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.

Thiele, Holger; Desch, Steffen; Piek, Jan J; Stepinska, Janina; Oldroyd, Keith; Serpytis, Pranas; Montalescot, Gilles; Noc, Marko; Huber, Kurt; Fuernau, Georg; de Waha, Suzanne; Meyer-Saraei, Roza; Schneider, Steffen; Windecker, Stephan; Savonitto, Stefano; Briggs, Andrew; Torremante, Patrizia; Vrints, Christiaan; Schuler, Gerhard; Ceglarek, Uta; ... (2016). 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. American Heart Journal, 172, pp. 160-169. Elsevier 10.1016/j.ahj.2015.11.006

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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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