Written by Mary Marschner
Spoon Feed
A third-generation stent designed to maintain pulsatility was noninferior to a second generation DES in the first year after placement.
Synopsis
This single-blind, registry-based, randomized controlled trial, conducted in 20 Swedish hospitals, compared the DynamX bioadaptor to a contemporary drug-eluting stent (DES) in 2,399 patients undergoing percutaneous coronary intervention (PCI) for de novo coronary lesions. The bioadaptor demonstrated non-inferiority for 12-month target lesion failure (2.4% vs. 2.8%, p<0.0001) and showed significant reductions in target lesion failure from 6 to 12 months (HR 0.19, p=0.0079). Secondary findings included improved outcomes in acute coronary syndrome subgroups. These results suggest the bioadaptor may reduce non-plateauing device-related events, offering a promising alternative for PCI, pending further long-term outcome verification. (AI-assisted)
INFINITY-SWEDEHEART – the new sweetheart of the coronary artery stents?
Continuing the journey of learning about the next generation of cardiac stents, this one has a novel design that allows it to become flexible. When initially placed, it is rigid, like current generation stents, but it contains biodegradable polymer that, once degraded after 6 months, reveals joints that allow the stented area to move, constrict, and expand like a native vessel. The goal of this next generation of stents is to improve on the need for revascularization due to target lesion failure (i.e. stenosis at the site of a previously placed stent) and late-stage thrombosis, both of which are thought to occur due to vessel inflammation, delayed vessel healing, hypersensitivity reactions, and neo-atherosclerosis. This study is one more non-inferiority design that shows promise; the novel study performs well against second generation DES at 1 year. They did an additional analysis from 6-12 months which is suggestive that the bioadaptive stent outperforms once the polymer degrades; it was statistically significant but limited due to a low number of patients. I’m excited to see the next, longer-term, study, but I am also very impressed at the detailed subanalysis done for types of lesions, location of lesions, and calcium scores that were thoughtfully done. My takeaway is the same; we may start to see new stents soon that are cool, but no changes to current management from Internists.
Source
Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial. Lancet. 2024 Nov 2;404(10464):1750-1759. doi: 10.1016/S0140-6736(24)02227-X. Epub 2024 Oct 28. PMID: 39481425
