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ISAR-REACT 2 trial
Study characteristics:
1) multicenter, randomized, double-blind, placebo-controlled
2) 2202 patients
Treatment groups:*
1) abciximab 0.25 mg/kg bolus, then 0.125 ug/kg/minute for 12 hours + 70 U/kg heparin
2) placebo
* pretreatment of both groups with 600 mg of clopidogrel
Primary endpoint:
- composite
a) death
b) myocardial infarction
c) revascularization within 30 days
Results:
1) endpoint reached less often in abciximab group vs placebo (8.9% vs. 11.9%) {25% relative risk reduction}
2) relative risk reduction of 29% of insubset of patients with elevated troponin levels
3) no risk reduction without elevated troponin
4) no significant differences in risk for major bleeding abciximab vs placebo (1.4% and 1.4%)
5) risk for minor bleeding (4.2% vs 3.3%)
6) need for transfusion (2.5% vs 2.0%)
General
clinical trial
References
- Kastrati A, Mehilli J, Neumann FJ, Dotzer F,
ten Berg J, Bollwein H, Graf I, Ibrahim M, Pache J,
Seyfarth M, Schuhlen H, Dirschinger J, Berger PB, Schomig A;
Intracoronary Stenting and Antithrombotic: Regimen Rapid
Early Action for Coronary Treatment 2 (ISAR-REACT 2) Trial
Investigators.
Abciximab in patients with acute coronary syndromes undergoing
percutaneous coronary intervention after clopidogrel
pretreatment: the ISAR-REACT 2 randomized trial.
JAMA. 2006 Apr 5;295(13):1531-8. Epub 2006 Mar 13.
PMID: 16533938
- Steinhubl SR, Charnigo R.
Clopidogrel treatment prior to percutaneous coronary
intervention: when enough isn't enough.
JAMA. 2006 Apr 5;295(13):1581-2. Epub 2006 Mar 13. No abstract available.
PMID: 16533936