Elixir Medical’s DynamX Bioadaptor Evaluated in 2-Year BIOADAPTOR Data

May 20, 2024—Elixir Medical announced 2-year results from the BIOADAPTOR randomized controlled trial (RCT), which is comparing Elixir’s DynamX sirolimus-eluting coronary bioadaptor system to the standard-of-care Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic).

The results demonstrated a significant reduction in adverse events and a clinical advantage of the DynamX bioadaptor in target lesion failure (TLF) and the secondary endpoint of target vessel failure (TVF), driven by sustained low event rates with DynamX compared to a twofold increase with DES, stated the company.

The data were presented at EuroPCR 2024, held May 14-17 in Paris, France.

The company noted that the BIOADAPTOR RCT is composed of 445 patients enrolled at 34 centers in Japan, Europe, and New Zealand who were randomized 1:1. Both arms had large, randomized multimodality imaging subgroups of 50 patients each.

The subgroups documented standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis and late lumen loss, as well as new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through 5 years.

According to the company, the clinical results showed the following statistically significant benefits with DynamX bioadaptor versus Resolute Onyx at 2 years:

• 65% reduction in TLF rate (1.9% vs 5.5%; P = .046), driven by low adverse events across all components of the composite endpoint: cardiovascular death (0% vs 1.8%), target vessel myocardial infarction (0.9% vs 1.9), and target lesion revascularization (0.9% vs 2.3%)
• 68% reduction in TVF rate (1.9% vs 6%; P = .029).

The 2-year lesion subset results with the DynamX bioadaptor versus DES included:

• 78% reduction (1.9% vs 8.7%; P = .028) in TLF rate in left anterior descending (LAD) artery lesions
• Small vessel (< 2.75 mm) TLF rate of 0% v 3.5
• Long lesion (> 23 mm) TLF rate of 0% vs. 2.3%

Shigeru Saito, MD, Director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, commented on the findings in Elixir’s press release.

“These 2-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,” stated Dr. Saito. “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 1 year.”

Dr. Saito continued, “These data show that [the] bioadaptor offers sustained, very low event rates across all major endpoints, making it a superior option compared to DES. 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.”

The DynamX coronary bioadaptor system has received European CE Mark approval. It is not available for sale in the United States, advised the company.