![]() Indirect comparisons of rates of bleeding outcomes across trials provide particular challenges because of variability in the definitions and reporting of major bleeding, but are important because bleeding is at least as frequent as ischaemic events and is associated with a substantial risk of morbidity and mortality. Although indirect comparisons across trials are subject to confounding because of differences in patients characteristics, cointerventions, and outcome definitions, they are important for clinicians faced with having to choose the best treatment for their patients. Randomized controlled trials provide the most valid comparisons of the efficacy and safety of two treatments but the new oral P2Y 12 inhibitors have not been directly compared with double-dose clopidogrel or with one another. 4–6 The new oral P2Y 12 inhibitors and double-dose clopidogrel were associated with improved efficacy compared with standard doses of clopidogrel, but in some trials these new treatment strategies also increased major bleeding. 1, 2 Concern about clopidogrel's delayed onset and offset of action, incomplete inhibition of the platelet P2Y 12 receptor and variability in patient response to the drug 3 has prompted evaluation, in large randomized controlled trials, of the efficacy and safety of new more potent and rapidly acting oral P2Y 12 inhibitors and of double-dose clopidogrel (600 mg loading dose, 150 mg daily for 6-days, 75 mg daily thereafter) compared with standard-dose clopidogrel (300 mg loading dose, 75 mg daily thereafter). The combination of aspirin and clopidogrel has been the standard of antiplatelet therapy across the spectrum of patients with acute coronary syndromes (ACS) and in those undergoing percutaneous coronary intervention (PCI). The contrast in bleeding rates of standard-dose clopidogrel among the trials was attenuated when using the thrombolysis in myocardial infarction (TIMI) definition for major bleeding (range 1.1–7.7%) and bleeding rates in all the trials were less than 2% when comparing 30 day rates of non-coronary artery bypass graft surgery-related TIMI major bleeding (range 0.3–1.9%).īleeding, P2Y 12 inhibitors, Acute coronary syndrome, Definition Introduction Using the trial definition, major bleeding rates in patients treated with standard-dose clopidogrel ranged from 0.6% in COMMIT to 11.2% in PLATO. clopidogrel double-dose (600-mg loading dose, 150-mg daily for 6-days, 75-mg daily thereafter) (CURRENT-OASIS 7). prasugrel (TRITON-TIMI 38) or ticagrelor (PLATO) and clopidogrel standard-dose vs. placebo (CURE, CLARITY-TIMI 28, COMMIT), clopidogrel standard-dose vs. The trials compared clopidogrel standard-dose (300-mg loading dose, 75-mg daily thereafter) vs. Electronic searches identified six phase III randomized controlled oral P2Y 12 inhibitor trials published between 20 involving 119 020 patients with ACS. ![]()
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