In patients with NVAF and PAD, rivaroxaban and apixaban had similar rates of MALE (aHR 1.20; 95% CI 0.87-1.65) and stroke/TIA/SE, but rivaroxaban was associated with higher major bleeding risk.
Cohort (n=16,160)
Sí
Does rivaroxaban compared to apixaban improve effectiveness or reduce bleeding in patients with non-valvular atrial fibrillation and peripheral artery disease?
In patients with NVAF and PAD, apixaban may be a safer anticoagulant choice than rivaroxaban due to a lower risk of major bleeding with similar effectiveness against ischemic and limb events.
Estimación del efecto: aHR 1.20 (95% CI 0.87-1.65)
Tasa de eventos absoluta: 6.7% vs 5.6%
Abstract Background/Introduction Peripheral artery disease (PAD) increases the risk of stroke, cardiovascular death, and major adverse limb events (MALE) in patients with atrial fibrillation (AF). However, the effectiveness and safety of rivaroxaban compared with apixaban in patients with both NVAF and PAD is unclear, especially for MALE, a critical outcome in PAD. Purpose To compare the effectiveness and safety of rivaroxaban versus apixaban in patients with NVAF and PAD. Methods Using the UK Clinical Practice Research Datalink, a large primary care database, we formed a cohort of patients aged ≥45 years with incident NVAF and PAD who initiated rivaroxaban or apixaban between 2013 and 2021. Cohort entry was defined as the first prescription for rivaroxaban or apixaban following NVAF diagnosis. The primary effectiveness outcomes were MALE, defined as hospitalization for acute limb ischemia or major amputation, and a composite of ischemic stroke, transient ischemic attack (TIA), or systemic embolism (SE). The primary safety outcome was major bleeding defined as bleeding requiring hospitalization or resulting in death. We used propensity score fine stratification and weighting for confounding control. We fit weighted Cox proportional hazards models to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for each outcome associated with rivaroxaban compared with apixaban. Results The cohort included 6,170 new-users of rivaroxaban and 9,990 new-users of apixaban. Rivaroxaban and apixaban had similar incidence rates of MALE (adjusted rates 6.7 vs. 5.6 per 1,000 person-years; adjusted HR (aHR) 1,20; 95% CI 0.87-1.65) and stroke/TIA/SE (adjusted rates 24.5 vs. 21.3 per 1,000 person-years; aHR 1,15; 95% CI 0.97-1.36). Major bleeding rates were higher with rivaroxaban (adjusted rates 46.1 vs. 29.8 per 1,000 person-years; aHR 1,55; 95% CI 1.36-1.77). The risk remained higher for all bleeding sites (intracranial hemorrhage: (HR 1.65; 95% CI 1.03-2.66), gastro-intestinal bleeding: (HR 1.52; 95% CI 1.17-1.98) and other bleeding: (HR 1.59; 95% CI 1.22-2.08)) Conclusion In patients with NVAF and PAD, rivaroxaban and apixaban showed similar effectiveness for preventing MALE and stroke/TIA/SE. However, rivaroxaban was associated with a higher risk of major bleeding. These findings support apixaban as a potentially safer anticoagulant in this high-risk population.
Dari et al. (Sat,) conducted a cohort in Non-valvular atrial fibrillation (NVAF) and peripheral artery disease (PAD) (n=16,160). Rivaroxaban vs. Apixaban was evaluated on Major adverse limb events (MALE) (aHR 1.20, 95% CI 0.87-1.65). In patients with NVAF and PAD, rivaroxaban and apixaban had similar rates of MALE (aHR 1.20; 95% CI 0.87-1.65) and stroke/TIA/SE, but rivaroxaban was associated with higher major bleeding risk.