CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization
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
* Duke Clinical Research Institute, Durham, North Carolina
Deutsches Herzzentrum, Munich, Germany
University of Kentucky School of Medicine, Lexington, Kentucky
Mediziniche Klinik I, Garmisch-Partenkirchen, Germany
|| St. Antonius Ziekenhuis, Nieuwegein, the Netherlands
¶ Herz-Zentrum, Bad Krozingen, Germany
# 1. Medizinische Klinik rechts der Isar, Munich, Germany
Manuscript received July 6, 2004;
accepted August 23, 2004.
* Reprint requests and correspondence: Dr. David E. Kandzari, Room 7063, Duke Clinical Research Institute, Durham, North Carolina 27705 (Email: kandz002{at}mc.duke.edu).
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.
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Abbreviations and Acronyms
| | CREDO = Clopidogrel for the Reduction of Events During Observation trial | | GP = glycoprotein | | ISAR-REACT = Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment trial | | MI = myocardial infarction | | PCI = percutaneous coronary intervention | | ULN = upper limit of normal |
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