A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: The DECODE study^†

Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions. Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few. Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months. Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006). Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS. © 2008 Wiley-Liss, Inc.