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

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).