Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial

French, John K; Feldman, Henry A; Assmann, Susan F; Sanborn, Timothy; Palmeri, Sebastian T; Miller, David; Boland, Jean; Buller, Christopher E; Steingart, Richard; Sleeper, Lynn A; Hochman, Judith S; SHOCK Investigators,

doi:10.1016/S0002-8703(03)00392-2

« Previous Next »American Heart Journal
Volume 146, Issue 5 , Pages 804-810, November 2003

Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial☆

Presented in part at the 72nd Scientific Sessions of the American Heart Association, Atlanta, Ga, November 1999.

John K French, MB, PhD
- Green Lane Hospital, Auckland, New Zealand
- Reprint requests: John French, MB, PhD, Department of Cardiology, Green Lane Hospital, Private Bag 92189, Auckland 1030, New Zealand.
Henry A Feldman, PhD
- New England Research Institutes, Watertown, Mass, USA
Susan F Assmann, PhD
- New England Research Institutes, Watertown, Mass, USA
Timothy Sanborn, MD
- Evanston Northwestern Healthcare, Division of Cardiology, Evanston, Ill, USA
Sebastian T Palmeri, MD
- University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ, USA
David Miller, MD
- Weill Medical College of Cornell University, New York, NY, USA
Jean Boland, MD
- Centre Hospitalier Regional Citadelle, Liège, Belgium
Christopher E Buller, MD
- Vancouver General Hospital, Vancouver, British Coulmbia, Canada
Richard Steingart, MD
- Winthrop University Hospital, Mineola, NY, USA
Lynn A Sleeper, ScD
- New England Research Institutes, Watertown, Mass, USA
Judith S Hochman, MD
- New York University School of Medicine, New York, NY, USA
SHOCK Investigators

Received 4 February 2002; accepted 21 March 2003.

Abstract

Background

The enhancement of diastolic coronary blood flow by the combination of thrombolytic therapy (TT) and intra-aortic balloon counterpulsation (IABP) in experimental studies provides a rationale for their combined use in acute myocardial infarction (MI) complicated by cardiogenic shock. We examined the relation between TT (with and without IABP) and 12-month survival in the SHould We Emergently Revascularize Occluded Coronaries for Cardiogenic ShocK (SHOCK) Trial.

Methods and results

Among 302 patients with myocardial infarction and cardiogenic shock who were randomized in the SHOCK Trial, 16 had absolute contraindications to TT. Among 150 patients randomly assigned to initial medical stabilization (IMS), 63% received TT, as recommended per protocol, compared with 49% of 152 patients randomly assigned to emergency revascularization, in whom TT was not recommended if immediate angiography was available. IABP deployment, which was protocol-recommended, was used in 86% of patients. The rate of severe bleeding was similar in patients receiving TT and in those not receiving TT (31% vs 26%, P = .37). Among patients randomly assigned to IMS, TT was associated with improved 12-month survival (unadjusted mortality hazard ratio, 0.59; P = .01; mortality hazard ratio adjusted for age and prior MI, 0.62; P = .02). TT was not associated with improved 12-month survival among patients randomly assigned to emergency revascularization (unadjusted mortality hazard ratio, 0.93; P = .76; mortality hazard ratio adjusted for age and prior MI, 1.06, P = .81). The test for interaction of TT and randomization group P value was .16, and there was insufficient statistical power to demonstrate a differential effect of TT on 12-month survival by treatment group assignment.

Conclusions

Among patients randomly assigned to IMS in the SHOCK Trial, TT was associated with improved 12-month survival and did not significantly increase the risk of severe bleeding.