Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization
Topic: Antiplatelets in acute coronary syndrome
- Determine benefits of intensified platelet inhibition in patients with unstable angina or non ST elevation MI who do not undergo revascularization.
- Multi-centered, double blinded, randomized clinical trial
- Prasegruel (30 mg loading dose, followed by 10mg daily, adjusted to 5mg daily for patient > 75 years old or weighed less than 60kg) with aspirin (100mg or less daily) and placebo.
- Clopidogrel (300 mg loading dose, followed by 75 mg daliy) with aspirin (100 mg or less daily) and placebo.
- 7,243 patients
- Patients were required to have at least one of four risk criteria: an age of at least 60 years, the presence of diabetes mellitus, previous myocardial infarction, or previous revascularization with either PCI or coronary-artery bypass grafting (CABG).
- Patients with ACS selected for medical management without revascularization within 10 days of index event.
- 1 mm ST-depression in two or more leads and negative biomarkers.
- History of transient ischemic attack or stroke, PCI or CABG within the previous 30 days, renal failure requiring dialysis, and concomitant treatment with an oral anticoagulant.
- 17 months
- Composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients under the age of 75 years.
- Death from cardiovascular causes, all myocardial infarctions, and strokes
- Mean age 66, 39% were women.
- At a median follow-up of 17 months, the primary end point occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (HR 0.91; CI, 0.79 to 1.05; P=0.21).
- Ischemic events (all components of the primary end point) were lower in the prasugrel group among patients under the age of 75 years (hazard ratio, 0.85; CI, 0.72 to 1.00; P=0.04).
- Rates of severe and intracranial bleeding were similar in the two groups in all age groups.
- Higher frequency of heart failure in the clopidogrel group (data not shown).
TAKE AWAY: Among patients with unstable angina or myocardial infarction without ST-segment elevation not undergoing revascularization, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed.