Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction. Issue 2 (17th November 2016)

• Record Type: Journal Article
• Authors: Remkes, Wouter S; Badings, Erik A; Hermanides, Renicus S; Rasoul, Saman; Dambrink, Jan-Henk E; Koopmans, Petra C; The, Salem HK; Ottervanger, Jan Paul; Gosselink, A T Marcel; Hoorntje, Jan CA; Suryapranata, Harry; van 't Hof, Arnoud WJ
• Is Part Of: Open heart. Volume 3:Issue 2(2016)
• Publication Date: 2016-11-17
• Subjects: Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; Heart -- Diseases -- Patients -- Periodicals; 616.12005
• DOI: 10.1136/openhrt-2016-000455
• Languages: English
• ISSNs: 2398-595X

Abstract

Abstract : Objective: The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. Methods: ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. Results: 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. Conclusions: In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163 . Trial registration number: 39230163 ; Post-results.