Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI)
Background
Most patients with ST-elevation myocardial infarction present to hospitals without percutaneous coronary intervention (PCI) facilities and receive fibrinolysis. The role of routine early PCI after fibrinolysis, using stents and contemporary pharmacotherapy, has not been studied in a large adequately powered randomized trial.
Objective
To compare a pharmacoinvasive strategy of transfer for routine PCI within 6 hours after fibrinolysis with standard treatment after fibrinolysis (including predefined criteria for rescue PCI and delayed cardiac catheterization for patients who do not require rescue PCI).
Methods
A total of 1200 patients with high-risk ST-elevation myocardial infarction presenting to non-PCI centers will be randomized to a pharmacoinvasive strategy (transfer for routine PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis. The primary end point is the 30-day composite of death, reinfarction, recurrent ischemia, heart failure, or shock.
Results
More than 900 patients have been enrolled as of April 2007. An interim safety analysis of the first 536 patients demonstrated no safety concerns. Enrolment is expected to be completed in late 2007.
Conclusions
This study will provide important data on whether routine early PCI within 6 hours after fibrinolysis is safe and superior to the standard treatment of fibrinolysis with rescue PCI or delayed cardiac catheterization.
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This study was supported by a grant from the Canadian Institutes of Health Research and an unrestricted grant from Hoffman La Roche, Canada.
Dr Warren Cantor has received consulting fees, speaker's honoraria, and unrestricted research grants from Hoffman La Roche Canada and from Sanofi-Aventis.
Dr Laurie Morrison has received speaker's honoraria from Hoffman La Roche and unrestricted research grants from Sanofi-Aventis.
Dr Shaun Goodman has received consulting fees, speaker's honoraria, and research grants from Boehringer Ingelheim, Hoffmann La Roche, and Sanofi-Aventis.
Dr Eric Cohen has received consulting fees and speaker's honoraria from Hoffman La Roche Canada and from Sanofi-Aventis.
Dr David Fitchett has received consulting fees and speaker's honoraria from Hoffman La Roche, Bristol-Myers-Squibb, and Sanofi-Aventis.
Dr David Fitchett has received consulting fees and speaker's honoraria from Hoffman La Roche, Bristol-Myers-Squibb, and Sanofi-Aventis
Dr Bjug Borgundvaag has received consulting fees, speaker's honoraria and/or unrestricted research grants from Hoffman La Roche Canada, Sanofi-Aventis, and Key Pharmaceuticals.
Dr Shamir Mehta has received consulting fees and/or speaker's honoraria and/or unrestricted research grants from Sanofi-Aventis, Bristol-Myers-Squibb, Astra Zeneca, Eli Lilly, Boston Scientific, GlaxoSmithKline, Oryx Pharmaceuticals, Abbott, Johnson and Johnson.
Dr Michael Heffernan has received speaker's honoraria from Sanofi-Aventis.
Dr Anatoly Langer has received consulting fees and/or speaker's honoraria and/or unrestricted research grants from Hoffman La Roche Canada, Astra Zeneca, Bayer, Biovail, BMS, Boston Scientific, Cordis (J&J), DuPont, Eli Lilly, Fournier, GlaxoSmithKline, Guidant, Medtronic, Merck Schering, Novartis, Oryx, Pfizer, Sanofi-Aventis, and Servier.
PII: S0002-8703(07)00711-9
doi:10.1016/j.ahj.2007.08.025
© 2008 Mosby, Inc. All rights reserved.
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