APPOSITION IV Data Published for the Stentys Self-Apposing Stent in STEMI Patients

February 15, 2016—Robert-Jan M. Van Geuns, MD, et al published results from the randomized APPOSITION IV trial in the online e-edition of EuroIntervention (2016;11:e1267–e1274).

As summarized in EuroIntervention, the trial was conducted 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 (ZES) in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).

In the APPOSITION IV trial, 152 STEMI patients were randomized (3:2) to the Stentys device or to a commercially available ZES at 12 sites in five countries with angiographic follow-up and optical coherence tomography at 4 or 9 months. At 4 months, a lower percentage of malapposed stent struts was observed in the Stentys group (n = 21; 501 struts) compared with controls (n = 26; 326 struts) (0.07% vs 1.16%; P = .002) with significantly more covered struts, using a 20-µm cut-off (94.32% vs 89.09%; P = .003). At 9 months, the primary endpoint (percentage malapposed stent struts) was similar in both groups (Stentys, n = 40, 566 struts; control, n = 21, 292 struts), showing complete apposition (P = .55) and near total (> 96%) coverage (P = .58).

In STEMI patients undergoing primary PCI, 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 9 months; however, stent strut apposition and coverage at 4 months were significantly better in the Stentys group, concluded the investigators in EuroIntervention.

In May 2014, Stentys announced the presentation of the APPOSITION IV data at EuroPCR conference in Paris, France.