Randomized, Double-Blind Study Comparing Saruplase with Streptokinase Therapy in Acute Myocardial Infarction: the COMPASS Equivalence Trial
JACC Vol. 31, No. 3 487 March 1, 1998:487–93 CLINICAL STUDIES MYOCARDIAL INFARCTION Randomized, Double-Blind Study Comparing Saruplase With Streptokinase Therapy in Acute Myocardial Infarction: The COMPASS Equivalence Trial ULRICH TEBBE, MD, ROLF MICHELS, MD,* JENNIFER ADGEY, MD, FRCP,† JEAN BOLAND, MD,‡ AVI CASPI, MD,§ BERNARD CHARBONNIER, MD,\ JU¨ RGEN WINDELER, MD,¶ HANNES BARTH, MD,# ROBERT GROVES, PHD,# GWYN R. HOPKINS, BSC, MRCP, MFPM,# WILLIAM FENNELL, MD, FRCPI,** AMADEO BETRIU, MD,†† MIKHAIL RUDA, MD,‡‡ JOHANNES MLCZOCH, MD,§§ FOR THE COMPARISON TRIAL OF SARUPLASE AND STREPTOKINASE (COMASS) INVESTIGATORS\\ Lippe-Detmold, Bochum and Aachen, Germany; Eindhoven, The Netherlands; Belfast, Northern Ireland, United Kingdom; Lie`ge, Belgium; Rehovot, Israel; Tours, France; Cork, Ireland; Barcelona, Spain; Moscow, Russian Federation; and Vienna, Austria Objectives. This study sought to demonstrate the equivalence of Results. Death of any cause up to 30 days after randomization saruplase and streptokinase in terms of 30-day mortality. occurred in 88 (5.7%) of 1,542 patients randomized to receive Background. The use of thrombolytic agents in the treatment of saruplase and 104 (6.7%) of 1,547 patients randomized to receive acute myocardial infarction is well established and has been streptokinase (odds ratio 0.84, p < 0.01 for equivalence). Hemor- shown to substantially reduce post-myocardial infarction mortal- rhagic strokes occurred more often in patients receiving saruplase ity. (0.9% vs. 0.3%), whereas thromboembolic strokes were more Methods. Three thousand eighty-nine patients with symptoms prevalent in the streptokinase-treated patients (0.5% vs. 1.0%). compatible with those of acute myocardial infarction for <6 h The rate of bleeding was similar in the two treatment groups entered the study at a total of 104 centers and were randomized to (10.4% vs.
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