Safety and Efficacy of a Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent in Patients with Diabetes: the EVOLVE II Diabetes Substudy.

Kereiakes, Dean J; Meredith, Ian T; Masotti, Monica; Carrié, Didier; Moreno, Raul; Erglis, Andrejs; Mehta, Shamir R; Elhadad, Simon; Berland, Jacques; Stein, Bernardo; Airaksinen, Juhani; Jobe, R Lee; Reitman, Arthur; Janssens, Luc; Christen, Thomas; Dawkins, Keith D; Windecker, Stephan (2017). Safety and Efficacy of a Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent in Patients with Diabetes: the EVOLVE II Diabetes Substudy. EuroIntervention, 12(16), pp. 1987-1994. Europa Digital & Publishing 10.4244/EIJ-D-16-00643

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AIMS Bioabsorbable-polymer drug-eluting stents (DES) may reduce 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. METHODS AND RESULTS SYNERGY is a thin-strut, platinum chromium everolimus-eluting stent with an ultrathin bioabsorbable poly (DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomized, controlled trial proved noninferiority of SYNERGY versus the PROMUS Element Plus stent for 1-year target lesion failure (TLF: ischemia- driven target lesion revascularization [ID-TLR], target-vessel myocardial infarction [TVMI], or cardiac death). The prespecified EVOLVE II Diabetes Substudy prospectively pooled randomized patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was 1-year TLF compared with a prespecified 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 2-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. CONCLUSIONS The EVOLVE II Diabetes substudy demonstrates efficacy and safety of the SYNERGY stent in patients with medically-treated diabetes.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1774-024X

Publisher:

Europa Digital & Publishing

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

12 Jul 2018 13:34

Last Modified:

12 Jul 2018 13:34

Publisher DOI:

10.4244/EIJ-D-16-00643

PubMed ID:

27840326

URI:

https://boris.unibe.ch/id/eprint/90369

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