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. 2016 Nov 17;3(2):e000455.
doi: 10.1136/openhrt-2016-000455. eCollection 2016.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

Wouter S Remkes  1 , Erik A Badings  2 , Renicus S Hermanides  1 , Saman Rasoul  3 , Jan-Henk E Dambrink  1 , Petra C Koopmans  1 , Salem Hk The  4 , Jan Paul Ottervanger  1 , A T Marcel Gosselink  1 , Jan Ca Hoorntje  3 , Harry Suryapranata  5 , Arnoud Wj van 't Hof  1
Affiliations

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

Wouter S Remkes et al. Open Heart. .

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow diagram of study design. BMS, bare-metal stent; EES, everolimus-eluting stent; MACE, major adverse cardiac events (composite of death, myocardial infarction and target vessel revascularisation); PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Kaplan-Meier curves showing freedom from MACE up to 720 days after the index procedure in the pooled population. MACE, major adverse cardiac events (composite of death, myocardial infarction and target vessel revascularisation).
Figure 3
Figure 3
Kaplan-Meier curves showing freedom from stent thrombosis up to 720 days after the index procedure in the pooled population.
See this image and copyright information in PMC

Comment in

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