Holger Thiele1, Steffen Desch2, Jan J Piek3, Janina Stepinska4, Keith Oldroyd5, Pranas Serpytis6, Gilles Montalescot7, Marko Noc8, Kurt Huber9, Georg Fuernau2, Suzanne de Waha2, Roza Meyer-Saraei2, Steffen Schneider10, Stephan Windecker11, Stefano Savonitto12, Andrew Briggs13, Patrizia Torremante14, Christiaan Vrints15, Gerhard Schuler16, Uta Ceglarek17, Joachim Thiery17, Uwe Zeymer18. 1. University Heart Center Luebeck, Luebeck, Germany; German Center for Cardiovascular Research (DZHK), Luebeck, Germany. Electronic address: holger.thiele@uksh.de. 2. University Heart Center Luebeck, Luebeck, Germany; German Center for Cardiovascular Research (DZHK), Luebeck, Germany. 3. Academic Medical Center, Amsterdam, The Netherlands. 4. Institute of Cardiology, Warsaw, Poland. 5. Western Infirmary, Glasgow, UK. 6. Vilnius University Hospital, Vilnius, Lithuania. 7. ACTION study group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France. 8. University Medical Center Ljubljana, Ljubljana, Slovenia. 9. Wilhelminenspital der Stadt Wien, Vienna, Austria. 10. Institut für Herzinfarktforschung, Ludwigshafen, Germany. 11. University of Bern, Inselspital, Bern, Switzerland. 12. Manzoni Hospital, Lecco, Italy. 13. Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK. 14. GABO:milliarium mbH & Co KG, Munich, Germany. 15. Universitair Ziekenhuis Antwerp, Antwerp, Belgium. 16. University of Leipzig-Heart Center, Leipzig, Germany. 17. University of Leipzig-Institute of Laboratory Medicine, Leipzig, Germany. 18. Institut für Herzinfarktforschung, Ludwigshafen, Germany; Klinikum Ludwigshafen, Ludwigshafen, Germany.
Abstract
BACKGROUND: In 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 DESIGN: The 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. CONCLUSIONS: The CULPRIT-SHOCK trial will address the question of optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by CS.
RCT Entities:
BACKGROUND: In 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 DESIGN: The 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. CONCLUSIONS: The CULPRIT-SHOCK trial will address the question of optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by CS.