WEDNESDAY, Sept. 1 (HealthDay News) -- In patients with acute coronary syndromes (ACS) referred for an invasive intervention, there is no overall difference between double-dose clopidogrel and the standard regimen, or between higher-dose and lower-dose aspirin, for reducing cardiovascular death, myocardial infarction, or stroke, according to research published in the Sept. 2 issue of the New England Journal of Medicine. However, according to research published online Sept. 1 in The Lancet, double-dose clopidogrel is associated with reduced cardiovascular events and stent thrombosis in patients undergoing percutaneous coronary intervention (PCI) for ACS. This research has been published to coincide with the European Society of Cardiology Congress, held from Aug. 28 to Sept. 1 in Stockholm, Sweden.
For the NEJM study, Shamir R. Mehta, M.D., of McMaster University in Hamilton, Canada, and other CURRENT-OASIS 7 investigators randomized 25,086 patients with ACS awaiting an invasive procedure to treatment with double-dose clopidogrel or standard-dose clopidogrel and either higher-dose aspirin or lower-dose aspirin. The primary outcome (cardiovascular death, myocardial infarction, or stroke) occurred in 4.2 percent of patients receiving double-dose clopidogrel versus 4.4 percent taking the standard dose (P = 0.30), while major bleeding occurred in 2.5 versus 2.0 percent (P = 0.01). There were no significant differences in the primary outcome or major bleeding rates between the two aspirin groups.
However, in The Lancet study, Mehta and colleagues analyzed the CURRENT-OASIS 7 subgroup undergoing PCI and found that double-dose clopidogrel significantly reduced the rate of the primary outcome compared to the standard dose (3.9 versus 4.5 percent) and definite stent thrombosis (0.7 versus 1.3 percent). Major bleeding was more common with double-dose than with standard-dose clopidogrel (1.6 versus 1.1 percent). For the primary outcome and major bleeding, there were no differences between the two aspirin groups.
"A double-dose clopidogrel regimen can be considered for all patients with ACS treated with an early invasive strategy and intended early PCI," the authors of the second study write.
The research was funded by Sanofi-Aventis and Bristol-Myers Squibb, and study authors disclosed financial ties to these and other pharmaceutical and/or medical device companies.
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