Multivessel versus culprit lesion only percutaneous revascularization in patients with acute myocardial infarction complicated by cardiogenic shock
Coordinator: Holger THIELE
Project Number: 602202
EC contribution: € 5,999,145.00
Project website: under construction
Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) represents a major European health care concern with mortality rates between 40-70%. Approximately 70-80% of these patients present with multivessel disease defined as coronary lesions in more than one vessel.
The clinician is faced with the decision to either
- intervene only on the culprit lesion acutely responsible for the initiation of cardiogenic shock, or
- treat additional lesions considered hemodynamically significant but not acutely triggering the CS cascade as well.
Current guidelines recommend percutaneous coronary intervention of all critical lesions. However, due to a lack of randomized trials, these recommendations are solely based on registry data and pathophysiological considerations.
Aim of the randomized CULPRIT-SHOCK trial is therefore to compare
- immediate multivessel PCI versus
- culprit lesion only PCI in patients with AMI complicated by CS.
A total of 706 CS patients will be randomized in several European countries. The primary endpoint will be 30-day all-cause mortality and/or severe renal failure requiring renal replacement therapy. CULPRIT-SHOCK will therefore determine the optimal percutaneous revascularization strategy in patients with AMI and multivessel disease complicated by CS. In addition, a comprehensive array of efficacy, safety and socio-economic parameters for the chosen population will be assessed.
Multiple secondary endpoints and several substudies (microcirculation, biomarkers, angiography) will serve to further understand the presumed differential effects of the 2 treatment arms and to understand the underlying pathophysiology and prognostic markers. From these parameters a multivariable regression model and a risk score for the prediction of clinical prognosis and a cost-effectiveness model in AMI and CS will be developed. Furthermore, CULPRIT-SHOCK will obtain data on CS patients not meeting inclusion criteria by instituting a separate registry.