Holger Thiele1, Ibrahim Akin1, Marcus Sandri1, Suzanne de Waha-Thiele1, Roza Meyer-Saraei1, Georg Fuernau1, Ingo Eitel1, Peter Nordbeck1, Tobias Geisler1, Ulf Landmesser1, Carsten Skurk1, Andreas Fach1, Alexander Jobs1, Harald Lapp1, Jan J Piek1, Marko Noc1, Tomaž Goslar1, Stephan B Felix1, Lars S Maier1, Janina Stepinska1, Keith Oldroyd1, Pranas Serpytis1, Gilles Montalescot1, Olivier Barthelemy1, Kurt Huber1, Stephan Windecker1, Lukas Hunziker1, Stefano Savonitto1, Patrizia Torremante1, Christiaan Vrints1, Steffen Schneider1, Uwe Zeymer1, Steffen Desch1. 1. From Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig (H.T., M.S., A.J., S.D.), Universitätsmedizin Mannheim, Mannheim (I.A.), University Heart Center Lübeck, Lübeck (S.W.-T., R.M.-S., G.F., I.E.), German Center for Cardiovascular Research (I.A., S.W.-T., R.M.-S., G.F., I.E., U.L., C.S., A.J., S.B.F., S.D.) and Universitätsklinikum Charité, Campus Benjamin Franklin (U.L., C.S.), Berlin, Universitätsklinikum Würzburg, Würzburg (P.N.), Klinikum der Eberhard-Karls-Universität Tübingen, Tübingen (T. Geisler), Klinikum Links der Weser, Bremen (A.F.), Helios Klinik Erfurt, Erfurt (H.L.), Ernst-Moritz-Arndt-Universität, Greifswald (S.B.F.), Universitäres Herzzentrum Regensburg, Regensburg (L.S.M.), and Institut für Herzinfarktforschung (S. Schneider, U.Z.) and Klinikum Ludwigshafen (U.Z.), Ludwigshafen - all in Germany; Academic Medical Center, Amsterdam (J.J.P.); University Medical Center Ljubljana, Ljubljana, Slovenia (M.N., T. Goslar); Institute of Cardiology, Warsaw, Poland (J.S.); Golden Jubilee National Hospital, Glasgow, United Kingdom (K.O.); Vilnius University Hospital Santaros Klinikos and Faculty of Medicine, Vilnius University, Vilnius, Lithuania (P.S.); Sorbonne Université Paris 6, ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière (G.M., O.B.), and Applied Research, Technology Transfer, Industrial Collaboration, Société par Actions Simplifiée (P.T.), Paris; Wilhelminenpital, Department of Cardiology, and Sigmund Freud University, Medical School, Vienna (K.H.); the Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland (S.W., L.H.); Manzoni Hospital, Lecco, Italy (S. Savonitto); and Universitair Ziekenhuis Antwerp, Antwerp, Belgium (C.V.).
Abstract
BACKGROUND: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year. METHODS: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure. RESULTS: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04). CONCLUSIONS: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).
RCT Entities:
BACKGROUND: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year. METHODS: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure. RESULTS: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04). CONCLUSIONS: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).
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