(Circulation. 2000;102:e53.)
© 2000 American Heart Association, Inc.
Cardiovascular News |
From St Lukes Episcopal Hospital/Texas Heart Institute, Houston, Tex.
Correspondence to James J. Ferguson, MD, Cardiology Research, MC 1191, St Lukes Episcopal Hospital/Texas Heart Institute, 6720 Bertner Ave, Houston, TX 77030. E-mail jferguson@heart.thi.tmc.edu
The following studies were presented at the 49th Scientific Sessions of the American College of Cardiology, March 1215, 2000, in Anaheim, Calif.
Acute Coronary Syndromes
The Trial: SYMPHONY II
Presenter: Kristin Newby, Duke University
Medical Center, Durham, NC.
The study: A randomized trial of sibrafiban (an oral glycoprotein [GP] IIb/IIIa antagonist) in patients with acute coronary syndromes. The study was originally designed to include 8400 patients, but it was terminated prematurely by the sponsor (unilaterally) after the negative results of SYMPHONY. At the time the trial was terminated, a total of 6671 patients had been enrolled. To qualify, patients had to present within 7 days with an acute coronary syndrome and be stabilized. They were then randomized to receive aspirin (80 mg every 12 hours), sibrafiban (high dose), or sibrafiban (low dose) plus aspirin (80 mg every 12 hours). The primary end point was the composite of death, myocardial infarction (MI), or severe recurrent ischemia. Secondary end points included the incidence of coronary ischemic events, reversible coronary ischemia, coronary revascularization, rehospitalization, stroke, and bleeding. Sibrafiban dosing was performed according to patient weight and renal function.
The results: No significant differences existed in the
primary composite end point of death, MI, or severe recurrent
ischemia in the 3 treatment arms (aspirin, 9.3%; low-dose
sibrafiban, 9.2%; high-dose sibrafiban, 10.5%). In the
high-dose sibrafiban arm, a statistically significant excess in the
composite of death and MI existed (8.6% versus 6.8% and 6.1% in the
low-dose sibrafiban and aspirin alone groups, respectively;
P<0.05 versus aspirin) and in death alone
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