Paclitaxel versus sirolimus eluting stents in diabetic patients: does stent type and/or stent diameter matter?: long-term clinical outcome of 2,429-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 two 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 = 1,370) or PES (n = 1,059). Data were analyzed separately for patients with small stents (<3.0 mm, n = 1,274) vs. only large (≥3.0 mm, n = 1,155).

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.