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Interventional cardiology
Original research article
Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction
  1. Wouter S Remkes1,
  2. Erik A Badings2,
  3. Renicus S Hermanides1,
  4. Saman Rasoul3,
  5. Jan-Henk E Dambrink1,
  6. Petra C Koopmans1,
  7. Salem HK The4,
  8. Jan Paul Ottervanger1,
  9. A T Marcel Gosselink1,
  10. Jan CA Hoorntje3,
  11. Harry Suryapranata1,5 and
  12. Arnoud WJ van 't Hof1
  1. 1Isala heart centre, Zwolle, The Netherlands
  2. 2Deventer Ziekenhuis, Deventer, The Netherlands
  3. 3Maastricht University Medical Center, Maastricht, The Netherlands
  4. 4Ziekenhuis Bethesda, Hoogeveen, The Netherlands
  5. 5Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
  1. Correspondence to Dr Arnoud WJ van 't Hof; v.r.c.derks{at}isala.nl

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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/openhrt-2016-000455

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    Footnotes

    • Contributors WSR and AWJvH participated in design and concept of the current study and the Zwolle studies, data handling and preparation of the manuscript. JCAH and HS were involved in design and set-up of the Zwolle studies, critical comments and revision of the manuscript. PCK undertook statistical analysis. EAB, JPO, ATMG, SHKT, SR, RSH and J-HED critically revised the manuscript.

    • Funding Abbott (unrestricted research grant). The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report.

    • 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.

    • Ethics approval The ethics committee of Isala, Zwolle.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.

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