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CLINICAL RESEARCH: COMBINED GLYCOPROTEIN IIB/IIIA INHIBITORS AND FIBRINOLYTICS

Outcome of acute ST-segment elevation myocardial infarction in diabetics treated with fibrinolytic or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition

Lessons from the GUSTO V trial

Hitinder S. Gurm, MD^*, A. Michael Lincoff, MD^*,*, David Lee, MD^*, W. H. Wilson Tang, MD^*, Gang Jia, MS^*, Joan E. Booth, RN^*, Robert M. Califf, MD, E. M. Ohman, MD, Frans Van de Werf, MD, PhD, Paul W. Armstrong, MD^||, Victor Guetta, MD^¶, Robert Wilcox, MD^# and Eric J. Topol, MD^*

^* Cleveland Clinic Foundation, Cleveland, Ohio, USA
Duke Clinical Research Institute, Durham, North Carolina, USA
The University of North Carolina at Chapel Hill, North Carolina, USA
University Hospital Gasthuisberg, Leuven, Belgium
^|| University of Alberta, Edmonton, Canada
^¶ The Chaim Sheba Medical Center, Tel-Hashomer, Israel
^# University Hospital Nottingham, Nottingham, United Kingdom

Manuscript received May 6, 2003; revised manuscript received July 29, 2003, accepted September 8, 2003.

^* Reprint requests and correspondence: Dr. A. Michael Lincoff, Department of Cardiovascular Medicine, Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, Ohio 44195, USA.
lincofa{at}ccf.org

OBJECTIVES: We studied the outcome of diabetics enrolled in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) V trial to assess whether the combination of half-dose reteplase and abciximab provides any propitious benefits over standard fibrinolytic therapy in diabetic patients.

BACKGROUND: Diabetics with acute ST-segment elevation myocardial infarction (MI) have a worse outcome compared with nondiabetics. Higher-risk patients are usually more likely to benefit from advances in medical therapy.

METHODS: We analyzed diabetic patients enrolled in the GUSTO V trial to assess the outcome of those randomized to the combination of half-dose reteplase and abciximab versus those randomized to reteplase. We also evaluated whether any differences existed in presentation and outcome of MI among the diabetics versus the nondiabetics enrolled in the study.

RESULTS: The trial enrolled 13,782 nondiabetics and 2,633 diabetics. Compared to nondiabetics, diabetics had a significantly higher mortality at 30 days (8.5% vs. 5.1%, p < 0.001) and at 1 year (12.7% vs. 7.5%, p < 0.001). Among the diabetic subset, no significant difference existed in the incidence of 30-day (8.8% vs. 8.2%, p = 0.52) or 1-year mortality (13.0% vs. 12.4%, p = 0.62) among patients randomized to reteplase compared to those receiving combination of abciximab and reteplase. The incidence of reinfarction (2.5% vs. 4.3%, p = 0.013), recurrent ischemia (11.8% vs. 14.9%, p = 0.017), and urgent revascularization (10.9% vs. 13.3%, p = 0.055) at seven days was lower in diabetics treated with the combination therapy.

CONCLUSIONS: Compared to nondiabetics, diabetics continue to have a worse outcome with MI. Although combination therapy did not provide a survival benefit, nonfatal ischemic outcomes, including reinfarction, recurrent ischemia, and urgent revascularization, were substantially reduced.

Abbreviations and Acronyms   ACE = angiotensin-converting enzyme   CI = confidence interval   ECG = electrocardiogram/electrocardiographic   GP = glycoprotein   GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries trial   IV = intravenous   MI = myocardial infarction   OR = odds ratio   PCI = percutaneous coronary intervention

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