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
Full text not available from this repository. (Request a copy)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: |
05 Dec 2022 14:59 |
Publisher DOI: |
10.4244/EIJ-D-16-00643 |
PubMed ID: |
27840326 |
URI: |
https://boris.unibe.ch/id/eprint/90369 |
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