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Interventional cardiology
Original research article
Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
  1. Deborah N Kalkman1,
  2. Pier Woudstra1,
  3. Ian B A Menown2,
  4. Peter den Heijer3,
  5. Arnoud WJ van't Hof4,
  6. Andrejs Erglis5,
  7. Harry Suryapranata6,
  8. Karin E Arkenbout7,
  9. Andrés Iñiguez8,
  10. Philippe Muller9,
  11. Jan G Tijssen1,
  12. Marcel A M Beijk1 and
  13. Robbert J de Winter1
  1. 1 Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  2. 2 Craigavon Cardiac Centre, Craigavon, UK
  3. 3 Amphia Hospital Breda, Breda, The Netherlands
  4. 4 Isala Klinieken, Zwolle, The Netherlands
  5. 5 Pauls Stradins Clinical University Hospital, Riga, Latvia
  6. 6 Radboud University Medical Center, Nijmegen, The Netherlands
  7. 7 Tergooi Ziekenhuis, Blaricum, The Netherlands
  8. 8 Hospital Álvaro Cunqueiro - Complejo Hospitalario Universitario, Vigo, Spain
  9. 9 Institut National de Cardiochirurgie et de Cardiologie Interventionnelle, Luxembourg
  1. Correspondence to Dr Deborah N Kalkman; d.n.kalkman{at}amc.uva.nl

Abstract

Objective The dual-therapy stent combines an abluminal biodegradable drug-eluting coating, with a ‘pro-healing’ luminal layer. This bioengineered layer attracts circulating endothelial progenitor cells that can differentiate into normal endothelium. Rapid endothelialisation of the stent might allow safe short dual antiplatelet therapy. We aim to assess clinical outcomes in patients treated with this novel device at 2-year follow-up.

Methods A total of 1000 patients were included in the REMEDEE Registry to evaluate clinical outcomes after treatment with the dual-therapy stent. This prospective, multicentre, European registry included all-comers patients, which resulted in a high-risk patient population. Target lesion failure (TLF), a combined endpoint consisting of cardiac death, target vessel myocardial infarction (tv-MI) and target lesion revascularisation (TLR), at 2-year follow-up was the primary focus of this analysis. Subgroup analyses were performed according to diabetes mellitus (DM), gender, age, acute coronary syndrome, smoking, hypertension, hypercholesterolaemia, previous stroke, peripheral vascular disease and chronic renal failure.

Results TLF at 2 years was observed in 84 patients (8.5%), with 3.0% cardiac death, 1.2% tv-MI and 5.9% TLR. Definite stent thrombosis at 2 years was 0.6%. In the presence of DM or chronic renal failure, a higher TLF was observed.

Conclusions The dual-therapy stent shows favourable clinical outcomes from 12 months onwards. Two years after stent placement, low TLF and very low stent thrombosis rates are observed in this large prospective all-comers cohort study.

Trial registration number NCT01874002; Results.

  • Coronary Artery Disease
  • Interventional Cardiology
  • Coronary Intervention (pci)
  • Coronary Stenting

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-2017-000634

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    Footnotes

    • Contributors DNK and PW contributed to the conception, design, analysis and interpretation of data and drafting of the manuscript and final approval of the manuscript submitted. IBAM, PdH, AWJvH, AE, HS, KEA, AI, PM, and MAMB contributed to the conception and design of data and revising manuscript critically for important intellectual content and final approval of the manuscript submitted. JGT and RJdW contributed to the conception, design, analysis and interpretation of data and drafting of the manuscript and revising manuscript critically for important intellectual content and final approval of the manuscript submitted.

    • Funding The Academic Medical Center, University of Amsterdam received an unrestricted research grant from OrbusNeich Medical B.V., the Netherlands.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval A waiver was obtained from the ethics committee of the Academic Medical Center, University of Amsterdam.

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

    • Data sharing statement The relevant anonymised patient-level data are available on reasonable request to the corresponding author.