Abstract 10234: A Randomized Comparison of Sirolimus- versus Paclitaxel-Eluting Stent Implantation in Patients with Diabetes Mellitus: 4-Year Clinical Outcomes of DES-DIABETES Trial
Objectives: We compared 4-year efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with diabetes mellitus (DM).
Background: Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.
Methods: This prospective, multicenter, randomized study compared SES (n=200) and PES (n=200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).
Results: The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, HR: 0.30, 95% CI, 0.13 to 0.71, p=0.006) and MACE (3.5% vs. 12.5%, HR: 0.27, 95% CI, 0.11 to 0.61, p=0.002) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p=0.445) or MI (1.5% vs. 1.0%, p=0.999) between SES and PES group. TLR (7.5% vs. 12.0%, HR: 0.54, 95% CI, 0.28 to 1.05, p=0.069) and MACE (11.0% vs. 16.0%, HR: 0.61, 95% CI, 0.35 to 1.05, p=0.076) were statistically not different between SES and PES group. At multivariate Cox regression, postprocedural minimal lumen diameter (MLD) were independent predictor of 4-year TLR (HR: 0.24, 95% CI, 0.10 to 0.55, p=0.0008) and MACE (HR: 0.38, 95% CI, 0.20 to 0.71, p=0.0027).
Conclusions: Superiority of SES over PES during 2 years was attenuated between 2 year and 4 years in diabetic patients. Larger postprocedural MLD was independent predictor of the improved long-term clinical outcomes.
- © 2010 by American Heart Association, Inc.