Sirolimus-eluting vs. paclitaxel-eluting stents in diabetic and non-diabetic patients with in "LIMUS"-stent restennosis, results from the ISAR DESIRE 2 trial

Abstract

Background: Concern exists relating to potential attenuated efficacy of limus-eluting stents in patients with diabetes mellitus. In this respect diabetic patients with sirolimus-eluting stent (SES) failure requiring reintervention may be expected to derive particular benefit from a treatment-switch to paclitaxel-eluting stent (PES) implantation. Objective: The aim of the current report was to investigate outcomes of patients with SES restenosis randomized to treatment with repeat SES implantation (same stent strategy) or PES (switch stent strategy) according to the presence or absence of diabetes mellitus. Methods: In the setting of ISAR-DESIRE 2 trial patients with clinically significant SES restenosis were randomly assigned to receive either SES or PES. The primary end point was in-stent late lumen loss at 6-8 month follow-up angiography. Secondary endpoints were binary angiographic restenosis (diameter stenosis >50%) and target lesion revascularization (TLR), the composite of death or myocardial infarction (MI) and definite stent thrombosis at 12 months. Results: Of 450 patients enrolled, 162 (36.0%) had a diagnosis of diabetes mellitus. Late loss was comparable between SES and PES both in patients with diabetes (0.38±0.59mm vs. 0.37±0.59mm; p=0.97) and without (0.41±0.67mm vs. 0.38±0.6mm; p=0.98). Similarly binary restenosis was comparable between SES and PES in patients with diabetes (19.0% vs. 26.0%; p=0.32) or without (18.9% vs. 17.8%; p=0.98). TLR, death or MI and definite stent thrombosis were also similar in SES versus PES treatment groups regardless of diabetes status. ![Figure][1] Primary endpoint Conclusions: In cases of SES-restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy and safety, regardless of diabetic status. [1]: pending:yes