STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial.

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.

• Authors: 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
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 11 Issue 11 Pg. e1267-74 (Feb 2016) ISSN: 1969-6213 [Electronic] France
• PMID: 26865444 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• zotarolimus
• Sirolimus

Topics

• Aged
• Angioplasty, Balloon, Coronary (methods)
• Coronary Angiography (methods)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (drug therapy, surgery)
• Percutaneous Coronary Intervention (methods)
• Sirolimus (analogs & derivatives, therapeutic use)
• Treatment Outcome