STENTYS self-apposing® sirolimus-eluting STENT in ST-segment elevation myocardial infarction: Results from the randomised apposition IV trial
EuroIntervention , Volume 11 - Issue 11 p. e1267- e1274
Aims: We sought to investigate the impact of the self-apposing, sirolimus-eluting STENTYS stent on midterm and long-term stent apposition and strut coverage compared with a zotarolimus-eluting balloon-expandable stent in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI).
Methods and results: In the APPOSITION IV trial, 152 STEMI patients were randomised (3:2) to the self-apposing, sirolimus-eluting STENTYS stent or a commercially available zotarolimus-eluting balloon-expandable stent at 12 sites in five countries with angiographic follow-up and optical coherence tomography at four or nine months. At four months, a lower percentage of malapposed stent struts was observed in the STENTYS group (N=21; Nstruts=501) compared with controls (N=26; Nstruts=326; 0.07% vs. 1.16%; p=0.002) with significantly more covered struts, using a 20 µm cut-off (94.32% vs. 89.09%; p=0.003). At nine months, the primary endpoint (percentage malapposed stent struts) was similar in both groups (STENTYS, N=40; Nstruts=566; control, N=21; Nstruts=292), showing complete apposition (p=0.55) and near total (>96%) coverage (p=0.58).
Conclusions: In STEMI patients undergoing PPCI, the self-apposing, sirolimus-eluting STENTYS stent was equivalent to a conventional drug-eluting balloon-expandable stent with respect to late stent strut apposition and coverage at nine months. However, stent strut apposition and coverage at four months were significantly better in the STENTYS group.
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van Geuns, R.J.M, Yetgin, T, La Manna, A, Tamburino, C, Souteyrand, G, Motreff, P, … Wijns, W. (2016). STENTYS self-apposing® sirolimus-eluting STENT in ST-segment elevation myocardial infarction: Results from the randomised apposition IV trial. EuroIntervention, 11(11), e1267–e1274. doi:10.4244/EIJV11I11A248