Sirolimus-eluting versus paclitaxel-eluting stents in diabetic and non-diabetic patients within sirolimus-eluting stent restenosis: Results from the ISAR-DESIRE 2 trial

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 SES (same stent strategy) or PES (switch stent strategy) in the pre-specified subgroups of patients with and without diabetes mellitus. Methods: In the setting of ISAR-DESIRE 2 trial, 450 patients with clinically significant SES restenosis were randomly assigned to receive either SES or PES. The primary end point was in-stent late 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. In patients with diabetes 86 patients were randomly assigned to SES versus 76 to PES. In patients without diabetes 139 were assigned to SES versus 149 to PES. 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; p_interaction=0.89). 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; p_interaction=0.36). TLR, death or MI and definite stent thrombosis were also similar in SES versus PES treatment groups regardless of diabetes status. Conclusions: In cases of SES-restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy, regardless of diabetic status.