SHould we emergently revascularise occluded coronaries for cardiogenic shocK: An international randomized trial of emergency PTCA/CABG-trial design

Background Cardiogenic shock (CS) is the leading cause of death in patients hospitalized with acute myocardial infarction (MI). Nonrandomized studies suggest reduced mortality rate with revascularization. Trial design The SHOCK trial is a multicenter, randomized, and unblinded st udy with a Registry for trial-eligible and ineligible nonrandomized patient s. The trial is testing the hypothesis that a direct invasive strategy of e mergency revascularization for patients with cardiogenic shock complicating acute MI will reduce 30-day all-cause mortality rate by 20 absolute percen tage points compared with initial medical stabilization. Eligibility criter ia include development of CS within 36 hours of an acute transmural MI as e videnced by ST elevation or new left bundle branch block MI; clinical crite ria for CS with hemodynamic confirmation; absence of a mechanical, iatrogen ic, or other cause of shock; and enrollment within 12 hours of CS diagnosis . Patients randomly assigned to emergency revascularization immediately und ergo coronary angiography, with percutaneous transluminal coronary angiopla sty or coronary artery bypass grafting depending on the coronary anatomy Pa tients assigned to initial medical stabilization may undergo revascularizat ion greater than or equal to 54 hours after randomization. End points The primary end point is all-cause 30-day mortality after random ization. Secondary end points include death at trial termination, changes i n left ventricular dimensions and function measured by echocardiography at randomization and 2 weeks later, and changes in quality of rife and physica l functioning from 2 weeks after discharge to 6 months after MI.