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

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• The sirolimus-eluting bioadaptor is a novel coronary implant designed to maintain vessel dynamics post-percutaneous coronary intervention.
• It aims to restore hemodynamic modulation, including pulsatility and vasomotion, after the polymer coating resorbs.

Purpose of the Study:

• To present the first randomized clinical trial data comparing the DynamX bioadaptor implant with the Resolute Onyx drug-eluting stent.
• To evaluate the 2-year clinical outcomes of the DynamX bioadaptor.

Main Methods:

• A multicenter, single-blind, 1:1 randomized clinical trial involving 34 hospitals across Japan, Europe, and New Zealand.
• The study included patients with de novo coronary lesions, with target lesion failure (TLF) at 12 months as the primary endpoint.
• Two-year outcomes are reported for the per-protocol population (n=440).

Main Results:

• The DynamX bioadaptor group showed significantly lower rates of TLF (1.8% vs 5.5%) and target vessel failure (1.8% vs 5.9%) at 2 years compared to the Resolute Onyx stent.
• Fewer revascularization events were observed in the bioadaptor group between 6 months and 2 years.
• No definite or probable device thrombosis was reported in the bioadaptor group versus 0.5% in the stent group.

Conclusions:

• The DynamX bioadaptor implant demonstrated superior efficacy compared to the contemporary Resolute Onyx drug-eluting stent at 2-year follow-up.
• Fewer target lesion failure events were observed in patients treated with the bioadaptor.
• This study provides the first 2-year outcomes comparing the bioadaptor to a drug-eluting stent.