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Aims: Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some 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 and effectiveness of the SYNERGY stent in patients with diabetes mellitus. Methods and Results: SYNERGY is a thin-strut, platinum-chromium everolimus-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-TLR], 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-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF 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 TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. Conclusion(s): The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes. Clinical Trial Registration Information: NCT01665053 (http://clinicaltrials.gov/).Copyright © Europa Digital & Publishing 2017. All rights reserved.

Aims: Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some 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 and effectiveness of the SYNERGY stent in patients with diabetes mellitus. Methods and Results: SYNERGY is a thin-strut, platinum-chromium everolimus-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-TLR], 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-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF 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 TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. Conclusion(s): The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes. Clinical Trial Registration Information: NCT01665053 (http://clinicaltrials.gov/).Copyright © Europa Digital & Publishing 2017. All rights reserved.

Aims: Bioabsorbable-polymer DES may reduce inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with diabetes mellitus, is unknown. Methods and Results: We report the prespecified analysis of patients with medically-treated diabetes enrolled in the EVOLVE II trial at 2 years following SYNERGY stent deployment. SYNERGY is a novel, thin-strut, platinum chromium stent eluting everolimus from an ultrathin 4mum bioabsorbable poly(DL-lactide-co-glycolide) polymer applied to the abluminal side of the stent. The polymer resorbs shortly after everolimus elution is complete at 3 months. SYNERGY was found to be noninferior to the permanent polymer coated PROMUS Element Plus stent for the primary endpoint of 12-month target lesion failure (TLF: composite occurrence of ischaemia-driven target lesion revascularisation, target-vessel myocardial infarction, or cardiac death) in the EVOLVE II pivotal, randomised controlled trial (RCT). The EVOLVE II Diabetes substudy pooled: 1) patients with diabetes randomised to the SYNERGY arm of the EVOLVE II RCT (N=263) and, 2) patients with diabetes enrolled in the non-randomised Diabetes single-arm study (N=203) following EVOLVE II RCT completion for a total of 466 patients with diabetes treated with SYNERGY stent. Enrolled patients could have up to 3 native coronary artery lesions in up to 2 major epicardial vessels with reference vessel diameter >=2.25 mm to <=4.00 mm, and lesion length <=34 mm. Exclusion criteria included recent (<72 hours) STEMI, left main, vein graft or ostial stenosis, in stent restenosis, chronic total occlusion, or thrombus. The prespecified Diabetes substudy primary endpoint was 12-month TLF tested against a prespecified performance goal based on TLF rates derived from cohorts of patients with diabetes treated with permanent polymer everolimus-eluting stents in prior studies (PLATINUM, SPIRIT IV, COMPARE, EVOLVE).

Aims: Bioabsorbable-polymer DES may reduce inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with diabetes mellitus, is unknown. Methods and Results: We report the prespecified analysis of patients with medically-treated diabetes enrolled in the EVOLVE II trial at 2 years following SYNERGY stent deployment. SYNERGY is a novel, thin-strut, platinum chromium stent eluting everolimus from an ultrathin 4mum bioabsorbable poly(DL-lactide-co-glycolide) polymer applied to the abluminal side of the stent. The polymer resorbs shortly after everolimus elution is complete at 3 months. SYNERGY was found to be noninferior to the permanent polymer coated PROMUS Element Plus stent for the primary endpoint of 12-month target lesion failure (TLF: composite occurrence of ischaemia-driven target lesion revascularisation, target-vessel myocardial infarction, or cardiac death) in the EVOLVE II pivotal, randomised controlled trial (RCT). The EVOLVE II Diabetes substudy pooled: 1) patients with diabetes randomised to the SYNERGY arm of the EVOLVE II RCT (N=263) and, 2) patients with diabetes enrolled in the non-randomised Diabetes single-arm study (N=203) following EVOLVE II RCT completion for a total of 466 patients with diabetes treated with SYNERGY stent. Enrolled patients could have up to 3 native coronary artery lesions in up to 2 major epicardial vessels with reference vessel diameter >=2.25 mm to <=4.00 mm, and lesion length <=34 mm. Exclusion criteria included recent (<72 hours) STEMI, left main, vein graft or ostial stenosis, in stent restenosis, chronic total occlusion, or thrombus. The prespecified Diabetes substudy primary endpoint was 12-month TLF tested against a prespecified performance goal based on TLF rates derived from cohorts of patients with diabetes treated with permanent polymer everolimus-eluting stents in prior studies (PLATINUM, SPIRIT IV, COMPARE, EVOLVE).