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Previous Volume 359:2651-2662 December 18, 2008 Number 25 Next

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ABSTRACT

Background Approximately 70% of persons who have an out-of-hospital cardiac arrest have underlying acute myocardial infarction or pulmonary embolism. Therefore, thrombolysis during cardiopulmonary resuscitation may improve survival.

Methods In a double-blind, multicenter trial, we randomly assigned adult patients with witnessed out-of-hospital cardiac arrest to receive tenecteplase or placebo during cardiopulmonary resuscitation. Adjunctive heparin or aspirin was not used. The primary end point was 30-day survival; the secondary end points were hospital admission, return of spontaneous circulation, 24-hour survival, survival to hospital discharge, and neurologic outcome.

Results After blinded review of data from the first 443 patients, the data and safety monitoring board recommended discontinuation of enrollment of asystolic patients because of low survival, and the protocol was amended. Subsequently, the trial was terminated prematurely for futility after enrolling a total of 1050 patients. Tenecteplase was administered to 525 patients and placebo to 525 patients; the two treatment groups had similar clinical profiles. We did not detect any significant differences between tenecteplase and placebo in the primary end point of 30-day survival (14.7% vs. 17.0%; P=0.36; relative risk, 0.87; 95% confidence interval, 0.65 to 1.15) or in the secondary end points of hospital admission (53.5% vs. 55.0%, P=0.67), return of spontaneous circulation (55.0% vs. 54.6%, P=0.96), 24-hour survival (30.6% vs. 33.3%, P=0.39), survival to hospital discharge (15.1% vs. 17.5%, P=0.33), or neurologic outcome (P=0.69). There were more intracranial hemorrhages in the tenecteplase group.

Conclusions When tenecteplase was used without adjunctive antithrombotic therapy during advanced life support for out-of-hospital cardiac arrest, we did not detect an improvement in outcome, in comparison with placebo. (ClinicalTrials.gov number, NCT00157261 [ClinicalTrials.gov] .)

Source Information

From the University of Cologne, Cologne, and the University of Heidelberg, Heidelberg — both in Germany (B.W.B.); Charité, Benjamin Franklin Medical Center, Berlin (H.-R.A.); the Prehospital Emergency Research Unit, School of Medicine, Cardiff University, Cardiff, United Kingdom (D.A.C.); Boehringer Ingelheim, Biberach, Germany (E.B.); the Biostatistical Center, Catholic University of Leuven, Leuven, Belgium (A.B.); Boehringer Ingelheim, Reims, France (T.D.); Service d'Aide Médicale d'Urgence de Paris, Hôpital Necker–Enfants Malades, Paris (P.A.C.); the Regional Medical Cardiology Centre, Royal Victoria Hospital, Belfast, United Kingdom (J.A.A.); Albert-Ludwig-University, Freiburg, Germany (C.B.); and Innsbruck Medical University, Innsbruck, Austria (V.W.).

Address reprint requests to Dr. Böttiger at the Department of Anesthesiology and Postoperative Intensive Care Medicine, University of Cologne, Kerpener Str. 62, Cologne D-50937, Germany, or at bernd.boettiger{at}uk-koeln.de.

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This article has been cited by other articles:

• (2009). Thombolysis Fails to Improve Outcomes of Out-of-Hospital Cardiac Arrest. Journal Watch Cardiology 2009: 3-3 [Full Text]