1. Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial
- Author
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Harada, Yukinori, Colleran, Roisin, Kufner, Sebastian, Giacoppo, Daniele, Rheude, Tobias, Michel, Jonathan, Cassese, Salvatore, Ibrahim, Tareq, Laugwitz, Karl-Ludwig, Kastrati, Adnan, and Byrne, Robert A.
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Male ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Myocardial Infarction ,Kaplan-Meier Estimate ,Coronary Angiography ,Prosthesis Design ,Disease-Free Survival ,Coronary Restenosis ,Percutaneous Coronary Intervention ,Risk Factors ,Drug-Eluting Stent ,Humans ,cardiovascular diseases ,Original Investigation ,Aged ,Proportional Hazards Models ,Sirolimus ,Coronary Thrombosis ,Diabetes ,Cardiovascular Agents ,Drug-Eluting Stents ,Middle Aged ,equipment and supplies ,Probucol ,Treatment Outcome ,surgical procedures, operative ,Cardiovascular Diseases ,Retreatment ,Female ,Zotarolimus ,Cardiology and Cardiovascular Medicine ,Diabetic Angiopathies ,Platelet Aggregation Inhibitors - Abstract
Background Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial. Methods In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan–Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models. Results A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76–1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63–1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40–1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72–1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41–2.52). Conclusions In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008
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