Elsevier

American Heart Journal

Volume 137, Issue 2, February 1999, Pages 313-321
American Heart Journal

SHould We Emergently Revascularize Occluded Coronaries for Cardiogenic ShocK: An international randomized trial of emergency PTCA/CABG—trial design,☆☆,,★★

https://doi.org/10.1053/hj.1999.v137.95352Get rights and content
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Abstract

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 study with a Registry for trial-eligible and ineligible nonrandomized patients. The trial is testing the hypothesis that a direct invasive strategy of emergency revascularization for patients with cardiogenic shock complicating acute MI will reduce 30-day all-cause mortality rate by 20 absolute percentage points compared with initial medical stabilization. Eligibility criteria include development of CS within 36 hours of an acute transmural MI as evidenced by ST elevation or new left bundle branch block MI; clinical criteria for CS with hemodynamic confirmation; absence of a mechanical, iatrogenic, or other cause of shock; and enrollment within 12 hours of CS diagnosis. Patients randomly assigned to emergency revascularization immediately undergo coronary angiography, with percutaneous transluminal coronary angioplasty or coronary artery bypass grafting depending on the coronary anatomy. Patients assigned to initial medical stabilization may undergo revascularization ≥54 hours after randomization. End Points The primary end point is all-cause 30-day mortality after randomization. Secondary end points include death at trial termination, changes in left ventricular dimensions and function measured by echocardiography at randomization and 2 weeks later, and changes in quality of life and physical functioning from 2 weeks after discharge to 6 months after MI. (Am Heart J 1999;137:313-21.)

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Study supported by R01 grants from the National Heart, Lung, and Blood Institute, #HL50020-018Z and HL49970, 1994-1999.

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Initial phase supported by a grant-in-aid from the American Heart Association New York Affiliate.

Reprint requests: Judith S. Hochman, MD, St Luke’s-Roosevelt Hospital, 1111 Amsterdam Ave, New York, NY 10025.E-mail: [email protected]

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0002-8703/99/$8.00 + 0   4/1/95352