PMID- 25772138
OWN - NLM
STAT- MEDLINE
DCOM- 20160125
LR  - 20220309
IS  - 1879-2472 (Electronic)
IS  - 0049-3848 (Linking)
VI  - 135
IP  - 5
DP  - 2015 May
TI  - Bivalirudin as compared to unfractionated heparin in patients undergoing 
      percutaneous coronary revascularization: A meta-analysis of 22 randomized trials.
PG  - 902-15
LID - S0049-3848(15)00110-3 [pii]
LID - 10.1016/j.thromres.2015.03.004 [doi]
AB  - Bivalirudin has gained ground against unfractionated heparin (UFH) in 
      percutaneous coronary interventions (PCI), due to a reported better safety 
      profile. However, whether bivalirudin may provide also advantages in clinical 
      outcome beyond the known benefits in major bleedings, is still a debated matter 
      and was, therefore, the aim of present meta-analysis of randomized trials, 
      evaluating efficacy and safety of bivalirudin as compared with UFH in PCI. 
      METHODS AND STUDY OUTCOMES: Literature archives (Pubmed, EMBASE, Cochrane) and 
      main scientific sessions were scanned. Primary endpoint was overall mortality. 
      Secondary endpoints were: 1) mortality within 30-days; 2) overall and within 
      30-days non fatal myocardial infarction; 3) overall and within 30-days stent 
      thrombosis. Safety endpoints were major bleedings (per protocol definition or 
      TIMI classification). A prespecified analysis was conducted according to clinical 
      presentation (Elective, ACS, STEMI). RESULTS: A total of 22 randomized clinical 
      were finally included, involving 40156 patients randomized to bivalirudin (52.9%) 
      or to UFH (47.1%). Death occurred in 1100 (2.8%) of patients, with no difference 
      between bivalirudin and UFH (2.7% vs 2.8% OR[95%C]=0.94[0.83,-.06], p=0.32, 
      phet=0.48). The results did not change according to clinical presentation. By 
      meta-regression analysis, the effects on mortality were not related to patients 
      risk profile (r=-0.38(-0.89-0.14), p=0.15) or the reduction in bleeding 
      complications (r=-0.008(-0.86-0.85), p=0.98). A significant increase in 
      short-term stent thrombosis was observed with bivalirudin (OR[95%CI]=1.42 
      [1.10-1.83], p=0.006). However, Bivalirudin significantly reduced bleedings 
      according to both study protocol definition (OR[95%CI]=0.62[0.56-0.69],p<0.00001; 
      phet=0.0003) or TIMI major criteria (OR[95%CI]=0.65[0.53-0.79],p<0.0001, 
      phet=0.95). CONCLUSIONS: In present meta-analysis, among patients undergoing PCI, 
      bivalirudin, as compared with UFH, is associated with a significant reduction in 
      major bleeding complications that, however, does not translate into mortality 
      benefits. Furthermore, bivalirudin is associated with higher rate of 30-days 
      stent thrombosis and recurrent MI among STEMI patients.
CI  - Copyright (c) 2015 Elsevier Ltd. All rights reserved.
FAU - Verdoia, Monica
AU  - Verdoia M
AD  - Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della 
      Carita", Eastern Piedmont University, Novara, Italy.
FAU - Schaffer, Alon
AU  - Schaffer A
AD  - Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della 
      Carita", Eastern Piedmont University, Novara, Italy.
FAU - Barbieri, Lucia
AU  - Barbieri L
AD  - Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della 
      Carita", Eastern Piedmont University, Novara, Italy.
FAU - Suryapranata, Harry
AU  - Suryapranata H
AD  - Department of Cardiology, UMC St Radboud, Nijmegen, The Netherlands.
FAU - De Luca, Giuseppe
AU  - De Luca G
AD  - Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della 
      Carita", Eastern Piedmont University, Novara, Italy. Electronic address: 
      giuseppe.deluca@med.unipmn.it.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20150308
PL  - United States
TA  - Thromb Res
JT  - Thrombosis research
JID - 0326377
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Anticoagulants/*therapeutic use
MH  - Hemorrhage/prevention & control
MH  - Heparin/*therapeutic use
MH  - Hirudins
MH  - Humans
MH  - Peptide Fragments/*therapeutic use
MH  - *Percutaneous Coronary Intervention/adverse effects/methods
MH  - Randomized Controlled Trials as Topic
MH  - Recombinant Proteins/therapeutic use
MH  - Thrombosis/drug therapy/epidemiology
OTO - NOTNLM
OT  - Bivalirudin
OT  - Heparin
OT  - Meta-analysis
OT  - Outcome
OT  - Percutaneous coronary intervention
EDAT- 2015/03/17 06:00
MHDA- 2016/01/26 06:00
CRDT- 2015/03/17 06:00
PHST- 2014/07/29 00:00 [received]
PHST- 2015/01/19 00:00 [revised]
PHST- 2015/03/03 00:00 [accepted]
PHST- 2015/03/17 06:00 [entrez]
PHST- 2015/03/17 06:00 [pubmed]
PHST- 2016/01/26 06:00 [medline]
AID - S0049-3848(15)00110-3 [pii]
AID - 10.1016/j.thromres.2015.03.004 [doi]
PST - ppublish
SO  - Thromb Res. 2015 May;135(5):902-15. doi: 10.1016/j.thromres.2015.03.004. Epub 
      2015 Mar 8.