Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy

Aims: Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflanunation and delayed healing associated with sonic permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety mid effectiveness of the SYNERGY stent in patients with diabetes mellitus. Methods and results: SYNERGY is a thin-stnit, platinum -chromium everol mus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TERI, target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-ann diabetic cohort (n=203). The substudy primary endpoint was one-year TEE compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TEE was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TER 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. Conclusions: The EVOLVE II diabetes substudy demonstrates the efficacy mid safety of the SYNERGY stein in patients with medically treated diabetes. Clinical Trial Registration Tnthnnation: NCT01665053 (http://clinicaltrials.gov/)