The STENTYS Self-Expanding Drug-Eluting Stent in Coronary Bifurcation Lesions at 6 Months Follow-up: Results from the OPEN II Trial

Background: In bifurcation lesions (15-20% of PCIs), results of PCI with balloon expandable stents are often impaired by carina incomplete support, strut deformation, malapposition, or excessive metallic burden when treated with 2 stents. Dedicated stents were developed but they often require precise and difficult positioning or require to stent first the side branch. There is thus a need for an easy to use stent in most bifurcations and which follows guideline practice of main branch (MB) provisional stenting, supporting carina with minimal disruption of the side branch (SB) anatomy. The self-expanding STENTYS DES (Stentys, Paris, France) has disconnectable struts for side branch access and showed very high procedural success and low MACE rate in the OPEN I trial. Methods: The OPEN II prospective, multi-centric single-arm study assess the safety and efficacy at 6 and 12-months of the STENTYS Paclitaxel eluting stent in routine coronary bifurcation stenosis. Key exclusion criteria were Medina class 0,0,1, chronic total occlusion, unprotected left main, and STEMI as clinical presentation. SB stenting was left to operator's discretion. The primary endpoint of the study is MACE at 6 months follow-up. Secondary endpoints include MACE rate at 12 months, target vessel failure at 6 and 12 months, procedural success and parameters measured by QCA (MLD, DS%, .). An OCT substudy investigates stent apposition at the initial procedure timepoint. Results: 220 patients were enrolled in 21 European centers. Age was 66 ± 11 years, 78% male. Diabetes was present in 30% of patients, hypertension in 76%. Medina class 1,1,1 was found in 35% of the patients. STENTYS DES was implanted successfully in 98% of the patients. Stenting of SB was performed in 12% of the procedures. Revascularization was successful (TIMI 3 or 2) in 99.5% for MB, and 96.7% for SB. Conclusions: The ongoing Open II study is the largest study assessing self-expanding STENTYS DES in bifurcation lesions in a clinical routine setting. The primary endpoint, MACE rate at 6 months, will be presented, and compared to landmark trials (Nordic and BBC studies). TVF, QCA and OCT data will also be presented.