RT Journal Article
SR Electronic
T1 Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e000634
DO 10.1136/openhrt-2017-000634
VO 4
IS 2
A1 Deborah N Kalkman
A1 Pier Woudstra
A1 Ian B A Menown
A1 Peter den Heijer
A1 Arnoud WJ van't Hof
A1 Andrejs Erglis
A1 Harry Suryapranata
A1 Karin E Arkenbout
A1 Andrés Iñiguez
A1 Philippe Muller
A1 Jan G Tijssen
A1 Marcel A M Beijk
A1 Robbert J de Winter
YR 2017
UL http://openheart.bmj.com/content/4/2/e000634.abstract
AB 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.