PMID- 15282655
OWN - NLM
STAT- MEDLINE
DCOM- 20050131
LR  - 20161124
IS  - 0094-6176 (Print)
IS  - 0094-6176 (Linking)
VI  - 30
IP  - 3
DP  - 2004 Jun
TI  - Bivalirudin in PCI: an overview of the REPLACE-2 trial.
PG  - 329-36
AB  - The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events 
      (REPLACE)-2 trial is one of the largest acute randomized controlled trials 
      evaluating the efficacy of two anticoagulant strategies during contemporary 
      urgent or elective percutaneous coronary intervention (PCI). The direct thrombin 
      inhibitor, bivalirudin, with provisional use of glycoprotein IIb/IIIa (GP 
      IIb/IIIa) inhibitor was compared to low-dose unfractionated heparin (UFH) plus 
      planned GP IIb/IIIa inhibitor. At 30-day follow-up, the primary quadruple 
      composite endpoint (death, myocardial infarction (MI), urgent repeat 
      revascularization, or in-hospital major bleeding) occurred in 9.2% of patients in 
      the bivalirudin group versus 10.0% of patients in the UFH plus GP IIb/IIIa 
      inhibitor group. The secondary triple composite endpoint (death, MI, urgent 
      repeat revascularization) occurred in 7.6% of patients in the bivalirudin group 
      compared with 7.1% of patients in the UFH plus GP IIb/IIIa inhibitor group. Both 
      endpoints met formal statistical criteria for noninferiority to UFH plus GP 
      IIb/IIIa inhibitor. By imputed comparison from historic GP IIb/IIIa trials 
      between bivalirudin versus UFH alone, REPLACE-2 demonstrated that bivalirudin was 
      superior to UFH alone with respect to the quadruple and triple composite 
      endpoints. Furthermore, bivalirudin plus provisional GP IIb/IIIa blockade was 
      associated with a significant reduction in in-hospital bleeding (2.4% vs. 4.1%; p 
      < 0.001). At 6 months' follow-up, there was no significant difference in rates of 
      death, MI, or revascularization between the two groups. Furthermore, there was no 
      evidence that the early, nonsignificant 0.5% excess non-Q-wave MI in the 
      bivalirudin group translated into later mortality. There was a trend toward 
      decreased mortality at 6 months in the bivalirudin arm (0.95% vs. 1.35%; p = 
      0.148). The relative efficacy of bivalirudin versus UFH plus GP IIb/IIIa 
      inhibitor was similar in several high-risk subgroups, including patients with 
      diabetes mellitus or prior MI, women, the elderly (age > 65 years), and patients 
      undergoing PCI of bypass grafts. Bivalirudin represents an exciting alternative 
      to UFH plus GP IIb/IIIa inhibitor in patients undergoing urgent and elective PCI 
      with similar suppression of ischemic events, fewer bleeding complications, and 
      the potential for greater cost savings and ease of administration.
FAU - Maroo, Anjli
AU  - Maroo A
AD  - Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, 
      Cleveland, Ohio 44195, USA. marooa@ccf.org
FAU - Lincoff, A Michael
AU  - Lincoff AM
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Semin Thromb Hemost
JT  - Seminars in thrombosis and hemostasis
JID - 0431155
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - EC 3.4.21.5 (Thrombin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticoagulants/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Double-Blind Method
MH  - Female
MH  - Heart Diseases/*drug therapy
MH  - Heparin/therapeutic use
MH  - Hirudins/*analogs & derivatives
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/*therapeutic use
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors
MH  - Recombinant Proteins/*therapeutic use
MH  - Thrombin/antagonists & inhibitors
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2004/07/30 05:00
MHDA- 2005/02/03 09:00
CRDT- 2004/07/30 05:00
PHST- 2004/07/30 05:00 [pubmed]
PHST- 2005/02/03 09:00 [medline]
PHST- 2004/07/30 05:00 [entrez]
AID - 10.1055/s-2004-831045 [doi]
PST - ppublish
SO  - Semin Thromb Hemost. 2004 Jun;30(3):329-36. doi: 10.1055/s-2004-831045.