Key result
Low-dose rivaroxaban plus antiplatelets cuts CV events ~14% versus antiplatelets alone but increases major bleeding.
Why the study?
The study aimed to review evidence on the effectiveness and safety of low-dose rivaroxaban 2.5 mg twice daily in patients with CAD and/or PAD taking antiplatelets.
Does low-dose rivaroxaban added to antiplatelet therapy reduce cardiovascular events in patients with CAD and/or PAD?
Meta-Analysis (n=45,836)
Does low-dose rivaroxaban added to antiplatelet therapy reduce cardiovascular events in patients with CAD and/or PAD?
Effect estimate: HR 0.86 (95% CI 0.78-0.94)
Low-dose rivaroxaban combined with antiplatelet therapy provides a favorable net clinical benefit by reducing cardiovascular events and ischemic stroke in CAD/PAD patients, despite an increased risk of major bleeding.
Supports adding low-dose rivaroxaban to antiplatelets in CAD/PAD; confirms net clinical benefit in meta-analysis.
Objectives: To review the evidence on the effectiveness and safety of low-dose-rivaroxaban 2.5 mg twice daily (LDR) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) taking antiplatelets. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Efficacy endpoints were cardiovascular events (CVEs), myocardial infarction, stroke, all-cause, and cardiovascular death. Any, major, fatal bleeding, and intracranial hemorrhage (ICH) were safety endpoints. Numbers needed to treat (NNT), and numbers needed to harm (NNH) were also calculated. Results: Seven RCTs were included with 45,836 patients: 34,276 with CAD and 11,560 with PAD. Overall, 4247 CVEs and 3082 bleedings were registered. LDR in association with either any antiplatelet drug or aspirin (ASA) alone reduced the risk of CVEs (hazard ratio [HR] 0.86, 95% confidence interval [95%CI] 0.78–0.94) and ischemic stroke (HR 0.68, 95%CI 0.55–0.84). LDR + ASA increased the risk of major bleeding (HR 1.71, 95%CI 1.38–2.11) but no excess of fatal bleeding or ICH was found. The NNT to prevent one CVE for LDR + ASA was 63 (43–103) and the NNH to cause major bleeding was 107 (77–193). Conclusions: The combination of LDR with either antiplatelet drugs or low-dose aspirin reduces CVEs and ischemic stroke in patients with CAD/PAD. There was an increased risk of major bleeding but no excess of fatal or ICH was found. LDR seems to have a favorable net clinical benefit compared to ASA treatment alone.
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Bucci et al. (2024) conducted a meta-analysis in Coronary artery disease (CAD) and/or peripheral artery disease (PAD) (n=45,836). Low-dose rivaroxaban vs. Antiplatelet drug or aspirin alone was evaluated on Cardiovascular events (CVEs) (HR 0.86, 95% CI 0.78-0.94). Low-dose rivaroxaban combined with antiplatelets reduced cardiovascular events (HR 0.86; 95% CI 0.78-0.94) but increased major bleeding (HR 1.71; 95% CI 1.38-2.11) versus antiplatelets alone.
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