title: 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 = 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.
authors.affiliation: Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany. Electronic address: philipp.lange@med.uni-muenchen.de.
authors.forename: Philipp
authors.initials: P
authors.lastname: Lange
authors.affiliation: Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Greif
authors.affiliation: 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.
authors.forename: Dario
authors.initials: D
authors.lastname: Bongiovanni
authors.affiliation: Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany.
authors.forename: Antonia
authors.initials: A
authors.lastname: Thaumann
authors.affiliation: Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Näbauer
authors.affiliation: Institut für Klinische Radiologie, Klinikum Großhadern, University Hospital of Munich, Munich, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Bischoff
authors.affiliation: Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Helbig
authors.affiliation: Institut für Klinische Radiologie, Klinikum Großhadern, University Hospital of Munich, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Becker
authors.affiliation: Herzchirurgische Klinik, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schmitz
authors.affiliation: Institut für Klinische Radiologie, Klinikum Großhadern, University Hospital of Munich, Munich, Germany.
authors.forename: Melvin
authors.initials: M
authors.lastname: D'Anastasi
authors.affiliation: 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.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.affiliation: Medizinische Klinik für Kardiologie und Angiologie, Helios Klinikum Siegburg, Siegburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Boekstegers
authors.affiliation: 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.
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.affiliation: 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.
authors.forename: Christian
authors.initials: C
authors.lastname: Kupatt
mesh_terms: D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000627:therapeutic use; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D008297:Male; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D013927:Thrombosis / Q000517:prevention & control*; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin