Author + information
- Received July 6, 2004
- Accepted August 23, 2004
- Published online December 7, 2004.
- David E. Kandzari, MD*,* (, )
- Peter B. Berger, MD*,
- Adnan Kastrati, MD†,
- Steven R. Steinhubl, MD‡,
- Julinda Mehilli, MD†,
- Franz Dotzer, MD§,
- Jurriën M. ten Berg, MD∥,
- Franz-Josef Neumann, MD¶,
- Hildegard Bollwein, MD#,
- Josef Dirschinger, MD#,
- Albert Schömig, MD†,#,
- ISAR-REACT Study Investigators
- ↵*Reprint requests and correspondence:
Dr. David E. Kandzari, Room 7063, Duke Clinical Research Institute, Durham, North Carolina 27705
Objectives We examined clinical outcomes in the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment (ISAR-REACT) trial based on the duration of pretreatment with a 600-mg loading dose of clopidogrel.
Background The influence of the treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization on early outcomes remains uncertain.
Methods Among 2,159 patients with coronary disease who underwent percutaneous coronary intervention (PCI) in the ISAR-REACT trial, we examined clinical outcomes relative to the duration of pretreatment with a 600-mg dose of clopidogrel: (2 to 3 h, 3 to 6 h, 6 to 12 h, or >12 h). Patients were randomly assigned to adjunctive therapy with abciximab or placebo at the beginning of the study. The primary end point was a composite of death, myocardial infarction, or urgent revascularization within 30 days after randomization.
Results No significant differences were observed between patient groups regarding the duration of pretreatment, irrespective of assignment to abciximab or placebo (p = 0.27 for interaction among abciximab/clopidogrel and placebo/clopidogrel treatment at each time interval). Occurrence of major bleeding also did not differ according to time of initial clopidogrel dosing.
Conclusions For low-to-intermediate risk patients treated with a 600-mg loading dose of clopidogrel before PCI, incremental clinical benefit within the first 30 days from durations of pretreatment >2 to 3 h was not evident.
The ISAR-REACT trial was supported by research grants from Deutsches Herzzentrum, Klinik an der Technischen Universität, Munich, Germany (67-00 and 04-01), and by an unrestricted educational grant from Bristol-Myers Squibb GmbH, Munich, Germany.
- Received July 6, 2004.
- Accepted August 23, 2004.
- American College of Cardiology Foundation