Blood pressure and antithrombotic in atrial fibrillation and coronary disease

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation and stable coronary artery disease (n=2135). Intervention: Low systolic blood pressure (≤126 mmHg) vs. High systolic blood pressure (>126 mmHg). Primary outcome: Composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and all-cause death (HR 1.38, 95% CI 1.01-1.88, p=0.039).

Shinichi Yamanaka; Takashi Noda; Kotaro Nochioka; Takumi Higuma; Koichi Kaikita; Masaharu Akao; Junya Ako; Tetsuya Matoba; Masato Nakamura; Katsumi Miyauchi; Nobuhisa Hagiwara; Kazuo Kimura; Kunihiko Matsui; Hisao Ogawa; Satoshi Yasuda

doi:10.1101/2025.05.20.25328043

May 21, 2025Open Access

Blood pressure and antithrombotic in atrial fibrillation and coronary disease

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Key result

Lower systolic blood pressure (≤126 mmHg) increased the risk of cardiovascular events and all-cause death by 38% (HR 1.38) compared to higher blood pressure in patients with AF and stable CAD.

Why the study?

The prognostic relevance of lower systolic blood pressure and the optimal antithrombotic strategy in patients with AF and stable CAD remained to be clarified.

Does rivaroxaban monotherapy improve cardiovascular outcomes and major bleeding compared to combination therapy in patients with atrial fibrillation and stable coronary artery disease stratified by systolic blood pressure?

Key Points

This analysis aims to clarify the impact of systolic blood pressure and antithrombotic strategies in patients with atrial fibrillation and coronary artery disease.
Conducted post-hoc analysis of the AFIRE trial with a median blood pressure stratification.
Stratified participants into high (>126 mmHg) and low (≤126 mmHg) systolic blood pressure groups.
Primary endpoints included cardiovascular events and all-cause death, as well as major bleeding.
The Low SBP group had a significantly higher incidence of primary efficacy endpoint (HR 1.38, 95% CI 1.01–1.88, p=0.039).
Rivaroxaban monotherapy in the Low SBP group was associated with lower risks for both efficacy (HR 0.66, 95% CI 0.41–0.86, p=0.006) and safety endpoints (HR 0.40, 95% CI 0.22–0.74, p=0.003).
No significant differences were observed in the High SBP group regarding treatment outcomes.

Study Design

Type

Cohort (n=2,135)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does rivaroxaban monotherapy improve cardiovascular outcomes and major bleeding compared to combination therapy in patients with atrial fibrillation and stable coronary artery disease stratified by systolic blood pressure?

P

Population

2,135 patients aged 20 years or older with atrial fibrillation and stable coronary artery disease, stratified by baseline systolic blood pressure.

E

Exposure

Rivaroxaban monotherapy (10 mg once daily for creatinine clearance 15–49 mL/min, or 15 mg once daily for creatinine clearance ≥50 mL/min)

C

Comparator

Combination therapy with rivaroxaban plus a single antiplatelet agent (aspirin or a P2Y12 inhibitor)

O

Outcome

Composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and all-cause deathcomposite

Main Result

Hazard Ratio: 1.38 (95% CI 1.01–1.88)

p-value: p=0.039

Limitations

Post-hoc analysis of a randomized trial
Exclusion of patients with uncontrolled hypertension (SBP ≥160 mmHg) limits the ability to assess risks associated with markedly elevated SBP
Dividing the cohort into subgroups reduced the number of patients available for each analysis, limiting statistical power
SBP was assessed only at baseline, leaving longitudinal effects uncertain
Patients with uncontrolled hypertension (SBP ≥160 mmHg) were excluded
The Low SBP group may have included a heterogeneous population

Implication

In patients with atrial fibrillation and stable coronary artery disease, lower systolic blood pressure is associated with increased cardiovascular risk, and rivaroxaban monotherapy provides superior efficacy and safety compared to combination therapy specifically in this lower SBP subgroup.

Abstract

Backgrounds Atrial fibrillation (AF) is a risk factor for adverse cardiovascular outcomes in patients with stable coronary artery disease (CAD). The prognostic relevance of lower systolic blood pressure (SBP) and the optimal antithrombotic strategy in patients with AF and CAD remain to be clarified. Methods This post-hoc analysis of the AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease) trial stratified participants 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, 0.66; 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 compared with combination therapy, particularly among patients with lower SBP.

Discussion

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Cite This Study

Yamanaka et al. (2025) conducted a cohort in Atrial fibrillation and stable coronary artery disease (n=2,135). Low systolic blood pressure (≤126 mmHg) vs. High systolic blood pressure (>126 mmHg) was evaluated on Composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and all-cause death (HR 1.38, 95% CI 1.01-1.88, p=0.039). Lower systolic blood pressure (≤126 mmHg) increased the risk of cardiovascular events and all-cause death by 38% (HR 1.38) compared to higher blood pressure in patients with AF and stable CAD.

synapsesocial.com/papers/6a2174d9db71e1dfcf8b6c4b https://doi.org/10.1101/2025.05.20.25328043