PMID- 20805113
OWN - NLM
STAT- MEDLINE
DCOM- 20110930
LR  - 20181201
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 31
IP  - 20
DP  - 2010 Oct
TI  - ISAR-REACT 3A: a study of reduced dose of unfractionated heparin in biomarker 
      negative patients undergoing percutaneous coronary intervention.
PG  - 2482-91
LID - 10.1093/eurheartj/ehq330 [doi]
AB  - AIMS: Although a 140 U/kg dose of unfractionated heparin (UFH) was comparable 
      with bivalirudin in terms of net clinical outcome in the Intracoronary Stenting 
      and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 
      (ISAR-REACT) 3 trial, it was associated with a higher risk of bleeding. We 
      designed this study to assess whether a reduction in the UFH dose from 140 to 100 
      U/kg is associated with improved net clinical outcome. METHODS AND RESULTS: A 
      total of 2505 biomarker negative patients undergoing percutaneous coronary 
      intervention (PCI) after clopidogrel pre-treatment received a single bolus of 100 
      U/kg UFH. The primary endpoint was net clinical outcome-a quadruple endpoint of 
      death, myocardial infarction, urgent target-vessel revascularization within 30 
      days, or in-hospital REPLACE 2 defined major bleeding. The primary comparison was 
      with the historical UFH group of ISAR-REACT 3 (2281 patients). In a second 
      analysis, we checked for non-inferiority against the historical bivalirudin arm 
      of ISAR-REACT 3 (2289 patients). The incidence of the primary endpoint was 7.3% 
      in the lower UFH dose group compared with 8.7% in the higher UFH dose group 
      [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67-1.00; P = 0.045]. The 
      incidence of major bleeding was 3.6% in the lower UFH dose group and 4.6% in the 
      higher UFH dose group (HR 0.79; 95% CI 0.59-1.05; P = 0.11). The lower UFH dose 
      met the criterion of non-inferiority compared with bivalirudin (P < 0.001). 
      CONCLUSION: In biomarker negative patients undergoing PCI after clopidogrel 
      loading, a reduced dose of 100 U/kg UFH provided net clinical benefit compared 
      with the historical control of 140 U/kg UFH in the ISAR-REACT 3 trial. The 
      benefit was mostly driven by reduction in bleeding. CLINICAL TRIAL REGISTRATION 
      INFORMATION: URL www.clinicaltrials.gov; Unique identifier NCT00735280.
FAU - Schulz, Stefanie
AU  - Schulz S
AD  - Deutsches Herzzentrum Munchen, Technische Universitat, Lazarettstr. 36, 80636 
      Munich, Germany. schulzs@dhm.mhn.de
FAU - Mehilli, Julinda
AU  - Mehilli J
FAU - Neumann, Franz-Josef
AU  - Neumann FJ
FAU - Schuster, Tibor
AU  - Schuster T
FAU - Massberg, Steffen
AU  - Massberg S
FAU - Valina, Christian
AU  - Valina C
FAU - Seyfarth, Melchior
AU  - Seyfarth M
FAU - Pache, Jurgen
AU  - Pache J
FAU - Laugwitz, Karl-Ludwig
AU  - Laugwitz KL
FAU - Buttner, Hans-Joachim
AU  - Buttner HJ
FAU - Ndrepepa, Gjin
AU  - Ndrepepa G
FAU - Schomig, Albert
AU  - Schomig A
FAU - Kastrati, Adnan
AU  - Kastrati A
CN  - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for 
      Coronary Treatment (ISAR-REACT) 3A Trial Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00735280
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100830
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
RN  - 0 (Anticoagulants)
RN  - 0 (Biomarkers)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 9005-49-6 (Heparin)
RN  - A74586SNO7 (Clopidogrel)
RN  - OM90ZUW7M1 (Ticlopidine)
SB  - IM
CIN - Eur Heart J. 2010 Oct;31(20):2447-8. PMID: 20876067
MH  - Aged
MH  - Angina Pectoris/*therapy
MH  - Angioplasty, Balloon, Coronary
MH  - Anticoagulants/*administration & dosage
MH  - Biomarkers
MH  - Clopidogrel
MH  - Death, Sudden, Cardiac/prevention & control
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Heparin/*administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/prevention & control
MH  - Myocardial Revascularization
MH  - Platelet Aggregation Inhibitors/administration & dosage
MH  - Postoperative Hemorrhage/prevention & control
MH  - Prospective Studies
MH  - Ticlopidine/administration & dosage/analogs & derivatives
MH  - Treatment Outcome
EDAT- 2010/09/02 06:00
MHDA- 2011/10/01 06:00
CRDT- 2010/09/01 06:00
PHST- 2010/09/01 06:00 [entrez]
PHST- 2010/09/02 06:00 [pubmed]
PHST- 2011/10/01 06:00 [medline]
AID - ehq330 [pii]
AID - 10.1093/eurheartj/ehq330 [doi]
PST - ppublish
SO  - Eur Heart J. 2010 Oct;31(20):2482-91. doi: 10.1093/eurheartj/ehq330. Epub 2010 
      Aug 30.