STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial
Robert-Jan M van Geuns, Tuncay Yetgin, Alessio La Manna, Corrado Tamburino, Géraud Souteyrand, Pascal Motreff, Karel T Koch, Mathias Vrolix, Alexander IJsselmuiden, Giovanni Amoroso, Jacques Berland, Gilles Montalescot, Emmanuel Teiger, Evald H Christiansen, René Spaargaren, William Wijns, Robert-Jan M van Geuns, Tuncay Yetgin, Alessio La Manna, Corrado Tamburino, Géraud Souteyrand, Pascal Motreff, Karel T Koch, Mathias Vrolix, Alexander IJsselmuiden, Giovanni Amoroso, Jacques Berland, Gilles Montalescot, Emmanuel Teiger, Evald H Christiansen, René Spaargaren, William Wijns
Abstract
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.
Source: PubMed