Elixir Medical announced two-year results from the Bioadaptor Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results, for the first time, demonstrate significant reduction in adverse events and clinical advantage of the DynamX bioadaptor in target lesion failure (TLF) and secondary endpoint of target vessel failure (TVF) driven by sustained low event rates with DynamX compared to a two-fold increase in DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris.
Clinical results show statistically significant benefit with DynamX bioadaptor over Resolute Onyx at two years:
- 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046). The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX compared to DES, respectively:
1. Cardiovascular death (0% versus 1.8%)
2. Target vessel myocardial infarction (0.9% versus 1.9)
3. Target lesion revascularization (0.9% versus 2.3%)
4. 68% reduction in TVF rate (1.9% versus 6.0%; p=0.029) in DynamX compared to DES
- Two-year lesion subset results:
1. 78% reduction (1.9% vs.8.7%; p=0.028) in TLF rate in left anterior descending (LAD) artery lesions treated with DynamX bioadaptor versus treatment with DES
2. Small vessels (<2.75mm) TLF rate was 0% vs. 3.5% in DynamX versus DES, respectively
3. Long lesions (>23mm) TLF rate was 0% vs. 2.3% in DynamX versus DES, respectively
"These two-year results from the BIOADAPTOR RCT trial are very exciting—unlike anything we’ve ever seen before—and represent a new treatment category for patients living with coronary artery disease. The TLF rate curve separation validates how the bioadaptor’s unique design and mechanism of action restores the vessel viability, including the LAD vessel. It does this by restoring hemodynamic modulation validating the previously demonstrated superior imaging outcomes at one year. These data show that bioadaptor offers sustained, very low event rates across all major endpoints, making it a superior option compared to DES," said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. "The 78% magnitude of reduction in clinical events in LAD lesions is particularly important, as the artery provides 50% of a heart muscle’s blood supply and undergoes significant hemodynamic movement during every cardiac cycle. Restoring its function is clearly of significant benefit."
Prof. Thach Nguyen - committee member of the American Heart Association and Society for Cardiovascular Angiography and Intervention, shared: "I was very impressed with the 2-year follow-up results of the DynamX Bioadaptor compared to a drug-eluting stent. The clinical results showed that the rate of restenosis and other cardiovascular complications after two years was very good, at only 1.9%. This trial was led by Dr. Saito, an expert and passionate about scientific research, so these results are very reliable and offer great hope for cardiovascular patients in the near future. Dr. Saito has also visited Vietnam multiple times to share his experience, so I am hopeful that more Vietnamese people will be treated with this advanced technology."
The DynamX bioadaptor is different from current standard of care therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. The locked phase establishes maximum flow lumen and restores blood flow. Unique to bioadaptor, the unlocked and separation phase of bioadaptor’s helical strands releases the vessel while maintaining the established blood flow lumen. The final phase provides adaptive dynamic support after the unlocking and separation phase to restore vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has shown evidence of plaque stabilization and regression in the lesion.
"We are beyond thrilled with these findings from the BIOADAPTOR RCT," said Motasim Sirhan, CEO of Elixir Medical. "Never before have we seen a vascular technology that addresses the limitations of existing revascularization therapies by restoring artery hemodynamic modulation and stabilizing or regressing plaque volume, as we have with DynamX bioadaptor. These exceptional patient clinical outcomes further validate that the bioadaptor is truly a transformative technology for coronary artery disease treatment."
