Benefit and risk of adding rivaroxaban in patients with coronary artery disease: A systematic review and meta-analysis
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Published on: February 28, 2012
Cheng Xie1, Yongfu Hang1, Jianguo Zhu1
1Department of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China.
Insights
Adding rivaroxaban to standard care in coronary artery disease (CAD) patients reduced major adverse cardiovascular events but increased bleeding risk. The benefit-risk balance varied significantly based on patient characteristics like age, sex, and comorbidities.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Rivaroxaban is approved for secondary prevention in myocardial infarction and stable coronary artery disease (CAD).
- However, its net clinical benefit in diverse CAD patient populations remains unclear.
- This meta-analysis specifically investigates treatment effects stratified by baseline clinical presentations.
Purpose of the Study:
- To evaluate the efficacy and safety of adding rivaroxaban for secondary prevention in CAD patients.
- To assess how baseline clinical characteristics influence the risk-benefit profile of rivaroxaban therapy.
Main Methods:
- Systematic literature search of Medline, EMBASE, and Cochrane Databases for randomized controlled trials (RCTs).
- Inclusion of 5 RCTs with 43,650 patients comparing rivaroxaban versus control in CAD.
- Primary efficacy and safety endpoints analyzed using Mantel-Haenszel pooled risk ratios (RRs) and 95% confidence intervals (CIs).
Main Results:
- Rivaroxaban significantly reduced the risk of major adverse cardiovascular events (RR, 0.86; 95% CI, 0.76-0.97).
- However, it significantly increased the risk of primary safety events, primarily bleeding (RR, 1.83; 95% CI, 1.10-3.05).
- Subgroup analyses indicated a more favorable risk-benefit ratio in males, but less favorable in older adults (≥65 years), females, diabetics, and patients with impaired renal function.
Conclusions:
- Rivaroxaban offers a potential additional therapeutic option for secondary prevention in coronary artery disease.
- Careful patient selection is crucial, considering individual risk factors for both ischemic and bleeding events.
- Achieving a net clinical benefit requires precise risk-benefit assessment based on patient characteristics.
Background:
Although the European Medicines Agency and the US Food and Drug Administration have, respectively, approved rivaroxaban for the prevention of recurrent major adverse cardiovascular events in patients with myocardial infarction and stable coronary artery disease, its efficacy and safety is unclear. This meta-analysis aimed to evaluate the benefit and risk of adding rivaroxaban in coronary artery disease (CAD) patients, focusing on treatment effects stratified by different baseline clinical presentations.
Hypothesis:
There are differences in treatment effects of adding rivaroxaban among CAD patients with different baseline clinical presentations.
Methods:
Medline, EMBASE, and Cochrane Databases were systematically searched from inception to 21 July 2020 for randomized controlled trials (RCTs) comparing rivaroxaban in CAD patients. The primary efficacy endpoint and safety endpoint were assessed by using Mantel-Haenszel pooled risk ratios (RRs) and 95% confidence intervals (CIs).
Results:
Five RCTs that included 43 650 patients were identified. Patients receiving rivaroxaban had a significantly lower risk of the primary efficacy endpoint (RR, 0.86; 95% CI, 0.76-0.97, p = .01) accompanied by increased risk of the primary safety endpoint (RR, 1.83; 95% CI, 1.10-3.05, p = .02). Subgroup analyses showed that in males the risk-benefit appears to be more favorable while in patients ≥65 years, in females, in patients with diabetes, those with mild to moderate impaired renal function, and region of Asia/other seems unfavorable.
Conclusion:
Rivaroxaban may provide an additional choice for secondary prevention in CAD patients. However, careful estimation of the risk of ischemic and bleeding events using patient characteristics are critical to achieving net benefit.
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