Adaptable implant improves outcomes vs. drug-eluting stent at 2 years in patients with CAD
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Key takeaways:
- A novel drug-eluting coronary implant conferred better outcomes than a drug-eluting stent at 2 years in patients with coronary artery disease.
- The device was able to restore hemodynamic modulation.
A drug-eluting coronary implant adaptable to vessel physiology with uncaging elements was linked to less target lesion failure and target vessel failure at 2 years compared with a drug-eluting stent, researchers reported.
As Healio previously reported, at 1 year of the BIOADAPTOR randomized controlled trial (RCT), the drug-eluting bioadaptor implant (DynamX bioadaptor scaffold, Elixir Medical) was noninferior to a DES (Resolute Onyx, Medtronic) for target lesion failure. Shigeru Saito, MD, director of the division of cardiology and catheterization laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, presented 2-year results at EuroPCR.
“The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance and adaptive increase in blood flow volume, and providing plaque stabilization and regression,” Saito told Healio. “It has a unique mechanism of action which addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds with remarkably low clinical event rates that showed a plateau between 1-year and 2-year clinical follow up. Unlike traditional DES, the bioadaptor works with the vessel to allow the vessel to pulsate, bend and twist, restoring and increasing blood flow and enabling the vessel to act more like it would in its natural state — indicative of healthy artery function.”
The novel device consists of three cobalt chromium helical sinusoidal strands that are temporarily locked and held by a bioresorbable polymer to establish flow lumen, which are unlocked 6 months after polymer resorption to maintain flow lumen, Saito said, noting that the technology offers dynamic adaptive support after unlocking and separating to restore hemodynamic modulation.
The trial consisted of 445 patients with CAD (mean age, 67 years; 22% women) from 34 centers in Belgium, Germany, Japan and New Zealand.
In the intention-to-treat population, the primary outcome of target lesion failure favored the bioadaptor over the DES to a greater extent at 2 years (2.3% vs. 5.5%; HR = 0.41; 95% CI, 0.14-1.16; P = .093) than it did at 1 year, and in the per-protocol population, target lesion failure was reduced at 2 years in the bioadaptor group compared with the DES group (1.9% vs. 5.5%; HR = 0.35; P = .046), Saito said during the presentation.
Also in the per-protocol population, the bioadaptor group had a 78% lower rate of target lesion failure in left anterior descending artery lesions (1.9% vs. 8.7%; P = .028) and a 68% lower rate of target vessel failure (1.9% vs. 6%; P = .029) at 2 years compared with the DES group, he said.
“The 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,” Saito told Healio. “The target lesion failure 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. These data show that 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 bioadaptor has been established as a new therapy. Given its performance establishing it as a superior option to DES, it has the potential to become a new standard of treatment for patients with CAD.”
For more information:
Shigeru Saito, MD, can be reached at transradial@kamakuraheart.org.
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Saito S, et al. Hotline: New coronary devices. Presented at: EuroPCR; May 14-17, 2024; Paris.
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