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

Summary

In a multicenter, single-blind RCT (n=440 per-protocol) of de novo lesions, the sirolimus-eluting bioadaptor reduced 2-year target lesion failure (1.8% vs 5.5%; P=0.044) and target vessel failure (1.8% vs 5.9%; P=0.027) compared with a contemporary drug-eluting stent, with no increase in definite/probable device thrombosis (0% vs 0.5%). The design aims to restore arterial hemodynamics after polymer resorption.

Key Findings

• 2-year TLF was lower with bioadaptor vs DES (1.8% vs 5.5%; risk difference −3.6%; P=0.044).
• 2-year target vessel failure was reduced with bioadaptor (1.8% vs 5.9%; risk difference −4.1%; P=0.027).
• Definite/probable device thrombosis was not increased (0% vs 0.5%; P=0.32).

Clinical Implications

For suitable de novo lesions, bioadaptor implants may offer lower 2-year TLF/TVF with maintained safety, potentially shifting device selection in PCI toward physiology-restoring scaffolds pending broader confirmation.

Limitations

• Per-protocol analysis excludes some randomized patients; potential bias vs ITT.
• Modest sample size limits rare safety event detection and subgroup granularity.

Future Directions

Larger, ITT-focused RCTs with diverse anatomies and imaging endpoints, plus head-to-head comparisons versus new-generation DES, to confirm durability, vasomotion restoration, and clinical benefit.