Multivessel 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 - 06/02/16
, Steffen Desch, MD a, b, Jan J. Piek, MD, PhD c, Janina Stepinska, MD d, Keith Oldroyd, MD e, Pranas Serpytis, MD f, Gilles Montalescot, MD g, Marko Noc, MD h, Kurt Huber, MD i, Georg Fuernau, MD a, b, Suzanne de Waha, MD a, b, Roza Meyer-Saraei, PhD a, b, Steffen Schneider, PhD j, Stephan Windecker, MD k, Stefano Savonitto, MD l, Andrew Briggs, PhD m, Patrizia Torremante n, Christiaan Vrints, MD o, Gerhard Schuler, MD p, Uta Ceglarek, PhD q, Joachim Thiery, MD q, Uwe Zeymer, MD j, ron behalf of the
CULPRIT-SHOCK Investigators
Résumé |
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.
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| Clinical trial registration: Clinicaltrials.gov no. NCT01927549. |
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| Funding source: European Union; German Heart Research Foundation German Cardiac Society. |
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| Conflict of interest: No conflicts of interest to declare with respect to the current study. |
Vol 172
P. 160-169 - février 2016 Retour au numéro
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