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American heart journal · Feb 2016
Randomized Controlled Trial Multicenter StudyMultivessel versus culprit lesion only percutaneous revascularization plus potential staged revascularization in patients with acute myocardial infarction complicated by cardiogenic shock: Design and rationale of CULPRIT-SHOCK trial.
- Holger Thiele, Steffen Desch, Jan J Piek, Janina Stepinska, Keith Oldroyd, Pranas Serpytis, Gilles Montalescot, Marko Noc, Kurt Huber, Georg Fuernau, Suzanne de Waha, Roza Meyer-Saraei, Steffen Schneider, Stephan Windecker, Stefano Savonitto, Andrew Briggs, Patrizia Torremante, Christiaan Vrints, Gerhard Schuler, Uta Ceglarek, Joachim Thiery, Uwe Zeymer, and CULPRIT-SHOCK Investigators.
- University Heart Center Luebeck, Luebeck, Germany; German Center for Cardiovascular Research (DZHK), Luebeck, Germany. Electronic address: holger.thiele@uksh.de.
- Am. Heart J. 2016 Feb 1; 172: 160-9.
BackgroundIn acute myocardial infarction complicated by cardiogenic shock (CS), up to 80% of patients present with multivessel coronary artery disease. Currently, the best revascularization strategy is unknown. Therefore, a prospective randomized adequately powered clinical trial is warranted.Study DesignThe CULPRIT-SHOCK study is a 706-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare culprit lesion only percutaneous coronary intervention (PCI) with possible staged non-culprit lesion revascularization versus immediate multivessel PCI in patients with CS complicating acute myocardial infarction. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of CULPRIT-SHOCK is 30-day mortality and severe renal failure requiring renal replacement therapy. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, an intermediate- and long-term follow-up at 6 and 12 months will be performed. Safety endpoints include the assessment of bleeding and stroke.ConclusionsThe CULPRIT-SHOCK trial will address the question of optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by CS.Copyright © 2015 Elsevier Inc. All rights reserved.
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