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

: Kereiakes DJ, Meredith IT, Masotti M, Carrie D, Moreno R, Erglis A, Mehta SR, Elhadad S, Berland J, Stein B, Airaksinen J, Jobe RL, Reitman A, Janssens L, Christen T, Dawkins KD, Windeeker S, Windeeker S

Publisher: EUROPA EDITION

: 2017

: Eurointervention

: EUROINTERVENTION

: 12

: 16

: 1987

: 1994

: 8

: 1774-024X

: 1969-6213

DOI: https://doi.org/10.4244/EIJ-D-16-00643

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/)