Dual Therapy Stents
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.
Preclinical research showed early endothelialisation with this dual-therapy stent technology. One-year clinical results of the 1000 patient registry have been reported with low event rates.
There is a need for long-term clinical follow-up of novel coronary devices. This large prospective, investigator-initiated, all-comers cohort evaluates the real-world clinical performance of this dual-therapy COMBO stent at 2 years after stent placement. Low event rates are observed at 2-year follow-up.
The dual-therapy stent shows good 2-year clinical results and might be the preferred treatment strategy in patients with coronary artery disease, and especially in patients with indication for short dual-antiplatelet therapy. Randomised trials are needed to support this hypothesis.