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Post-hoc analysis links lower systolic BP to higher cardiovascular risk in AF and stable CAD

Post-hoc analysis links lower systolic BP to higher cardiovascular risk in AF and stable CAD
Photo by Joachim Schnürle / Unsplash
Key Takeaway
Note association between lower SBP and higher CV risk in AF/stable CAD; monotherapy may be favorable in low SBP subgroup.

This post-hoc analysis of the AFIRE randomized controlled trial examined 2135 patients with atrial fibrillation and stable coronary artery disease, stratified by median baseline systolic blood pressure (SBP >126 mmHg vs. ≤126 mmHg). The primary comparison was between these SBP groups for a composite efficacy endpoint of cardiovascular events and all-cause death. A propensity score-matched cohort of 1684 patients was also analyzed to compare antithrombotic strategies within the lower SBP group.

Patients with baseline SBP ≤126 mmHg (Low SBP group) had a 38% higher risk of the composite efficacy endpoint compared to those with SBP >126 mmHg (High SBP group), with a hazard ratio of 1.38 (95% CI 1.01-1.88; p=0.039). Within the Low SBP group, rivaroxaban monotherapy was associated with significantly lower risks compared to rivaroxaban plus single antiplatelet therapy: a 40% lower risk for the efficacy endpoint (HR 0.60, 95% CI 0.41-0.86; p=0.006) and a 60% lower risk for major bleeding (HR 0.40, 95% CI 0.22-0.74; p=0.003). Absolute event numbers were not reported.

Safety and tolerability data beyond major bleeding were not reported. Key limitations include the post-hoc, observational nature of the analysis within the trial context, which precludes establishing causality between SBP levels and outcomes. The findings are specific to the AFIRE trial population and antithrombotic regimens studied. For practice, these results suggest an association between lower baseline systolic blood pressure and poorer cardiovascular outcomes in this dual-diagnosis population, and within that subgroup, monotherapy may offer a better risk-benefit profile than combination therapy, but this requires confirmation in prospective studies.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BACKGROUNDS: The AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease) trial demonstrated that rivaroxaban monotherapy was non-inferior in efficacy and superior in safety compared to rivaroxaban plus single antiplatelet therapy in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD). This study examined whether systolic blood pressure (SBP) affects clinical outcomes and modifies the impact of antithrombotic therapy. METHODS: In this post hoc analysis, participants were stratified based on median SBP at baseline: >126 mmHg (High SBP group, n = 1042) and ≤126 mmHg (Low SBP group, n = 1093). The primary efficacy endpoint was a composite of cardiovascular events and all-cause death. The primary safety endpoint was major bleeding. RESULTS: The mean SBP was 139 mmHg and 114 mmHg in the High and Low SBP groups, respectively. In the propensity score-matched cohort (n = 1684), the Low SBP group had a significantly higher incidence of the primary efficacy endpoint (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.01-1.88; p = 0.039), while the primary safety endpoint was comparable between groups. In the Low SBP group, rivaroxaban monotherapy was associated with lower risks of both the primary efficacy (HR, 0.60; 95% CI, 0.41-0.86; p = 0.006) and safety endpoints (HR, 0.40; 95% CI, 0.22-0.74; p = 0.003) compared with combination therapy, whereas no significant differences were observed in the High SBP group. CONCLUSIONS: Lower SBP was associated with increased risk of cardiovascular events and all-cause death. Rivaroxaban monotherapy demonstrated more favorable efficacy and safety outcomes particularly patients with lower SBP.
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