.8-2.1) |
| HCM city | 234 (32.6%) | 34 (26.4%) | 2.1(1.3-3.7) | 1.7 (0.9-3) |
| Occupation | ||||
| Not working | 236 (32.9%) | 21 (16.3%) | 1 | 1 |
| Farmer | 84 (11.6%) | 39 (30.2%) | 0.2(0.1-0.3) | 0.4 (0.2-0.8) |
| Retired | 117 (16.3%) | 11 (8.5%) | 0.9 (0.4-2) | 1.1 (0.5-2.3) |
| Housewife | 132 (18.4%) | 28 (21.7%) | 0.4(0.2-0.76) | 0.6 (0.3-1.2) |
| Freelance | 149 (20.8%) | 30 (23.3%) | 0.4(0.2-0.8) | 0.8 (0.4-1.7) |
| Healthcare insurrance | ||||
| No | 337 (46.9%) | 99 (76.7%) | 1 | 1 |
| Yes | 381 (53.1%) | 30 (23.3%) | 3.7(2.4-5.8) | 2.9 (1.8-4.6) |
| Heart failure | ||||
| No | 493 (68.7%) | 80 (62%) | 1 | - |
| Yes | 225 (31.3%) | 49 (38%) | 0.7 (0.5-1.1) | - |
| Hypertension | ||||
| No | 108 (15%) | 41 (31.8%) | 1 | 1 |
| Yes | 610 (85%) | 88 (68.2%) | 2.6 (1.7-4) | 2 (1.2-3.1) |
| Diabetes | ||||
| No | 476 (66.3%) | 92 (71.3%) | 1 | - |
| Yes | 242 (33.7%) | 37 (28.7%) | 1.3 (0.8-1.9) | - |
| Stroke | ||||
| No | 544 (75.8%) | 105 (81.4%) | 1 | - |
| Yes | 174 (24.2%) | 24 (18.6%) | 1.4 (0.9-2.3) | - |
| TIA | ||||
| No | 710 (98.9%) | 129 (100%) | - | - |
| Yes | 8 (1.1%) | 0 | - | - |
| Chronic renal disease | ||||
| No | 505 (70.3%) | 90 (69.8%) | 1 | - |
| Yes | 213 (29.7%) | 39 (30.2%) | 0.9 (0.6-1.5) | - |
| Cirrhosis | ||||
| No | 707 (98.5%) | 124 (96.1%) | 1 | - |
| Yes | 11 (1.5%) | 5 (3.9%) | 0.4 (0.1-1.1) | - |
| History of hemorrhage | ||||
| No | 645 (89.8%) | 117 (90.7%) | 1 | - |
| Yes | 73 (10.2%) | 12 (9.3%) | 1.1 (0.6-2.1) | - |
| CHA2DS2-VASc review | ||||
| Median (range) | 4 (3-6) | 4(2-5) | ||
| No | 274 (38.2%) | 81 (62.8%) | 1 | 1 |
| Yes | 444 (61.8%) | 48 (37.2%) | 2.7 (1.9-4) | 2.2 (1.5-3.4) |
Table 2. Differences between anticoagulant use and not anticoagulant using.
| Anticoagulant use n=847 | No anticogulant drug n=189 | Crude OR (95% CI) | Multivariable adjusted (95% CI) | |
|---|---|---|---|---|
| Sex | ||||
| Male | 404 (47.7%) | 90 (47.6%) | 1 | - |
| Female | 443 (52.3%) | 99 (52.4%) | 0.9 (0.7-1.4) | - |
| Age | ||||
| Mean ± SD | 72.2 ± 11.5 | 70.5 ± 13.8 | ||
| < 65 | 205 (24.2%) | 63 (33.3%) | 1 | 1 |
| 65 - 74 | 267 (31.5%) | 44 (23.3%) | 1.7 (1.2-2.9) | 1.8 (1.1-2.8) |
| >= 75 | 375 (44.3%) | 82 (43.4%) | 1.4 (0.9-2) | 1.2 (0.8-1.8) |
| Region | ||||
| Rural area | 381 (45%) | 82 (43.4%) | 1 | - |
| Urban outside HMC city | 198 (23.4%) | 52 (27.5%) | 1.1 (0.7-1.5) | - |
| HCM city | 268 (31,6%) | 55 (29,1%) | 0.8 (0.6-1.2) | - |
| Occupation | ||||
| Not working | 257 (30.4%) | 61 (32.3%) | 1 | - |
| Farmer | 123 (14.5%) | 26 (13.8%) | 1.1 (0.7-1.9) | - |
| Retired | 128 (15.1%) | 25 (13.2%) | 1.2 (0.7-2) | - |
| Housewife | 160 (18.9%) | 28 (14.8%) | 1.4 (0.8-2.2) | - |
| Freelance | 179 (21.1%) | 49 (25.9%) | 0.9 (0.6-1.3) | - |
| Healthcare insurrance | ||||
| No | 436 (51.5%) | 128 (67.7%) | 1 | 1 |
| Yes | 411 (48.5%) | 61 (32.3%) | 2 (1.4-2.8) | 1.9 (1.4-2.8) |
| Heart failure | ||||
| No | 573 (67.7%) | 137 (72.5%) | 1 | - |
| Yes | 274 (32.3%) | 52 (27.5%) | 1.3 (0.9-1.8) | - |
| Hypertension | ||||
| No | 149 (17.6%) | 49 (25.9%) | 1 | 1 |
| Yes | 698 (82.4%) | 140 (74.1%) | 1.6(1.1-2.4) | 1.3 (0.9-2) |
| Diabetes | ||||
| No | 568 (67.1%) | 147 (77.8%) | 1 | 1 |
| Yes | 279 (32.9%) | 42 (22.2%) | 1.7(1.2-2.5) | 1.5 (1.1-2.3) |
| Stroke | ||||
| No | 649 (76,6%) | 168 (88,9%) | 1 | 1 |
| Yes | 198 (23,4%) | 21 (11,1%) | 2.4(1.5-3.9) | 2.8 (1.7-4.6) |
| TIA | ||||
| No | 839 (99.1%) | 189 (100%) | - | - |
| Yes | 8 (0.9%) | 0 | - | - |
| Chronic renal disease | ||||
| No | 594 (70.2%) | 141 (74.6%) | 1 | - |
| Yes | 252 (29.8%) | 48 (25.4%) | 1.2(0.9-1.8) | - |
| Cirrhosis | ||||
| No | 831 (98.1%) | 179 (94.7%) | 1 | 1 |
| Yes | 16 (1.9%) | 10 (5.3%) | 0.3(0.2-0.8) | 0.3 (0.1-0.6) |
| History of hemorrhage | ||||
| No | 762 (90%) | 147 (77.8%) | 1 | 1 |
| Yes | 85 (10%) | 42 (22.2%) | 0.4(0.3-0.6) | 0.3 (0.2-0.4) |
| CHA2DS2VAS review | ||||
| Median (range) | 4 (3-6) | 4 (2-5)* | ||
| No | 355 (41.9%) | 115 (60.8%) | 1 | 1 |
| Yes | 492 (58.1%) | 74 (39.2%) | 2.2 (1.6-3) | 2.2 (1.6-3.1) |
In our study, there were no significant differences in gender, place of residence, or occupation between patients who were and were not using anticoagulation therapy. As indicated in Table 1, patients aged between 65 and 74 were more likely to be prescribed anticoagulants compared to other age groups. Health insurance emerged as a significant factor in the prescription of anticoagulants (OR 1.9; 95% CI: 1.4–2.8) and in the preference for NOACs over vitamin K antagonists (OR 2.9; 95% CI: 1.8–4.6). Patients with evaluated CHA2DS2-VASc scores were more frequently prescribed anticoagulants than those without such evaluations. However, the data from electronic medical records revealed that the proportion of patients assessed for CHA2DS2-VASc and HAS-BLED scores was relatively low (54% and 25.1%, respectively). Comorbidities such as hypertension, heart failure, diabetes, and cerebral infarction were associated with an increased likelihood of anticoagulant prescription. Conversely, a history of bleeding or cirrhosis was linked to discontinuation of anticoagulant drugs. Notably, patients aged 75 and above, as well as those with health insurance, were more inclined to receive NOAC prescriptions.
Table 3 summarizes the laboratory values for AST/ALT, hemoglobin, and serum creatinine (SCr). During the course of treatment, a significant number of patients did not receive the recommended checks for AST or ALT (67.7%), hemoglobin (18%), and SCr (17%). For those patients who had laboratory data collected at the time of survey, the majority of the results fell within the normal range. Notably, among the patients treated with NOACs, 182 were prescribed doses that were inappropriate considering their baseline SCr levels and body weight.
Table 3. Laboratory data obtained of the time of survey.
| Within normal limit | Abnormal | Unavailable | |
|---|---|---|---|
| AST/ALT | 827 | 62 | 147 (67.7%) |
| Heamoglobin | 740 | 257 | 39 (18%) |
| Serum creatinin | N/A | N/A | 37 (17%) |
5. DISCUSSION
While Asian patients are often prescribed lower doses of NOACs compared to their non-Asian counterparts, the latest statement from the Journal of the American College of Cardiology (JACC) regarding Stroke Prevention in Atrial Fibrillation in Asia presents strong evidence in favor of adhering to guideline-directed anticoagulation practices (4).
This study, to our knowledge, is the most extensive in Vietnam to date, offering a comprehensive assessment of the use of oral anticoagulant medications in outpatient settings for patients with non-valvular atrial fibrillation. A key finding of this observational research was the influence of various sociodemographic factors on the choice between NOACs and vitamin K antagonists in treating atrial fibrillation patients. Additionally, we noted a correlation between these sociodemographic characteristics and the overall use of anticoagulants. Despite the prevalence of atrial fibrillation and the existence of numerous guidelines for its management, a considerable discrepancy persists between these guidelines and actual clinical practice.
Among the 51 cases we identified as having no indication for anticoagulant therapy, 31 (60.8%) were appropriately not prescribed anticoagulants. However, the remaining prescriptions were considered inappropriate: 12 cases were inappropriately prescribed anticoagulants, and 8 cases were prescribed antiplatelet agents without any other indication for such therapy. These instances of inappropriate prescribing might be attributed to physicians' concerns about potential adverse events, particularly as all these patients were young.
In multivariate analysis, older age, healthcare insurance available and CHA2DS2-VASc evaluation were associated with an increase in likelihood of starting treatment with NOACs instead of antivitamin K. People over the age of 75 often have a higher risk of stroke due to the accumulation of risk factors such as age, cardiovascular disease, history of stroke, and other medical conditions. The CHA2DS2-VASc stroke risk assessment system typically assigns points for factors such as age, gender, history of heart disease, history of stroke, history of diabetes, and several other factors. Individuals over 75 usually score higher on the CHA2DS2-VASc, indicating a higher risk of stroke, and the use of anticoagulants may be considered to reduce this risk. This was similar to the research conducted by Luisa Ibáñez and colleagues (8). When physicians assessed the CHA2DS2-VASc score, they payed attention to the patient's stroke risk and tended to prescribe anticoagulants more often, frequently choosing NOACs because users did not need to adhere to a strict diet to maintain stable drug levels, nor did they need regular blood tests to monitor drug concentrations like with Vitamin K antagonists. This made treatment adherence easier for patients, as those who visited our hospital often came from far away, incurring significant travel time, and usually prefered to prolong the interval between appointments. Health insurance was also an important factor for patients being prescribed NOACs, as the cost of anticoagulant medication could be a financial burden for the Vietnamese people without the support of health insurance.
Studies worldwide have concentrated on the relationship between the CHA2DS2-VASc score and stroke incidence in patients with non-valvular atrial fibrillation. However, these studies often overlook the actual percentage of patients who are evaluated using this scoring system in clinical practice. Our survey revealed that nearly half of the prescriptions did not include a CHA2DS2-VASc evaluation. This significant omission in practice could lead to a higher incidence of inappropriate medication prescriptions in this group, especially compared to patients who have undergone a risk stratification assessment.
In this study, 81.8% of patients with indications were on anticoagulant therapy, a rate that is nearly consistent with other real-life studies. Among those on NOACs, 54.5% were prescribed Rivaroxaban, and 29.9% were on Dabigatran. At this time (2021), only a few patients were prescribed Apixaban and Edoxaban due to their unavailability in Vietnam. Vitamin K antagonists were used in about 15.1% of the cases. This cohort study reflects a gradual transition towards the use of DOACs at our hospital, aligning with the global trend.
Nearly half of the patients in our study were from rural areas. However, we did not observe a significant difference in the use of anticoagulants between urban and rural patients. This contrasts with findings from research by Gurusamy in Sweden, which indicated that rural patients were only half as likely to initiate treatment with a NOAC as those in urban areas (9). A possible explanation for this discrepancy is that our study was conducted at a single center in Ho Chi Minh City. Consequently, the sample size was limited, and most patients from outside the city who sought treatment generally had better economic conditions and awareness about their health. This may have influenced the comparable rates of anticoagulant use between urban and rural patients in our study.
Our study found no significant difference in the use of anticoagulants among various professions, suggesting that factors like education level or income do not heavily influence the decision to use anticoagulants. Instead, this decision appears to rely more on the treating physician's judgement. Notably, within the farming profession, there was a lower usage of NOACs compared to other professional groups. This trend might be attributed to income disparities. However, it is important to note that most patients treated at our hospital, regardless of their profession, likely possess sufficient economic means.
Clinical doctors at UMC often choose to reduce the dosage of anticoagulant medications, with about 63.7% of adjustments based on the results of the J-ROCKET study, primarily due to concerns about bleeding complications. However, we did not find a direct correlation between HAS-BLED scores and the use of anticoagulants; only 25% of the patients were evaluated with HAS-BLED scores, a relatively low proportion.
Furthermore, our data shows that 59.7% of the patients were closely monitored following the ESC (European Society of Cardiology) guidelines, a rate that is quite commendable in comparison to the findings of Simon and colleagues' study in 2015 (10). We are committed to enhancing the quality of treatment and will continue to closely monitor our patients.
6. CONCLUSION
Our study provides a partial overview of the treatment landscape for patients with non-valvular atrial fibrillation in Vietnam. There are evident gaps in the patient assessment process that need to be addressed to enhance the quality of care. Ensuring extensive coverage through the health insurance system is crucial to facilitate better medical treatment and to prevent disparities between insured and uninsured individuals. Additionally, the regular updating of specific treatment guidelines for patients with non-valvular atrial fibrillation is imperative for advancing treatment standards. These measures are vital for improving the quality of care for patients with NVAF.
Acknowledgments:
All contributors to the manuscript other than co-authorships should be acknowledgement.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent forms.
Author’s contribution:
All authors gave a substantial contribution to the conception, design of the work, contribution of data, contribution to the acquisition, analysis, or interpretation of data for the work, and article preparing for drafting or revising it critically for important intellectual content. All authors gave final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Conflicts of interest:
The authors declare no conflicts of interest.
Financial support and sponsorship:
Nil.
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