Aspirin and coumadin after acute coronary syndromes (the ASPECT-2 study): a randomised controlled trial
Topic: Antiplatelets in acute coronary syndrome
- Determine whether combination of aspirin and oral anticoagulation with coumadin is superior to aspirin alone in prevention of recurrent MI after ACS.
- Prospective, multi-centered, randomized, open-label trial (intention to treat analysis)
- Coumadin alone (INR goal 3.0-4.0) or Coumadin (INR goal 2.0-2.5) with low dose aspirin (80 mg)
- Low dose aspirin (80 mg)
- 999 patients
- Patients with ACS (MI or UA) within the preceding 8 weeks.
- Contraindication to anticoagulation
- Other established indication for anticoagulation
- Planned revascularization
- Serious comorbidity
- Abnormal blood platelets or erythrocytes
- History of stroke
- 350 days
- Time to first occurrence of death, myocardial infarction, or stroke.
- Major bleeding defined as fatal bleeding, CNS bleeding, or any bleeding requireing admission. All other bleeding classified as minor.
- Death from all causes (vascular death, myocardial infarction, unstable angina, cardiac interventions, stroke) and episodes of bleeding. Vascular death included sudden death or death from stroke, myocardial infarction, congestive heart failure, peripheral vascular disease, hemorrhage, or other vascular causes.
- Mean age 60.8, 79% were men.
- Mean INR in the Coumadin alone and combination groups were 3.2 and 2.4, respectively.
- The primary endpoint was reached in 31 (9%) of 336 patients on aspirin, in 17 (5%) of 325 on anticoagulants (HR 0.55, CI 0.30–1.00, p=0.0479), and in 16 (5%) of 332 on combination therapy (HR 0.50 [0.27–0.92], p=0.03).
- Major bleeding was recorded in three (1%) patients on aspirin, three (1%) on anticoagulants (HR 1.03 [0.21–5.08], p=1.0), and seven (2%) on combination therapy (HR 2.35 [0.61–9.10], p=0.2).
- Frequency of minor bleeding was 5%, 8% (1.68 [0.92–3.07], p=0.20), and 15% (3.13 [1.82–5.37], p=<0.0001), in the three groups, respectively.
TAKE AWAY: In patients recently admitted with acute coronary events, treatment with high-intensity oral anticoagulants or aspirin with medium-intensity oral anticoagulants was more effective than aspirin on its own in reduction of subsequent cardiovascular events and death.