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European Heart Journal Advance Access published online on October 7, 2005

European Heart Journal, doi:10.1093/eurheartj/ehi590
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received May 20, 2005
Revised September 15, 2005
Accepted September 22, 2005

Clinical research

Direct thrombin inhibitors in acute coronary syndromes: effect in patients undergoing early percutaneous coronary intervention

Peter R. Sinnaeve 1*, John Simes 2, Salim Yusuf 3, Jyotsna Garg 4, Shamir Mehta 3, John Eikelboom 5, John A. Bittl 6, Patrick Serruys 7, Eric J. Topol 8, and Christopher B. Granger 4

1 Duke Clinical Research Center, Durham, NC, USA; Department of Cardiology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium
2 NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia
3 Department of Cardiology, Population Health Research Institute, McMaster University, Hamilton, Ont., Canada
4 Duke Clinical Research Center, Durham, NC, USA
5 Department of Medicine, McMaster University, Hamilton, Ont., Canada
6 Ocala Heart Institute, Munroe Regional Medical Center, Ocala, FL, USA
7 Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands
8 Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, OH, USA

* To whom correspondence should be addressed.
Peter R. Sinnaeve, E-mail: peter.sinnaeve{at}uz.kuleuven.ac.be


   Abstract

Aims We evaluated the effect of direct thrombin inhibitors (DTIs) in patients undergoing early percutaneous coronary intervention (PCI), using the DTI Trialists' Collaboration database of 35 970 patients from 11 randomized trials of DTIs vs. heparin.

Methods and results We performed a Cox proportional hazards regression analysis with PCI as a time-dependent covariate to assess the independent impact of DTIs according to the performance of early PCI. PCI was performed in 7049 patients in the first 72 h after randomization. In trials in which PCI was not planned, DTIs were associated with a 10% relative risk reduction in death or myocardial infarction at 30 days (HR = 0.90, 95% CI: 0.84-0.97). This benefit was found to be greater in patients undergoing early PCI (HR = 0.66, 95% CI: 0.48-0.91) than those undergoing non-early PCI (HR = 0.94, 95% CI: 0.86-1.03). After adjustment for baseline characteristics and propensity to undergo PCI, the risk of death or myocardial infarction remained lower with DTI (HR = 0.62, 95% CI: 0.44-0.89).

Conclusion After adjustment for baseline differences and propensity to undergo early PCI, DTIs appeared to be more effective than heparin in reducing death or re-infarction among patients undergoing early PCI.

Keywords: Direct thrombin inhibitors; Percutaneous coronary intervention; Acute coronary syndromes.
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