TCT 2025 | INFINITY–SWEDEHEART: Long-Term Outcomes of the Bioadaptive Coronary Implant Versus Drug-Eluting Stent

The bioadaptive coronary implant DynamX (Elixir Medical, California) was developed to restore normal vascular function after angioplasty, combining a cobalt-chromium helical structure with bioresorbable connectors that, upon degradation after six months, allow the vessel to regain its pulsatility and adaptive response.

The INFINITY–SWEDEHEART trial was a prospective, randomized, multicenter, controlled study conducted across 20 centers in Sweden. It compared the sirolimus-eluting bioadaptor to a reference everolimus-eluting stent (Resolute Onyx). A total of 2,400 patients were enrolled (1,201 bioadaptor; 1,198 DES) in a 1:1 randomization design.

The primary endpoint was target lesion failure (TLF) at 12 months, with the objective of demonstrating non-inferiority. Statistically powered secondary endpoints included TLF, target vessel failure (TVF), and TLF in acute coronary syndrome (ACS) patients between 6 and 24 months.

At two years, the bioadaptor demonstrated a 48% reduction in TLF between 6 and 24 months compared with DES (HR 0.52; 95% CI 0.29–0.93; p = 0.027). A significant improvement was also observed in TVF (p = 0.0481), with an even greater benefit among ACS patients (p = 0.0175).

Read also: TCT 2025 | SUMMIT-MAC: Transcatheter Mitral Valve Replacement with the Tendyne System in Patients with Severe Annular Calcification.

The reduction in events was consistent across all components of the composite endpoint — cardiac death, target-vessel MI, and revascularization — with no increase in thrombosis, device-related complications, or major adverse events.

Conclusions

The DynamX bioadaptive stent showed a sustained reduction in device-related events from 6 to 24 months, with particularly pronounced benefits in ACS patients. It is the first device to demonstrate significant improvement over contemporary drug-eluting stents, establishing a new paradigm in coronary intervention by combining safety, efficacy, and functional vessel restoration.

Presented by David Erlinge on behalf of the INFINITY–SWEDEHEART Investigators. TCT 2025 (Late-Breaking Clinical Trials), October 27, San Francisco, USA.