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Post-hoc analysis links lower systolic BP to higher cardiovascular risk in AF and stable CADLower blood pressure linked to higher risk in AF patients with heart disease

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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.

Researchers analyzed data from a previous clinical trial involving over 2,100 patients who had both atrial fibrillation (an irregular heartbeat) and stable coronary artery disease (narrowed heart arteries). They split patients into two groups based on their baseline systolic blood pressure (the top number in a blood pressure reading): a 'high' group (over 126 mmHg) and a 'low' group (126 mmHg or less). The main goal was to see if blood pressure levels and different blood-thinning treatments affected patient outcomes.

They found that patients in the low blood pressure group had a 38% higher risk of experiencing a cardiovascular event (like a heart attack or stroke) or dying from any cause, compared to the high blood pressure group. Within the low blood pressure group, patients who took just the blood thinner rivaroxaban had a lower risk of these events and a lower risk of major bleeding compared to those who took rivaroxaban plus an antiplatelet drug (like aspirin).

It is very important to understand that this was a 'post-hoc' analysis. This means researchers looked back at data that was already collected for a different purpose. The findings show an association or link, but they do not prove that lower blood pressure caused the worse outcomes. The results are specific to the patients in this particular trial and may not apply to everyone.

Readers should take from this that managing blood pressure and blood-thinning therapy in patients with these two heart conditions is complex. This analysis provides an interesting observation for doctors to consider, but it is not strong enough evidence to change current medical practice. Patients should not make any changes to their medications or blood pressure goals based on this study alone and should always talk with their own doctor.

What this means for you:
Lower blood pressure was linked to higher risk in a specific heart patient group, but this finding needs more research.

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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