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Published on: February 26, 2013
Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease:
Koichi Kaikita1,2, Satoshi Yasuda3,4, Masaharu Akao5
1Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Kiyotake, Japan (K. Kaikita).
Insights
Major bleeding significantly increases the risk of major adverse cardiac and cerebrovascular events (MACCE) in patients with atrial fibrillation and stable coronary artery disease. Preventing bleeding is crucial for reducing cardiovascular events and mortality.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Early bleeding post-percutaneous coronary intervention (PCI) is linked to mortality and myocardial infarction.
- The relationship between bleeding and major adverse cardiac and cerebrovascular events (MACCE) in atrial fibrillation (AF) patients with stable coronary artery disease (CAD) requires clarification.
Purpose of the Study:
- To investigate the association between bleeding events and subsequent MACCE in patients with AF and stable CAD.
Main Methods:
- A post hoc analysis of the AFIRE trial involving 2215 patients with AF and stable CAD treated with rivaroxaban or rivaroxaban plus antiplatelet.
- MACCE defined as composite of stroke, systemic embolism, myocardial infarction, unstable angina, or death.
- Time-adjusted Cox multivariate analysis was used to assess the association of bleeding with MACCE, classifying bleeding per ISTH criteria.
Main Results:
- 17.4% of patients experienced bleeding; MACCE incidence was higher in patients with bleeding (8.38% vs. 4.20% per patient-year).
- Major bleeding was strongly associated with a 2.01-fold increased risk of MACCE (HR 2.01; 95% CI, 1.49-2.70).
- A temporal association was observed, with a significantly elevated MACCE risk within 30 days post-major bleeding (HR 7.81; 95% CI, 4.20-14.54).
Conclusions:
- Major bleeding is a strong predictor of subsequent MACCE in AF patients with stable CAD.
- Preventing major bleeding is essential for mitigating cardiovascular events and mortality in this patient population.
Background:
Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent major adverse cardiac and cerebrovascular events (MACCE) remains unclear in patients with atrial fibrillation and stable coronary artery disease. We thus aimed to investigate this association.
Methods:
The AFIRE trial (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) was a multicenter, open-label trial conducted in Japan. This post hoc analysis included 2215 patients with atrial fibrillation and stable coronary artery disease treated with rivaroxaban or rivaroxaban plus an antiplatelet agent. MACCE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The association of bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Bleeding events were classified according to the International Society on Thrombosis and Haemostasis criteria.
Results:
Among the 2215 patients, 386 (17.4%) had bleeding during follow-up, of whom 63 (16.3%) also experienced MACCE; MACCE incidence was higher in patients with bleeding than in those without (8.38% versus 4.20% per patient-year; hazard ratio, 2.01 [95% CI, 1.49-2.70]; P<0.001). The proportion of patients with both bleeding and MACCE (developed after bleeding) was 73.0% (46 of 63); 27.0% (17 of 63) experienced MACCE before bleeding. Time-adjusted Cox multivariate analysis revealed a temporal association between major bleeding and subsequent MACCE, with particularly high MACCE risks within 30 days after major bleeding (hazard ratio, 7.81 [95% CI, 4.20-14.54]).
Conclusions:
In patients with atrial fibrillation and stable coronary artery disease, major bleeding was strongly associated with subsequent MACCE. Thus, it is important to prevent major bleeding to avoid cardiovascular events and death. Registration: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419. Graphic Abstract: A graphic abstract is available for this article.
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