Bivalirudin vs heparin in patients who undergo transcatheter aortic valve implantation

Abstract

Background: We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI). Methods: In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days. Results: No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P ¼ 0.59), major bleeding (8.3% vs 8.2%, respectively; P ¼ 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P ¼ 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P ¼ 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P ¼ 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P ¼ 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P ¼ 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P ¼ 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P ¼ 0.65). Conclusions: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.