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Antiplatelets for Cardiovascular Disease in Non-valvular AF with Rivaroxaban: A Subanalysis of the EXPAND Study
Koichi Kaikita1,2, Shinichiro Uchiyama3, Hirotsugu Atarashi4,5
1Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki.
Insights
Rivaroxaban plus antiplatelet therapy (APT) did not improve ischemic outcomes for patients with non-valvular atrial fibrillation (NVAF) and coronary artery disease (CAD) or stroke. However, this combination therapy increased bleeding risks in these patient groups.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Non-valvular atrial fibrillation (NVAF) often coexists with stable coronary artery disease (CAD), ischemic stroke, or peripheral artery disease (PAD).
- Optimal antithrombotic strategies for patients with NVAF and these comorbidities are crucial for balancing efficacy and safety.
Purpose of the Study:
- To evaluate the risks and benefits of rivaroxaban plus antiplatelet therapy (APT) versus rivaroxaban alone in patients with NVAF complicated by stable CAD, ischemic stroke, or PAD.
- To assess the impact of adding APT on ischemic outcomes and bleeding events.
Main Methods:
- Subanalysis of the EXPAND study involving 2,030 patients with NVAF and CAD, ischemic stroke, or PAD.
- Patients received rivaroxaban (10 or 15 mg/day) with or without APT.
- Efficacy outcomes included symptomatic stroke, systemic embolism, myocardial infarction, and cardiovascular death. Safety outcomes comprised major and any bleeding events.
Main Results:
- No significant differences in efficacy outcomes were observed between rivaroxaban plus APT and rivaroxaban alone in the overall cohort or CAD and stroke subgroups.
- The combination therapy showed a trend towards increased all-cause death in the PAD subgroup (HR 4.43 [1.05-18.71]).
- Rivaroxaban plus APT significantly increased any bleeding in the overall cohort (HR 1.28 [1.01-1.62]) and stroke subgroup (HR 1.42 [1.01-2.01]), and major bleeding in the CAD subgroup (HR 2.00 [1.01-3.93]).
Conclusions:
- Rivaroxaban combined with APT did not provide additional ischemic benefits for patients with NVAF and stable CAD or ischemic stroke.
- This combination therapy was associated with an increased risk of bleeding events in patients with NVAF and stable CAD or ischemic stroke.
Aim:
In this subanalysis of the EXPAND study, we evaluated the risks and benefits of rivaroxaban plus antiplatelet therapy (APT) for patients with non-valvular atrial fibrillation (NVAF) complicated by stable coronary artery disease (CAD), ischemic stroke, or peripheral artery disease (PAD).
Methods:
From the EXPAND study population (n=7,141), patients with NVAF complicated by stable CAD (n=886), ischemic stroke (n=1,231), or PAD (n=160) were included. Patients complicated by any of them were set as ALL (n=2,030). Patients were all treated with rivaroxaban (10 or 15 mg/day) with (+) or without (-) APT. Efficacy outcomes were symptomatic stroke＋systemic embolism (SE), symptomatic stroke＋SE＋myocardial infarction＋cardiovascular death, and all-cause death. Safety outcomes included major and any bleeding. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated for differences between the APT(+) and APT(-) groups.
Results:
There were no significant differences in the efficacy outcomes between the APT(+) and APT(-) groups in the ALL cohort or in the CAD and STROKE sub-cohorts. In the PAD subcohort, the HR [95% CI] for all-cause death in the APT(+) group increased (4.43 [1.05-18.71]; p=0.043). In the APT(+) group, the HR [95% CI] for any bleeding increased in the ALL cohort (1.28 [1.01-1.62]; p=0.044) and STROKE subcohort (1.42 [1.01-2.01]; p=0.047), and for major bleeding in the CAD subcohort (2.00 [1.01-3.93]; p=0.046).
Conclusions:
Rivaroxaban with APT did not reduce ischemic outcomes in patients with stable CAD or ischemic stroke; however, it did increase the risk of bleeding in patients with stable CAD or ischemic stroke.
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