Coronary implant noninferior to DES at 1 year, tied to event reduction after 6 months
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Key takeaways:
- The bioadaptor implant adaptable to vessel physiology was noninferior to a DES for target lesion failure at 1 year.
- The bioadaptor was linked to fewer target lesion failure events after 6 months.
The bioadaptor implant adaptable to vessel physiology was noninferior to a drug-eluting stent for target lesion failure at 1 year, and reduced event rates vs. the DES after 6 months, researchers reported.
As Healio previously reported, the drug-eluting coronary implant (DynamX bioadaptor scaffold, Elixir Medical) in June received breakthrough device designation from the FDA. It is not yet approved for commercial use in the U.S.
For the INFINITY-SWEDEHEART trial, presented at the European Society of Cardiology Congress, researchers randomly assigned 2,400 patients with CAD (mean age, 68 years; 24% women) to undergo PCI with the drug-eluting coronary implant or a contemporary DES (Resolute Onyx, Medtronic).
‘A significant clinical advancement’
“The DynamX coronary bioadaptor system represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action of restoring hemodynamic modulation and physiology (vessel natural function) 6 months following the percutaneous coronary intervention procedure,” David Erlinge, MD, PhD, head of the cardiology department at Skane University Hospital, Lund, Sweden, who presented the results, told Healio. “The bioadaptor is a first-of-its-kind coronary implant designed to overcome the challenges of DES and bioresorbable scaffold technologies. It utilizes a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore normal vessel motion and function. The locked phase establishes maximum flow lumen and restores blood flow. During the unlocked phase, unique to the bioadaptor, at 6 months, the bioadaptor’s helical strands unlock and separate, releasing the vessel while maintaining the established blood flow lumen. The final phase provides adaptive dynamic support, restoring hemodynamic modulation including restoration of vessel pulsatility, compliance and adaptive coronary flow.”
The primary endpoint was noninferiority for target lesion failure, defined as CV death, target-vessel MI or ischemia-driven target lesion revascularization, at 1 year, and it was met (bioadaptor, 2.35%; DES, 2.77%; difference, –0.41 percentage points; 95% CI, –1.94 to 1.11; P for noninferiority < .001), Erlinge said during a press conference.
Landmark analysis
However, in a landmark analysis, the researchers determined that event curves started to separate after 6 months, and target lesion failure events between 6 months and 1 year were lower in the bioadaptor group (0.2% vs. 1.3%; log-rank P = .003), as were target vessel failure events (0.6% vs. 1.8%; log-rank P = .008).
“The trial results of bioadaptor strongly support the clinical impact in CAD treatment, with the potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,” Erlinge told Healio. “The technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery. Considering millions of people undergo PCI every year, the reduction in clinical events with the bioadaptor can have major impact on the lifetime management of our patients, and introduces a new clinical standard for our practice.”
The patients from this cohort will be followed for 5 years, he said.
For more information:
David Erlinge, MD, PhD, can be reached at david.erlinge@gmail.com.
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Erlinge D, et al. Hot line 11. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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