Effectiveness of the concomitant use of bivalirudin and drug-eluting stents (from the prospective, multicenter BivAlirudin and Drug-Eluting STents [ADEST] study).

Sirolimus-eluting stents (SESs) reduce restenosis compared with bare metal stents. Safety issues with drug-eluting stents are particularly important given concerns of possible increased thrombogenicity. Compared with heparin plus glycoprotein IIb/IIIa inhibitors, the direct thrombin inhibitor bivalirudin has been shown to reduce the risk of hemorrhagic complications in patients receiving bare metal stents, with similar efficacy in preventing ischemic complications. The safety and efficacy of percutaneous coronary intervention (PCI) with SESs and bivalirudin anticoagulation have not been prospectively studied. This prospective study performed at 9 United States hospitals evaluated 1,182 patients referred for PCI with SESs in whom the procedural anticoagulant was bivalirudin. Clopidogrel was administered before PCI in 79% of patients, and only 5.3% received procedural glycoprotein IIb/IIIa inhibitors. At 30 days, major adverse cardiac events occurred in 7.1% of patients, including 0.3% mortality, 4.4% myocardial infarction (defined as creatine kinase-MB >3x normal), 1.7% target vessel revascularization, and 0.6% stent thrombosis. Major bleeding occurred in only 0.8% of patients. Thus, use of bivalirudin as the procedural anticoagulant to support SES implantation in a "real world" population of patients undergoing PCI results in low rates of major adverse cardiac events, stent thrombosis, and major bleeding.

Anticoagulation with bivalirudin during percutaneous coronary intervention for ST-segment elevation myocardial infarction.

OBJECTIVE: The objective of this retrospective analysis of high-risk patients treated with bivalirudin during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) was to evaluate the safety and feasibility of direct thrombin inhibitor (DTI) without concomitant glycoprotein (GP) IIb/IIIa inhibition. BACKGROUND: Reperfusion by PCI is the treatment of choice for patients with STEMI. In patients with stable or unstable angina without ST-segment elevation undergoing PCI, bivalirudin was at least as effective as heparin plus GPIIb/IIIa inhibitors in reducing ischemic events and more effective in preventing bleeding. There are no published studies detailing the use of bivalirudin in patients with STEMI. METHODS: From 09/02 to 05/03 at the Heart Care Centers of Illinois, Blue Island, Illinois. Ninety-one consecutive patients with STEMI underwent PCI with or without stent placement. Bivalirudin was administered as a bolus dose (0.75 mg/kg) followed by infusion (1.75 mg/kg/hr) for the duration of the procedure. Outcomes were recorded over a 30-day follow-up period. RESULTS: Patients (n = 91) had several high-risk characteristics (40% female, 30% diabetes mellitus, 21% previous MI and 18% cardiogenic shock). PCI procedures utilized balloons, stents, or a combination of both. Intraaortic balloon pumps were used for 41% and closure devices for 24% of patients. CONCLUSIONS: This evaluation demonstrates excellent TIMI flow without the addition of GPIIb/IIIa inhibitors. The low mortality and complication rates suggest anticoagulation with bivalirudin in patients with STEMI undergoing PCI is feasible and warrants further study in larger controlled trials to evaluate the effectiveness of bivalirudin in this patient population.