NEW ORLEANS, LA—Use of bivalirudin after initial management with thrombolytics appears to be as safe as unfractionated heparin for primary percutaneous coronary intervention (PPCI), according to the results of a retrospective study to determine the safety and efficacy of bivalirudin in this patient population as reported at ACC.11, the American College of Cardiology’s 60th Annual Scientific Session.
The study identified 104 consecutive patients treated with primary PCI who had received full-dose thrombolytic therapy within the previous 6 hours. While thrombolytic therapy is used for patients presenting with STEMI, safety and efficacy of bivalirudin during PCI in these patients has not been established, said Gabriel Sardi, MD, and colleagues from Washington Hospital Center, Washington, DC, in explaining their rationale for the study, which compared use of intraprocedural unfractionated heparin and bivalirudin on in-hospital bleeding and ischemic events.
Data for 47 patients (45%) treated with bivalirudin and 57 patients (55%) treated with unfractionated heparin were analyzed. Baseline characteristics were similar in both groups. Patients treated with bivalirudin were 56.6 ±14.7 years of age and 83% were male; those receiving unfractionated heparin were 55.4 ±10.8 years of age and 86% were male.
Patients on bivalirudin received low-molecular weight heparin more frequently (42.6% vs 21.4%; P=0.021) and were more frequently preloaded with clopidogrel (56.5% vs 28.1%; P<0.001). Intraprocedural glycoprotein IIb/IIIa inhibitors were used only in unfractionated heparin patients.
Incidence of thrombolysis in myocardial infarction (TIMI) major bleeding was similar, they reported; 4.4% in the bivalirudin group and 8.8% in the unfractionated heparin group (P=0.84). Other bleeding events and ischemic endpoints were more frequent in patients treated with unfractionated heparin but results did not reach statistical significance. The primary composite outcome occurred more frequently in patients receiving unfractionated heparin, reaching borderline statistical significance (6.4% for bivalirudin and 21.1% for unfractionated heparin, P=0.03). A total of 2.1% of patients in the bivalirudin group died, compared with 5.3% in the unfractionated heparin group (P=0.625).
The investigators concluded that a randomized trial addressing safety and outcomes of bivalirudin after lytic therapy is warranted.