Similar performance, outcomes with drug-eluting adaptable implant vs. DES: BIOADAPTOR
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Key takeaways:
- A novel coronary scaffold technology was noninferior to a drug-eluting stent for target lesion failure at 12 months.
- The adaptable scaffold demonstrated superior restoration of vessel motion and function.
A drug-eluting coronary implant adaptable to vessel physiology with uncaging elements was safe and effective compared with a contemporary drug-eluting stent, demonstrating superior restoration of vessel motion and function, data show.
After stent implant, device-related adverse events continued to accrue after the first year at a rate of 2% to 3% per year, with no difference between second-generation DES, first-generation DES and bare-metal stents, Shigeru Saito, MD, director of the division of cardiology and catheterization laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, said during a late-breaking clinical data presentation at EuroPCR. Bioresorbable scaffolds, Saito added, “failed to live up to [their] promise” of improving short- or long-term outcomes compared with DES, driven by poor acute performance and loss of long-term vessel dynamic support.
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The drug-eluting bioadaptor implant (DynamX bioadaptor scaffold, Elixir Medical) “addresses the shortcomings of DES and bioresorbable scaffolds” by demonstrating restoration of vessel pulsatility, motion and function by uncaging the vessel, Saito said.
For BIOADAPTOR, a randomized controlled trial, Saito and colleagues assessed the safety, efficacy and acute performance of the DynamX bioadaptor (n = 223) against the Resolute Onyx DES (n = 222) for the treatment of ischemic heart disease due to de novo, native coronary lesions. The mean age of patients was 67 years; 22% were women. The primary endpoint was noninferiority for target lesion failure at 12 months, with clinical follow-up at 5 years. Secondary endpoints included intravascular imaging outcomes.
Acute performance was equivalent between the two devices, Saito said. For the primary endpoint of TLF, noninferiority was met, with event rates of 1.8% with DynamX and 2.8% with DES, a 35% difference (P < .001). Event rates across individual components of TLF were low. There were no cardiac deaths in the DynamX arm.
In a stationary IVUS pulsatility paired analysis measured across at least three cardiac cycles (n = 100), post-implant pulsatility was constrained in both arms, Saito said, noting that pulsatility remained constrained with DES at 12 months; however, pulsatility was restored in the DynamX arm (P < .001).
“DES continued to have compliance mismatch,” Saito said.
There was no change in blood flow at 12 months for DES; however, blood volume increased significantly for DynamX patients as pulsatility was restored (P < .001), Saito said.
The bioadaptor was also more effective at maintaining an open lumen at 12 months compared with DES, with percent diameter stenosis at 12.7% vs. 17.3% (P = .051) and late lumen loss being lower at 0.09 mm for the DynamX compared with 0.25 mm for the DES (P = .038).
In post hoc analyses of the IVUS cohort, in-device plaque volume increased by 3% in the DynamX arm and by 12% in the DES arm (P = .032), which Saito called a novel finding. Most patients were prescribed lipid-lowering therapies for secondary prevention, Saito said.
“A novel finding of plaque stabilization and regression shows a promising potential of DynamX on coronary atherosclerosis,” Saito said.
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Saito S, et al. Late-breaking clinical data: Focus on stent technology. Presented at: EuroPCR; May 16-19, 2023; Paris (hybrid meeting).
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