Bioadaptor may flatten event curve after PCI, including in complex lesions
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Key takeaways:
- A bioadaptor implant adaptable to vessel physiology conferred better outcomes from 6 months to 1 year vs. a DES.
- Patients with high-risk lesions experienced greater benefit after 6 months with the bioadaptor.
WASHINGTON — A bioadaptor implant adaptable to vessel physiology was linked to fewer target lesion failure events after 6 months compared with a drug-eluting stent, including in high-risk lesions, researchers reported.
As Healio previously reported, in the main results of the INFINITY-SWEDEHEART trial of patients with CAD requiring PCI, the implant (DynamX bioadaptor scaffold, Elixir Medical) was noninferior to a contemporary DES (Resolute Onyx, Medtronic) for target lesion failure at 1 year and reduced event rates vs. the DES after 6 months. David Erlinge, MD, PhD, head of the cardiology department at Skåne University Hospital in Lund, Sweden, presented new data from the landmark analysis from 6 months to 1 year, including in patients with high-risk lesions, at TCT 2024. The main results and the new data were simultaneously published in The Lancet.
“In a previous trial, BIOADAPTOR RCT, [we saw] flattening of event rates after 6 months” in patients who received the bioadaptor, Erlinge said at a press conference. “Six months is an important figure because that’s when the bioadaptor opens up and uncages, restoring physiology. When you first put it in, it acts exactly like one of the best-in-class drug-eluting stents. After 6 months, it unlocks, [enabling] the vessel to do positive remodeling.”
INFINITY-SWEDEHEART included 2,400 patients with CAD (mean age, 68 years; 24% women), some of whom had ACS and/or complex lesions, randomly assigned to the bioadaptor or the DES for PCI.
Erlinge presented the previously released data showing the primary endpoint of noninferiority for target lesion failure, defined as CV death, target-vessel MI or ischemia-driven target lesion revascularization, at 1 year, was met (bioadaptor, 2.35%; DES, 2.77%; difference, –0.41 percentage points; 95% CI, –1.94 to 1.11; P for noninferiority < .001), and that in a landmark analysis, target lesion failure events from 6 months to 1 year were lower in the bioadaptor group (log-rank P = .0079), as were target vessel failure events (log-rank P = .011).
In patients with ACS, from 6 months to 1 year, the bioadaptor group had fewer events than it did between baseline and 6 months (log-rank P = .018) but that was not the case for the DES group (log-rank P = .74; P for interaction = .023), Erlinge said at the press conference.
From 6 months to 12 months, the bioadaptor group had fewer events than the DES group in patients with lesions in the left anterior descending artery (log-rank P = .032), patients with small vessels, defined as 2.75 mm or less (log-rank P = .037) and patients with long lesions, defined as 22 mm or more (log-rank P = .053), he said.
“It seems like the bioadaptor after uncaging results in better outcomes than a standard drug-eluting stent,” Erlinge said at the press conference.
Reference:
Perspective
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Celina M. Yong, MD, MBA, MSc
These are exciting data. We are always looking for something that can help us achieve long-term low event rates. If we are able to flatten that curve in the long run, that would be a wonderful new technology. The results are promising.
We are always slower to get new devices in the U.S., but these huge trials will be helpful, and I am hopeful that we will get access to this technology.
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Erlinge D, et al. Late-breaking clinical science: Session I, in collaboration with the European Heart Journal. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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