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

Am Heart J. 2016 Feb;172:160-9. doi: 10.1016/j.ahj.2015.11.006. Epub 2015 Dec 1.

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.

Trial registration: ClinicalTrials.gov NCT01927549.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Coronary Angiography
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / surgery*
  • Electrocardiography*
  • Europe / epidemiology
  • Humans
  • Myocardial Infarction / diagnosis
  • Myocardial Infarction / mortality
  • Myocardial Infarction / surgery*
  • Percutaneous Coronary Intervention / methods*
  • Prognosis
  • Prospective Studies
  • Shock, Cardiogenic / etiology*
  • Shock, Cardiogenic / mortality
  • Shock, Cardiogenic / surgery
  • Survival Rate / trends
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01927549