Two-year Clinical Outcomes of Patients Treated with the Dual-therapy Stent in a 1000 Patient All-comers Registry

Overview

Journal Open Heart

Publisher BMJ Publishing Group

Specialty Cardiology & Vascular Diseases

Date 2017 Aug 2

PMID 28761685

Citations 2

Authors

Deborah N Kalkman

Pier Woudstra

Ian B A Menown

Peter den Heijer

Arnoud Wj Vant Hof

Andrejs Erglis

Harry Suryapranata

Karin E Arkenbout

Andres Iniguez

Philippe Muller

Jan G Tijssen

Marcel A M Beijk

Robbert J de Winter

Affiliations

Soon will be listed here.

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.

Citing Articles

Final five-year results of the REMEDEE Registry: Real-world experience with the dual-therapy COMBO stent.

Kerkmeijer L, Chandrasekhar J, Kalkman D, Woudstra P, Menown I, Suryapranata H Catheter Cardiovasc Interv. 2020; 98(3):503-510.

PMID: 33029937 PMC: 8518525. DOI: 10.1002/ccd.29305.

Development of a Bioactive Polymeric Drug Eluting Coronary Stent Coating Using Electrospraying.

McKittrick C, Cardona M, Black R, McCormick C Ann Biomed Eng. 2019; 48(1):271-281.

PMID: 31441008 PMC: 6928095. DOI: 10.1007/s10439-019-02346-6.

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