STENTYS Self-Apposing® sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial.
|Title||STENTYS Self-Apposing® sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial.|
|Publication Type||Journal Article|
|Year of Publication||2016|
|Authors||van Geuns, R. - J. M., T. Yetgin, A. La Manna, C. Tamburino, G. Souteyrand, P. Motreff, K. T. Koch, M. Vrolix, A. IJsselmuiden, G. Amoroso, J. Berland, G. Montalescot, E. Teiger, E. H. Christiansen, R. Spaargaren, and W. Wijns|
|Journal||EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology|
|Date Published||2016 Feb 12|
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.