In AF patients with stable CAD and low SBP (≤126 mmHg), rivaroxaban monotherapy reduced primary efficacy events by 34% (HR 0.66) and major bleeding by 60% (HR 0.40) vs combination therapy.
Does rivaroxaban monotherapy improve efficacy and safety outcomes compared to combination therapy in patients with stable CAD and AF across different systolic blood pressure subgroups?
In patients with AF and stable CAD, rivaroxaban monotherapy provides superior efficacy and safety compared to combination therapy specifically in those with lower systolic blood pressure (≤126 mmHg).
Absolute Event Rate: 0% vs 0%
Abstract Background Patients with stable coronary artery disease (CAD) and atrial fibrillation (AF) are at elevated risk of adverse clinical outcomes, including stroke, myocardial infarction, and all-cause mortality. Blood pressure management plays a crucial role in this population; however, the impact of systolic blood pressure (SBP) on prognosis, particularly in patients with both AF and stable CAD, remains unclear. Previous studies have demonstrated an association between low SBP and a higher burden of comorbidities, which may influence clinical outcomes. The AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease; N Engl J Med 2019;381:1103–1113) trial established the efficacy and safety of rivaroxaban monotherapy compared to combination therapy (rivaroxaban plus a single antiplatelet) in patients with AF and stable CAD. However, whether SBP and comorbidity burden affect the choice of antithrombotic therapy in this population remains to be clarified. Purpose This post-hoc analysis of the AFIRE trial investigated the impact of SBP on clinical outcomes in patients with both AF and CAD and assessed the efficacy and safety of rivaroxaban monotherapy in different SBP subgroups. Methods A total of 2,135 patients were categorized by median baseline SBP: High SBP (126 mmHg, n=1,042) and Low SBP (≤126 mmHg, n=1,093). The primary efficacy endpoint was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or all-cause mortality; the primary safety endpoint was major bleeding. Outcomes were compared between treatment strategies within each SBP group. Results Low SBP group (mean SBP: 116 mmHg) had a higher prevalence of renal failure, myocardial infarction, and heart failure than High SBP group (mean SBP: 136 mmHg). During a median follow-up of 24.1 months, the primary efficacy events occurred more frequently in Low SBP group (hazard ratio HR 1.50, 95% confidence interval CI 1.13–1.98, p=0.004, Figure 1A). The incidence of major bleeding was comparable between groups (HR 1.30, 95% CI 0.89–2.07, p=0.14, Figure 1B). In Low SBP group, rivaroxaban monotherapy was associated with better efficacy (HR 0.66, 95% CI 0.41–0.86, p=0.006) and safety outcomes (HR 0.40, 95% CI 0.22–0.74, p=0.003, Figure 2A, B) compared with combination therapy. In contrast, in the High SBP group, efficacy and safety outcomes were similar between the two treatment strategies (efficacy: HR 0.91, 95% CI 0.58–1.40, p=0.67; safety: HR 0.99, 95% CI 0.52–1.89, p=0.99). Conclusion Patients with lower SBP and a high burden of comorbidities exhibited an increased risk of adverse clinical events. In this group, rivaroxaban monotherapy was associated with more favorable efficacy and safety outcomes compared to combination therapy. These findings highlight the potential influence of SBP and comorbidities in guiding antithrombotic strategies for patients with AF and stable CAD.
Yamanaka et al. (Sat,) reported a other. In AF patients with stable CAD and low SBP (≤126 mmHg), rivaroxaban monotherapy reduced primary efficacy events by 34% (HR 0.66) and major bleeding by 60% (HR 0.40) vs combination therapy.