Philipp Lange1, Martin Greif2, Dario Bongiovanni3, Antonia Thaumann2, Michael Näbauer2, Bernhard Bischoff4, Susanne Helbig2, Christoph Becker4, Christoph Schmitz5, Melvin D'Anastasi4, Julinda Mehilli6, Peter Boekstegers7, Steffen Massberg6, Christian Kupatt3. 1. Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany. Electronic address: philipp.lange@med.uni-muenchen.de. 2. Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany. 3. Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany; I. Medizinische Klinik und Poliklinik, Klinikum Rechts der Isar, TU, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 4. Institut für Klinische Radiologie, Klinikum Großhadern, University Hospital of Munich, Munich, Germany. 5. Herzchirurgische Klinik, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany. 6. Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 7. Medizinische Klinik für Kardiologie und Angiologie, Helios Klinikum Siegburg, Siegburg, Germany.
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 = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 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 = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 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 = 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 = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.
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 = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 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 = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 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 = 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 = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.