Benefits and risks of clopidogrel pretreatment before coronary artery bypass grafting in patients with ST-elevation myocardial infarction treated with fibrinolytics in CLARITY-TIMI 28.

The Clopidogrel as Adjunctive Reperfusion Therapy-Thrombolysis in Myocardial Infarction 28 (CLARITY-TIMI 28) trial was a randomized, double-blind, placebo-controlled study of clopidogrel in 3,491 patients receiving fibrinolytic therapy for ST-segment elevation myocardial infarction. Patients were randomized to clopidogrel or placebo begun at the time of fibrinolysis. This analysis reports the outcomes among the 136 patients in the trial population who underwent coronary artery bypass grafting (CABG) during the index hospitalization. There was no difference in the rates of TIMI major or minor bleeding between the clopidogrel and placebo groups from randomization to the end of follow-up (13.6% vs. 14.3%, P = 1.0) or from the time of CABG to the end of follow-up (9.1% vs. 11.4%, P = 0.78). When any day for study medication discontinuation < or = 5 days prior to CABG was chosen as a cut point to evaluate bleeding risk for clopidogrel vs. placebo, there was no excess bleeding in the clopidogrel group. Among patients undergoing CABG, there was a trend toward reduction in the risk of cardiovascular death, recurrent MI, or recurrent ischemia requiring urgent revascularization at 30 days for those taking clopidogrel (OR 0.66, 95% CI 0.27-1.5; P = 0.37), consistent with the benefit seen in the overall trial population (OR 0.80, CI 0.65-0.97; P = 0.03). In conclusion, early clopidogrel treatment among CLARITY-TIMI 28 patients undergoing CABG was not associated with an increase in the rate of peri-operative bleeding and showed a trend toward reduction in 30-day ischemic events.

RCT Entities:   Population Interventions Outcomes