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Results From the Primary Coronary Angioplasty vs Thrombolysis–2 Trial

Jorik R. Timmer, MD, PhD; Jan Paul Ottervanger, MD, PhD; Menko-Jan de Boer, MD, PhD; Eric Boersma, PhD; Cindy L. Grines, MD; Cynthia M. Westerhout, MD; R. John Simes, MD, FRACP; Christopher B. Granger, MD; Felix Zijlstra, MD, PhD; for the Primary Coronary Angioplasty vs Thrombolysis–2 Trialists Collaborators Group

Arch Intern Med. 2007;167(13):1353-1359.

Background  There is growing evidence for a clinical benefit of primary percutaneous coronary intervention (PCI) compared with fibrinolysis; however, whether the treatment effect is consistent among patients with diabetes mellitus is unclear. We compared PCI with fibrinolysis for treatment of ST-segment elevation myocardial infarction in patients with diabetes mellitus.

Methods  A pooled analysis of individual patient data from 19 trials comparing primary PCI with fibrinolysis for treatment of ST-segment elevation myocardial infarction was performed. Trials that enrolled at least 50 patients with ST-segment elevation myocardial infarction and randomized patients to receive either primary PCI or fibrinolysis were considered for inclusion in our study. Clinical end points were total deaths, recurrent infarction, death or nonfatal recurrent infarction, and stroke, measured 30 days after randomization.

Results  Of 6315 patients, 877 (14%) had diabetes. Thirty-day mortality (9.4% vs 5.9%; P < .001) was higher in patients with diabetes. Mortality was lower after primary PCI compared with fibrinolysis in both patients with diabetes (unadjusted odds ratio, 0.49; 95% confidence interval, 0.31-0.79; P = .004) and without diabetes (unadjusted odds ratio, 0.69; 95% confidence interval, 0.54-0.86, P = .001), with no evidence of heterogeneity of treatment effect (P = .24 for interaction). Recurrent infarction and stroke were also reduced after primary PCI in both patient groups. After multivariable analysis, primary PCI was associated with decreased 30-day mortality in patients with and without diabetes, with a point estimate of greater benefit in diabetic patients.

Conclusions  Diabetic patients with ST-segment elevation myocardial infarction treated with reperfusion therapy have increased mortality compared with patients without diabetes. The beneficial effects of primary PCI compared with fibrinolysis in diabetic patients are consistent with effects in nondiabetic patients.

Author Affiliations: Department of Cardiology, Isala Klinieken, Zwolle, the Netherlands (Drs Timmer, Ottervanger, and de Boer); Clinical Epidemiology Unit, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (Drs Boersma and Westerhout); William Beaumont Hospital, Royal Oak, Michigan (Dr Grines); Department of Medicine, University of Alberta, Edmonton (Dr Westerhout); National Health and Medical Research Counsel Clinical Trials Centre, University of Sydney, Sydney, Australia (Dr Simes); Duke Clinical Research Institute, Durham, North Carolina (Dr Granger); and Department of Cardiology, Thoraxcenter, University Medical Center Groningen, Groningen, the Netherlands (Dr Zijlstra).

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