Randomised controlled trials (RCTs) that compared use of bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitors to unfractionated heparin or enoxaparin plus glycoprotein IIb/IIIa inhibitors in patients who underwent PCI were eligible for inclusion. Follow-up needed to be at least 48 hours. The primary outcome was major adverse cardiovascular events defined as a composite of death, myocardial infarction and repeat revascularisation. Secondary endpoints were individual incidences of death, myocardial infarction, repeat revascularisation and major bleeding.
Patients in the selected trials had non-ST elevation acute coronary syndrome, unstable angina, ST-elevated myocardial infarction or underwent elective PCI. Sixty-six to 77% of the trial participants were men, 26% to 45% had a history of prior PCI and 11% to 40% of the patients had a history of prior coronary artery bypass graft (CABG) surgery. One trial excluded patients with acute myocardial infarction. Follow-up ranged from 48 hours to 30 days. Doses of bivalirudin were bolus doses of 0.5 to 0.75mg/kg with infusions of 1.75mg/kg/hour. Heparin doses ranged from 50-70 U/kg bolus. Enoxaparin doses were given in some trials at a dose of 0.5 or 1mg/kg. Administration rates of provisional glycoprotein IIb/IIIa inhibitors ranged from 7.2% to 24%. Study protocols recommended a loading dose of clopidogrel before the PCI procedure except in one trial where administration was left to the discretion of the investigators.
The authors did not state how many reviewers performed the study selection.