PMID- 26211708
OWN - NLM
STAT- MEDLINE
DCOM- 20151020
LR  - 20161125
IS  - 1916-7075 (Electronic)
IS  - 0828-282X (Linking)
VI  - 31
IP  - 8
DP  - 2015 Aug
TI  - Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve 
      Implantation.
PG  - 998-1003
LID - S0828-282X(15)00154-3 [pii]
LID - 10.1016/j.cjca.2015.02.029 [doi]
AB  - 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.
CI  - Copyright (c) 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All 
      rights reserved.
FAU - Lange, Philipp
AU  - Lange P
AD  - Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital 
      of Munich, Munich, Germany. Electronic address: 
      philipp.lange@med.uni-muenchen.de.
FAU - Greif, Martin
AU  - Greif M
AD  - Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital 
      of Munich, Munich, Germany.
FAU - Bongiovanni, Dario
AU  - Bongiovanni D
AD  - 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.
FAU - Thaumann, Antonia
AU  - Thaumann A
AD  - Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital 
      of Munich, Munich, Germany.
FAU - Nabauer, Michael
AU  - Nabauer M
AD  - Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital 
      of Munich, Munich, Germany.
FAU - Bischoff, Bernhard
AU  - Bischoff B
AD  - Institut fur Klinische Radiologie, Klinikum Grosshadern, University Hospital of 
      Munich, Munich, Germany.
FAU - Helbig, Susanne
AU  - Helbig S
AD  - Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital 
      of Munich, Munich, Germany.
FAU - Becker, Christoph
AU  - Becker C
AD  - Institut fur Klinische Radiologie, Klinikum Grosshadern, University Hospital of 
      Munich, Munich, Germany.
FAU - Schmitz, Christoph
AU  - Schmitz C
AD  - Herzchirurgische Klinik, Klinikum Grosshadern, University Hospital of Munich, 
      Munich, Germany.
FAU - D'Anastasi, Melvin
AU  - D'Anastasi M
AD  - Institut fur Klinische Radiologie, Klinikum Grosshadern, University Hospital of 
      Munich, Munich, Germany.
FAU - Mehilli, Julinda
AU  - Mehilli J
AD  - 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.
FAU - Boekstegers, Peter
AU  - Boekstegers P
AD  - Medizinische Klinik fur Kardiologie und Angiologie, Helios Klinikum Siegburg, 
      Siegburg, Germany.
FAU - Massberg, Steffen
AU  - Massberg S
AD  - 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.
FAU - Kupatt, Christian
AU  - Kupatt C
AD  - 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.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20150226
PL  - England
TA  - Can J Cardiol
JT  - The Canadian journal of cardiology
JID - 8510280
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged, 80 and over
MH  - Anticoagulants/therapeutic use
MH  - Antithrombins/therapeutic use
MH  - Aortic Valve Stenosis/*surgery
MH  - Female
MH  - Follow-Up Studies
MH  - Heparin/*therapeutic use
MH  - Hirudins
MH  - Humans
MH  - Male
MH  - Peptide Fragments/*therapeutic use
MH  - Recombinant Proteins/therapeutic use
MH  - Retrospective Studies
MH  - Thrombosis/*prevention & control
MH  - *Transcatheter Aortic Valve Replacement
MH  - Treatment Outcome
EDAT- 2015/07/28 06:00
MHDA- 2015/10/21 06:00
CRDT- 2015/07/28 06:00
PHST- 2015/01/04 00:00 [received]
PHST- 2015/02/19 00:00 [revised]
PHST- 2015/02/19 00:00 [accepted]
PHST- 2015/07/28 06:00 [entrez]
PHST- 2015/07/28 06:00 [pubmed]
PHST- 2015/10/21 06:00 [medline]
AID - S0828-282X(15)00154-3 [pii]
AID - 10.1016/j.cjca.2015.02.029 [doi]
PST - ppublish
SO  - Can J Cardiol. 2015 Aug;31(8):998-1003. doi: 10.1016/j.cjca.2015.02.029. Epub 
      2015 Feb 26.