Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction - 06/08/11
, Akiko Maehara, MD b, j, Alexandra J. Lansky, MD b, j, Jochen Wohrle, MD c, j, Tom Stuckey, MD d, j, Rajesh Dave, MD e, j, David Cox, MD f, j, Cindy Grines, MD g, j, Dariusz Dudek, MD h, j, Gabriel Steg, MD i, j, Helen Parise, ScD i, j, Steven D. Wolff, MD, PhD b, j, Ecaterina Cristea, MD b, j, Gregg W. Stone, MD b, jRésumé |
Background |
Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies.
Design |
INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid–left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding.
Summary |
INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.
Le texte complet de cet article est disponible en PDF.Plan
| Mauricio G. Cohen, MD served as guest editor for this article. |
|
| Clinical trial registration:ClinicalTrials.gov no. NCT00976521. |
Vol 161 - N° 3
P. 478 - mars 2011 Retour au numéro
Article précédent
- The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol : Rationale and study design. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH)
- The AIM-HIGH Investigators a b ?
- Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy
- Barry Trachtenberg, Darcy L. Velazquez, Adam R. Williams, Ian McNiece, Joel Fishman, Kim Nguyen, Didier Rouy, Peter Altman, Richard Schwarz, Adam Mendizabal, Behzad Oskouei, John Byrnes, Victor Soto, Melissa Tracy, Juan Pablo Zambrano, Alan W. Heldman, Joshua M. Hare
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?