Dr. Murat Demirci

Name of the study:  1-Year and Landmark 6-12 Month Clinical Outcomes from the INFINITY-SWEDEHEART Randomized Clinical Trial
Published in Congress:  TCT 2024, Presenter: David Erlinge

Link: https://www.tctmd.com/slide/1-year-and-landmark-6-12-month-clinical-outcomes-among-patients-complex-lesion-subsets

Introduction: In stent therapies, adverse events persist at a rate of 2-3% annually starting from the first year. In this context, the DynamX bioadaptor implant has been developed as an innovative technology aimed at restoring long-term vascular function by preserving the pulsatile and compliant properties of vessels, in contrast to conventional drug-eluting stents (DES). The DynamX bioadaptor is composed of three helical structures made from cobalt-chromium, which are held together by a temporary bioresorbable polymer coating. During the first six months post-implantation, the device releases an antiproliferative agent to support tissue healing while maintaining vessel patency. In this period, the bioresorbable coating keeps the device in a “locked” position to stabilize the vessel wall and preserve the intravascular space. After six months, the coating fully degrades, allowing the helical structures of the device to transition into an “unlocked” position. At this stage, the bioadaptor facilitates the recovery of vessel pulsatility, enhancing the natural vascular elasticity.

Objective: The objective is to compare the safety and efficacy of the bioadaptor implant with traditional drug-eluting stents (DES), to assess its potential in reducing event rates beyond 6 months, and to evaluate the clinical advantages it offers for high-risk patient groups.

Methods: This multicenter randomized controlled trial, conducted across 20 centers in Sweden, includes a total of 2,400 patients. Patients diagnosed with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require stent implantation via percutaneous coronary intervention (PCI) were enrolled. Patients with target lesions meeting the device's specifications for vessel diameter and lesion length were randomized in a 1:1 ratio to the bioadaptor and DES groups. The primary endpoint is target lesion failure (TLF) at one-year follow-up. Secondary endpoints are defined as target lesion failure (TLF) and target vessel failure (TVF) within the 6- to 12-month follow-up period.

Results: At the one-year follow-up, the target lesion failure (TLF) rate was found to be 2.4% in the bioadaptor group and 2.8% in the DES group, confirming the safety of the bioadaptor (p<0.0001). In analyses conducted beyond six months, significant reductions in both target lesion failure (TLF) and target vessel failure (TVF) rates were observed in favor of the bioadaptor implant (p=0.008 and p=0.011, respectively). Additionally, clinical benefits of the bioadaptor were observed in patients with acute coronary syndrome (ACS), lesions in the left anterior descending artery (LAD), and small-diameter vessels.

Conclusion: The INFINITY-SWEDEHEART study demonstrates that the bioadaptor implant offers significant clinical advantages over traditional DES in complex lesion subgroups and may be effective in reducing long-term complications, especially in high-risk patient groups. These findings suggest that the bioadaptor could be considered a potential therapeutic option in the future for lowering event rates and maintaining long-term vascular function following percutaneous coronary interventions.

Comment: The bioadaptor implant represents a significant innovation in preserving long-term vascular function and reducing complications. Unlike traditional drug-eluting stents (DES), bioadaptor technology supports vascular health in the long term by restoring vessel pulsatility and compliance after six months, allowing natural movements of the vessel wall to be maintained. The study’s results confirm the clinical benefits of the bioadaptor, particularly in high-risk patient groups, and suggest that this implant may serve as a strong alternative for reducing long-term coronary events. This technology may pave the way for more personalized treatment approaches in managing patients with chronic and acute coronary syndromes, marking a breakthrough in protective treatment strategies aimed at preserving vascular function.