1. Long-term clinical and angiographic outcomes of diabetic patients after revascularization with early generation drug-eluting stents.
- Author
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Billinger M, Räber L, Hitz S, Stefanini GG, Pilgrim T, Stettler C, Zanchin T, Pulver C, Pfäffli N, Eberli F, Meier B, Kalesan B, Jüni P, and Windecker S
- Subjects
- Aged, Angioplasty, Balloon, Coronary methods, Coronary Angiography methods, Coronary Restenosis diagnostic imaging, Coronary Restenosis mortality, Coronary Restenosis therapy, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Diabetes Mellitus mortality, Diabetes Mellitus therapy, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Proportional Hazards Models, Prosthesis Design, Reference Values, Risk Assessment, Severity of Illness Index, Survival Analysis, Time, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary mortality, Coronary Stenosis therapy, Diabetes Mellitus diagnosis, Drug-Eluting Stents, Paclitaxel pharmacology, Sirolimus pharmacology
- Abstract
Background: Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established., Methods: A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients., Results: Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79)., Conclusions: Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES., (Copyright © 2012 Mosby, Inc. All rights reserved.)
- Published
- 2012
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