Paclitaxel versus sirolimus eluting stents in diabetic patients: does stent type and/or stent diameter matter? Long-term clinical outcome of 2429-patient multicenter registry.

BACKGROUND:Drug-eluting stents (DES) are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of the 2 widely used DES- sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)-in diabetic patients undergoing percutaneous coronary intervention (PCI). OBJECTIVES: We studied the long-term effectiveness and safety of SES versus PES in diabetic patients, overall and grouped by the size of the stent placed in the native stented vessel. METHODS: Data were obtained from an observational, multicenter registry of 2,429 consecutive patients with DM who underwent PCI between August 2003 and August 2009 with SES (n=1370) or PES (n=1059). Data were analyzed separately for patients with small stents (<3.0 mm, n= 1274) vs only large (≥3.0 mm, n=1155). RESULTS: At Cox adjusted analysis of the overall cohort, there was no significant difference between SES and PES with regard to death/myocardial infarction (D/MI) (p=0.6) or target lesion revascularization (TLR) (p=0.3) either in 'small-stent' (D/MI, p=0.8; TLR, p=0.2) or 'large stent' group (D/MI, p=0.8; TLR, p=0.4) throughout 1 to 5-year follow-up. These results were confirmed by sensitivity, propensity-score matched analysis (717 matched pairs) that failed to find differences in the safety and efficacy between SES and PES. CONCLUSIONS: In this large observational study, PES and SES were equally safe and efficacious in diabetic patients undergoing PCI in clinical practice, regardless of the stent size.