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(Circulation. 2002;105:2730.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Division of Cardiology, University Hospital, Zurich, Switzerland (M.R.); the Department of Cardiovascular Medicine and C5 (Cleveland Clinic Cardiovascular Coordinating Center), The Cleveland Clinic Foundation, Cleveland, Ohio (D.J.M., E.J.T.); Swiss Cardiovascular Center, Bern, Switzerland (B.M.); the University of Virginia School of Medicine, Charlottesville (E.R.P.); William Beaumont Hospital, Royal Oak, Mich (C.L.G.); Merck, West Point, Pa (P.M.D., K.E.H., L.A.D.); University of Pennsylvania Medical Center, Philadelphia (H.C.H.); and University of Lille, Lille, France (M.B.).
Correspondence to David J. Moliterno, MD, Department of Cardiovascular Medicine, F-25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195. E-mail molited{at}ccf.org
Background The platelet glycoprotein IIb/IIIa receptor inhibitor abciximab, a monoclonal antibody, has been shown to improve early and late outcomes among diabetic patients undergoing percutaneous coronary intervention (PCI). It is unknown whether small-molecule agents confer similar benefits.
Methods and Results In 18 countries, 4809 patients undergoing PCI with stent implantation were randomized to tirofiban or abciximab. At the time of enrollment, patients were stratified according to diabetes status. As compared with non-diabetic patients, patients with diabetes (n=1117) showed similar 30-day ischemic outcomes, an increased incidence of any target vessel revascularization (TVR) at 6 months (10.3% versus 7.8%; P= 0.008), and a trend toward higher 1-year mortality (2.5% versus 1.6%; P=0.056). Among diabetic patients randomized to tirofiban (n=560), the incidence of death, myocardial infarction (MI), or urgent TVR at 30 days was 6.2%, and among those randomized to abciximab (n=557) it was 5.4% (hazard ratio [HR] 1.16; P=0.540). At 6 months, the composite of death, MI, or any TVR occurred in 15.7% and in 16.9% of tirofiban and abciximab patients, respectively (HR 0.93; P=0.610). Any TVR occurred in 9.5% and 11.1%, respectively (HR 0.84; P= 0.366). The 1-year mortality was 2.1% in the tirofiban group and 2.9% in the abciximab group (HR 0.74; P= 0.436).
Conclusions Among diabetic patients undergoing PCI, tirofiban and abciximab were associated with comparable event rates, including similar rates of 6-month TVR and 1-year mortality. These findings suggest that the non-glycoprotein IIb/IIIa properties of abciximab do not translate into a discernible long-term clinical benefit among diabetic patients.
Key Words: glycoproteins stents diabetes mellitus platelets
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