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Warfarin and aspirin in patients with heart failure and sinus rhythm
Shunichi Homma1, John L P Thompson, Patrick M Pullicino
1Columbia University Medical Center, New York, NY 10032, USA.
Insights
For heart failure patients in sinus rhythm, warfarin and aspirin showed no significant difference in preventing stroke, hemorrhage, or death. Warfarin reduced ischemic stroke risk but increased major hemorrhage risk, necessitating individualized treatment choices.
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Heart failure patients in sinus rhythm require optimal antithrombotic therapy.
- The comparative efficacy of warfarin and aspirin in this population remains unclear.
Purpose of the Study:
- To compare the effectiveness and safety of warfarin versus aspirin in patients with heart failure and reduced left ventricular ejection fraction (LVEF) in sinus rhythm.
Main Methods:
- A randomized trial involving 2305 patients with reduced LVEF in sinus rhythm.
- Patients received either warfarin (target INR 2.0-3.5) or aspirin (325 mg/day) for up to 6 years.
- The primary outcome was a composite of ischemic stroke, intracerebral hemorrhage, or all-cause death.
Main Results:
- No significant difference in the primary outcome between warfarin and aspirin groups (7.47 vs. 7.93 events per 100 patient-years).
- Warfarin significantly reduced ischemic stroke risk (0.72 vs. 1.36 events per 100 patient-years) but increased major hemorrhage risk (1.78 vs. 0.87 events per 100 patient-years).
- Intracerebral and intracranial hemorrhage rates did not differ significantly between groups.
Conclusions:
- Warfarin and aspirin offer similar overall outcomes for heart failure patients with reduced LVEF in sinus rhythm.
- The benefit of reduced ischemic stroke risk with warfarin is counterbalanced by an increased risk of major hemorrhage.
- Treatment decisions should be individualized based on patient-specific risk factors.
Background:
It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm.
Methods:
We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause.
Results:
The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P=0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P=0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P=0.82).
Conclusions:
Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized. (Funded by the National Institute of Neurological Disorders and Stroke; WARCEF ClinicalTrials.gov number, NCT00041938.).
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