Stents (Bare-metal, Drug-eluting)
An Evaluation of a Sirolimus-Eluting Bioadaptor as Compared to a Zotarolimus-Eluting Stent in De Novo Coronary Arteries - “The Bioadaptor RCT Study”
Shigeru Saito1, Holger Nef2, Mark Webster3, Stefan Verheye4
Shonan Kamakura General Hospital, Japan1, University of Giessen, Germany2, Auckland City Hospital, New Zealand3, ZNA Middelheim, Belgium4
The DynamX Drug-Eluting Coronary Bioadaptor design incorporates uncaging elements which disengage at 6months through resorption of the bioresorbable polymer coating, thereby uncaging the vessel and restores vessel function. This arterial uncaging allows for restoration of vessel compliance, pulsatility and positive adaptive remodeling.
The Bioadaptor Study is a prospective, randomized, single-blind, non-inferiority study, powered for the primary endpoint of Target Lesion Failure (TLF) at 1 year. The study will include 444 subjects with ≤ 2 de novo coronary lesions at 35 sites in Japan, Europe and New Zealand. The Japanese and European cohorts will each randomize 222 subjects, 1 : 1 (DynamX Bioadaptor : Resolute Onyx). The Japan cohort will include imaging subsets with angiography / IVUS at baseline and 12 months (n = 80),and angiography / IVUS / OCT at baseline and 12 months (n = 20). Japan will also enroll a non-randomized, 8-subject PK sub-study. All subjects will be followed at 1, 6 and 12 months, and annually through 5 years. Key inclusion criteria: up to 2 de novo lesions in up to 2 separate native coronary arteries, target lesion diameters of 2.25 to 4.0 mm and ≤ 34 mm in length. Key exclusion criteria: AMI < 72 hours prior, left main lesions and CTOs. Dual anti-platelet therapy given per DES guidelines. Events will be adjudicated by an independent CEC; imaging will be analyzed by Core Laboratory. Monitoring of clinical sites will be conducted throughout the study.
Enrollment completion is expected Q4 2021. To date, over 300 subjects, including 6 PK, are enrolled (10/2021). The ability to restore positive remodelling, arterial rotation, pulsatility, and a return towards baseline vessel angulation has been reported in the DynamX Mechanistic study proving the Bioadaptor benefit.
This randomized trial will support the safety and efficacy of the DynamX Bioadaptor compared to a contemporary drug-eluting stent with data to verify if the impact of uncaging on vessel function offers meaningful long-term benefit. The study is anticipated to be completely enrolled and an update will be presented during the meeting.