Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Apr 28;18(8):988-997.
doi: 10.1016/j.jcin.2025.01.426. Epub 2025 Feb 26.

Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT

Shigeru Saito  1 , Johan Bennett  2 , Holger M Nef  3 , Mark Webster  4 , Atsuo Namiki  5 , Akihiko Takahashi  6 , Tsunekazu Kakuta  7 , Seiji Yamazaki  8 , Yoshisato Shibata  9 , Douglas Scott  10 , Mathias Vrolix  11 , Madhav Menon  12 , Helge Möllmann  13 , Nikos Werner  14 , Antoinette Neylon  15 , Zlatko Mehmedbegovic  15 , Pieter C Smits  15 , Marie-Claude Morice  15 , Stefan Verheye  16 ; BIOADAPTOR-RCT Collaborators
Affiliations
Free article
Randomized Controlled Trial

Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT

Shigeru Saito et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: The sirolimus-eluting bioadaptor is a novel coronary implant that unlocks, separates, and maintains dynamic support of the vessel at the lesion site 6 months after percutaneous coronary intervention when the polymer coating covering the helical strands resorbs. This enables the bioadaptor to maintain the established flow lumen and to restore hemodynamic modulation of the artery, including cyclic pulsatility, vasomotion, and adaptive remodeling.

Objectives: The purpose of this study was to report the first randomized clinical evidence of the DynamX bioadaptor implant through 2 years compared with the Resolute Onyx contemporary drug-eluting stent.

Methods: This multicenter, single-blind, 1:1 randomized clinical trial was conducted at 34 hospitals in Japan, Europe, and New Zealand. The eligibility criterion was de novo coronary lesions in up to 2 vessels. The sample size was based on the primary endpoint, noninferiority of 12-month target lesion failure (TLF). The authors herein report 2-year outcomes.

Results: In total, 445 patients were enrolled; 3 patients treated for in-stent restenosis and 2 who did not receive the assigned study device because of randomization error were excluded from the analysis. In the per-protocol population of patients with de novo native coronary lesions treated with the assigned device (n = 440), 2-year Kaplan-Meier estimates of TLF and target vessel failure rates in the bioadaptor group were lower (1.8% [4 of 219] vs 5.5% [12 of 221], risk difference -3.6% [95% CI: -7.8% to -0.0%; P = 0.044], and 1.8% [4 of 219] vs 5.9% (13 of 221), risk difference -4.1% [95% CI: -7.2% to -1.0%; P = 0.027], respectively). One clinically driven target lesion revascularization occurred between 6 months and 2 years in the bioadaptor group, whereas 2 cardiovascular deaths and 4 clinically driven target lesion revascularizations occurred in the drug-eluting stent group. The 2-year rate of definite or probable device thrombosis was 0.0% vs 0.5% (n = 1) (P = 0.32), respectively.

Conclusions: This is the first report of 2-year outcomes comparing the bioadaptor implant with a contemporary drug-eluting stent. At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor. (The Elixir Bioadaptor vs. the Onyx Stent in De Novo Native Coronary Arteries [BIOADAPTOR RCT]; NCT04192747).

Keywords: bioadaptor; coronary artery disease; drug-eluting stent(s); hemodynamic modulation; percutaneous coronary intervention.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Elixir Medical. Dr Saito has received consulting fees from Elixir Medical, which are paid to the NPO International TRI network. Dr Bennett has received institutional consulting fees from Biotronik, Boston Scientific, Medtronic, Terumo, and Elixir Medical; and is an advisory board member for Elixir Medical. Dr Nef has received research grants, consulting fees, and honoraria from Elixir Medical. Dr Webster has received research payments to his institution. Dr Möllmann has received consulting fees from Boston Scientific; has received payments or honoraria from Abbott, Boston Scientific, and Edwards Lifesciences; and has received support for attending meetings from Boston Scientific. Dr Werner has received consulting fees and travel grants from Elixir Medical; and is an advisory board member for Elixir Medical, Shockwave Medical, and Abiomed. Dr Neylon is a shareholder of the Cardiovascular European Research Center. Dr Mehmedbegovic is an independent core laboratory specialist at the Cardiovascular European Research Center. Dr Smits has received institutional research grants from Abbott Vascular, SMT, MicroPort, and Daiichi-Sankyo; has received consulting fees from Abbott Vascular, AstraZeneca, Terumo, and MicroPort; has received payments or honoraria from Abiomed, Terumo, and MicroPort; participates on data and safety monitoring boards of the Protector, Legacy, and ASET Japan trials, the global advisory board of Abbott, and the European advisory board of Terumo (the latter paid to his institution); and is a minor shareholder of the Cardiovascular European Research Center. Dr Morice is a shareholder of Electroducer; and is a shareholder and CEO of the Cardiovascular European Research Center. Dr Verheye has received consulting fees and payments or honoraria from Elixir Medical and Shockwave Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publication types

MeSH terms

Associated data