Introduction
Epidemiology
Myocardial Infarction
Left Ventricular Thrombus
Wall Motion Abnormalities and Reduced Left Ventricular Ejection Fraction
Associated Mechanisms and Risk of Stroke
Ischemic Stroke Prevention
Prevention of Ischemic Stroke in Patients with Acute MI
Stroke Prevention in Patients with LVT
Prevention of Ischemic Stroke in Patients with Reduced LVEF or WMA
Name of clinical trial | Inclusion criteria | Treatment | Primary outcome | Number of patients | Mean follow-up | Result primary outcome | Stroke | Major hemorraghe |
---|---|---|---|---|---|---|---|---|
WARCEF | LVEF < 35% | Warfarin (INR 2.0–3.5) versus aspirin | Time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause | 2860 | 6 years | 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% CI 0.79 to 1.10; P = 0.40) | 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). |
COMMANDER HF | LVEF ≤ 40% and coronary heart disease, NT-proBNP ≥ 800 pp per ml or BNP ≥ 200 pp per ml | Rivaroxaban at a dose of 2.5 mg twice daily versus placebo | Composite of death from any cause, myocardial infarction, or stroke | 5022 | 21.1 months | Primary end point occurred in 626 (25.0%) of 2507 patients assigned to rivaroxaban and in 658 (26.2%) of 2515 patients assigned to placebo (hazard ratio, 0.94; 95% confidence interval [CI], 0.84 to 1.05; P = 0.27) | The rates of stroke were 2.0% and 3.0%, in the rivaroxaban and warfarin groups respectively (hazard ratio, 0.66; 95% CI, 0.47 to 0.95) | 18 patients (0.7%) assigned to rivaroxaban and 23 (0.9%) assigned to placebo (hazard ratio, 0.80; 95% CI, 0.43 to 1.49; P = 0.48). |
HELAS | Symptomatic HF, in NYHA class II-IV and an ejection fraction < 35% | Warfarin versus placebo and aspirin versus warfarin | Composite endpoint of nonfatal stroke, peripheral or pulmonary embolism, myocardial (re)infarction, re-hospitalization, exacerbation of heart failure, or death from any cause | 197 | 312 patient years of follow-up | The study results showed no significant difference in the incidence of thromboembolism between groups | Only five strokes were recorded. Due to the small number of patients enrolled, it was not possible to evaluate differences in efficacy between the treatment groups | Major hemorrhage only occurred in the warfarin groups, at a rate of 4.6 per 100 patient years. |
WASH | Clinical diagnosis of heart failure requiring treatment with diuretics, evidence of left ventricular systolic dysfunction on echocardiography, Echocardiographic criteria of left ventricular dysfunction included an increased left ventricular end-diastolic internal dimension (≥ 56 mm or ≥ 30 mm/m2 body surface area) combined with a fractional shortening of ≤ 28% or an echocardiographic ejection fraction ≤ 35% | Warfarin versus aspirin | Composite outcome of death, nonfatal myocardial infarction, and nonfatal stroke | 279 | 27 ± 1 months | No significant difference between the groups in the composite end point of death, stroke, or MI | No significant difference between the groups in stroke | Five major hemorrhagic events occurred. One on aspirin, 2 on warfarin, 1 in a patient who had been withdrawn from warfarin because of a minor bleeding episode 2 years before the event, and 1 who had been withdrawn from warfarin 2 weeks before the event because of the development of a contraindication. |
WATCH | Symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of ≤ = 35% | Warfarin, aspirin, or clopidogrel | Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke | 1587 | 1.9 years (median, 21 months) | Terminated early as a result of failure to reach target enrollment No significant difference among groups in the composite end point of death, nonfatal MI, or nonfatal stroke was observed in those who had been enrolled | Warfarin was associated with fewer nonfatal strokes than aspirin or clopidogrel | Major bleeding episodes were more frequent in warfarin patients compared with clopidogrel (P < 0.01) but not aspirin (P = 0.22) patients. |