Objective: This open label, prospective, non-comparative trial is the first to evaluate the safety and feasibility of bivalirudin (Angiomax(R), the Medicines Company, Parsippany, NJ), during PCI with implantation of the sirolimus eluting stent (Cypher, Cordis a J & J, Warren, NJ) or the paclitaxel eluting stent (Taxus, Boston Scientific, Natick, MA).
Methods: Patients who were referred for elective PCI suitable for stent implantation were recruited. Bivalirudin was administrated as a bolus of 1.0 mg/kg followed by 2.5 mg/kg/hour infusion for up to 4 hours in the first 68 patients. Following REPLACE 2 study, patients were treated with a lower dose of bivalirudin (0.75 mg/kg followed by 1.75 mg/kg/hour infusion).
Results: 111 patients with 139 lesions were included in the study. Thirty-one (27.9%) were diabetics, 14 (12.6%) had unstable angina and 79 (66.6%) had multivessel disease. Complex lesion morphology was present in 65 (46.7%), in-stent restenosis in 32 (23%), total occlusion 7 (5%) and bifurcations 22 (15.8%). Activated clotting time (ACT) was verified to be therapeutic following bivalirudin administration. During the index procedure no patients required provisional use of glycoprotein (GP) IIb/IIIa inhibitors. One patient had intracoronary thrombosis which resolved after stenting. An additional 2 patients had non-Q wave myocardial infarction (MI). No patients died, had major bleeding, required transfusions or sustained vascular complications. 1 patient developed thrombosis at 4 months with a documented MI. At 6 month follow-up, 3 (2.7%) patients died and 12 (10.8%) patients had target lesion revascularization (1 CABG and 11 re-PCI). Angiographic follow-up was achieved in 98 patients (89.9%).
Conclusions: This study indicates the safety and feasibility of Cypher or Taxus stent implantation in conjunction with bivalirudin administration, with no elective use of GP IIb/IIIa inhibitors.