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Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction.
- Source :
-
Open heart [Open Heart] 2016 Nov 17; Vol. 3 (2), pp. e000455. Date of Electronic Publication: 2016 Nov 17 (Print Publication: 2016). - Publication Year :
- 2016
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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.<br />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.<br />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.<br />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.<br />Trial Registration Number: 39230163; Post-results.<br />Competing Interests: EAB received consulting fees from Merck Sharp and Dohme and Sanofi-Aventis. AWJv H received speaker’s fees and research grants from Merck, Sanofi-Aventis, The Medicines Company, Iroko Cardio and AstraZeneca.
Details
- Language :
- English
- ISSN :
- 2053-3624
- Volume :
- 3
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Open heart
- Publication Type :
- Academic Journal
- Accession number :
- 27933192
- Full Text :
- https://doi.org/10.1136/openhrt-2016-000455