Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry

Deborah N Kalkman, Pier Woudstra, Ian B A Menown, Peter den Heijer, Arnoud Wj Van't Hof, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Philippe Muller, Jan G Tijssen, Marcel A M Beijk, Robbert J de Winter, Deborah N Kalkman, Pier Woudstra, Ian B A Menown, Peter den Heijer, Arnoud Wj Van't Hof, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Philippe Muller, Jan G Tijssen, Marcel A M Beijk, Robbert J de Winter

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.

Keywords: Coronary Artery Disease; Coronary Intervention (pci); Coronary Stenting; Interventional Cardiology.

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
The COMBO stent design, illustration of the dual-therapy stent technology.
Figure 2
Figure 2
Cumulative event rate of target lesion failure by Kaplan-Meier method.
Figure 3
Figure 3
Cardiac death, target vessel myocardial infarction (MI), target lesion revascularisation (TLR) by Kaplan-Meier method. (A) Cumulative event rate of the individual endpoint cardiac death. (B) Cumulative event rate of the individual endpoint target vessel-related MI. (c) Cumulative event rate of the individual endpoint TLR.
Figure 4
Figure 4
Subgroups. HR of gender, age, diabetic status, smoking (current and previous), hypertension, hypercholesterolaemia, chronic renal failure, previous stroke, peripheral vascular disease and acute coronary syndrome (ACS) on target lesion failure at 2-year follow-up. PCI, percutaneous coronary intervention
Figure 5
Figure 5
Comparison of target vessel failure at 2-year follow-up with other drug eluting stents (DES). DTS, dual-therapy stent; EES, everolimus-eluting stent; PES, paclitaxel-eluting stent; ZES, zotarolimus-eluting stent.

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