Background: Bivalirudin (Angiomax^짰) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions (PCI). This study aimed to evaluate the efficacy and safety of bivalirudin as compared to heparin, as an antithrombotic regimen in patients treated with Sirolimus-eluting Stents (SES, Cypher^TM).
Methods: A total 675 pts with 750 lesions underwent standard PCI with SES for various coronary artery lesions. Patients were treated with either bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg/hr infusion, n=323) or heparin alone (40 U/kg bolus, n=352) during PCI. The procedural, in-hospital and 30-day clinical outcomes in both groups were compared.
Results: Baseline clinical and angiographic parameters were similar between both groups. Although major bleeding complications were similar between both groups, the patients in the bivalirudin group had lower overall vascular complications (0.01% vs. 3.7%, P=0.01), periprocedural ischemic events (non-Q-wave MI with major CK-MB elevation), and demonstrated a trend toward less transfusion (2.6% vs. 6.4%, P=0.06). At 30 days, non-Q-wave MI continued to be lower in the bivalirudin group (9.1% vs.15.3%, P=0.05) although death, Q-wave MI, TLR, TVR and MACE were similar between both groups.
Conclusion: Bivalirudin, as a single antithrombotic agent in patients undergoing PCI with SES, is clinically safe and feasible with lower vascular and ischemic complications as compared with heparin. In-hospital outcome and 30-day clinical follow-up results showed that the use of bivalirudin was related to less periprocedural and early ischemic events compared to heparin.