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CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention

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CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention

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    1. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce RecurrENT events – seventh Organization to Assess Strategies in Ischemic Symptoms Purpose To assess whether doubling of the loading and maintenance dose of clopidogrel for 7 days was better than the standard dose, and whether high-dose aspirin was better than low-dose aspirin in patients undergoing percutaneous coronary intervention (PCI). Reference Mehta SR, Tanguay JF, Eikelboom JW, et al. for the CURRENT-OASIS 7 Investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet 2010;376:1233–1243.

    2. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - TRIAL DESIGN - Design Randomized trial with a 2x2 factorial design. Patients 25,086 patients with acute coronary syndromes (ACS) with or without ST-segment elevation and electrocardiographic evidence of ischemia or raised biomarkers. Exclusion criteria included an increased risk of, or active, bleeding. Follow-up, primary and secondary endpoints The primary outcome was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke by 30 days. Secondary outcomes were the primary outcome plus recurrent ischemia, individual outcome components and stent thrombosis. Treatment Clopidogrel 600 mg on day 1 and 150 mg once daily (od) on days 2–7, or 300 mg on day 1 and 75 mg od on days 2–7, plus aspirin =300 mg on day 1 and 300–325 mg or 75–100 mg daily on days 2–30. Other therapies were left to the discretion of the attending physician.

    3. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - TRIAL DESIGN continued -

    4. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - RESULTS - Primary and secondary endpoints In the clopidogrel dose comparison, the primary outcome occurred in 3.9% of patients receiving a double dose. It also occurred in 4.5% of patients receiving standard dose (adjusted hazard ratio [HR], 0.86; p=0.039). Rates of the secondary combined outcome were also significantly lower in the double-dose group, at 4.2% versus 5.0% in the standard-dose group (adjusted HR, 0.85; p=0.025). There was no significant difference in the rate of the primary outcome or the combined secondary outcome between the high- and low-dose aspirin groups, at 4.1% versus 4.2% (adjusted HR, 0.98; p=0.76) and 4.4% versus 4.8% (adjusted HR, 0.92; p=0.92), respectively. No significant differences in the rate of definite or probable stent thrombosis were observed between high- and low-dose aspirin groups (adjusted HR, 0.90; p=0.36). Differences between aspirin and clopidogrel dose comparisons There was nominally significant heterogeneity between the aspirin and clopidogrel dose groups for the primary outcome (p=0.026). There was no significant heterogeneity for major bleeding (p=0.42).

    5. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - RESULTS continued -

    6. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - RESULTS continued -

    7. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - RESULTS continued -

    8. CURRENT-OASIS 7: Clopidogrel and aspirin optimal dose Usage in individuals undergoing percutaneous coronary intervention to Reduce Recurrent evENTs – seventh Organization to Assess Strategies in Ischemic Symptoms - SUMMARY - A 7-day double dose of clopidogrel was more effective than the standard-dose regimen in the prevention of the primary outcome of CV death, MI, or stroke, and stent thrombosis for patients who underwent PCI. In contrast, high-dose aspirin did not differ significantly from low-dose aspirin in prevention of these outcomes. Double-dose clopidogrel increased the risk of major bleeding, but the risk of bleeding that was intracranial or fatal did not increase. Major bleeding did not differ between high-dose and low-dose aspirin groups. A double-dose clopidogrel regimen can be considered for all patients with ACS treated with an early invasive strategy and intended PCI.

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