Drug-filled stent promotes vessel healing at 1 month
CHICAGO — Patients who received a novel drug-filled stent showed rapid vessel healing at 1 month, according to data presented at the American College of Cardiology Scientific Session.
According to the study background, the drug-filled stent (DFS, Medtronic) uses no polymer, which could reduce risk for inflammation and enable shorter duration of dual antiplatelet therapy after stenting. Instead, it controls and sustains drug elution through natural diffusion via direct contract with the wall of a vessel.
The researchers presented 1-month data from 13 of the first 15 patients in the RevElution trial, a 50-person cohort of patients with ischemic coronary disease used to support a CE mark in Europe.
“The unique attribute of DFS technology is that it allows for controlled elution of a drug directly from within a next-generation stent, obviating the need for a polymer,” Ajay J. Kirtane, MD, SM, FACC, FSCAI, director of the cath lab at NewYork-Presbyterian Hospital/Columbia University, associate professor of medicine at Columbia, co-director of Transcatheter Cardiovascular Therapeutics for the Cardiovascular Research Foundation and Cardiology Today’s Intervention Editorial Board member, said in a press release.
Ajay J. Kirtane
According to an OCT assessment at 1 month, mean neointimal hyperplasia thickness was 60 µm, mean neointimal hyperplasia area was 0.46 mm2 and mean percent obstruction was 5.83%.
The researchers reported that mean strut coverage was 89.5% (median, 91.4%; 95% CI, 84.8-93.2), whereas the rate of malapposed struts was 1.5% (median, 0.3%; 95% CI, 0-2.3), down from 4.92% after the procedure (P = .002). Poor strut coverage (uncovered-to-total-strut ratio > 30%) is a risk factor for stent thrombosis, according to the study background.
At 1 month, the DFS showed improvement in incomplete stent apposition volume (P = .008), frequency of frames with any malapposed strut (P < .001), maximum length of consecutive segments with incomplete stent apposition (P < .001) and total length of segments with incomplete stent apposition (P = .001), according to the researchers.
“If the encouraging early data from the RevElution trial continue to show promise with longer-term follow-up, they will set the stage for further pivotal investigations of the DFS,” Kirtane said in the release. “Furthermore, the ability to potentially reduce the mandatory duration of [DAPT] following DFS implantation is vitally important for patients and treating physicians.”
The researchers stated they hope to report primary endpoints from the trial at TCT 2016. – by Erik Swain
Worthley SG, et al. Poster 1256-175. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.
Disclosure: The study was funded by Medtronic. Kirtane reports receiving research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, GlaxoSmithKline, Medtronic and St. Jude Medical. Other researchers report financial ties with Abbott Vascular, Ablative Solutions, AstraZeneca, Bayer, Biosensors, Biostar family funds, Biotronik, Boston Scientific, Cagent, Caliber, Guided Delivery Systems, HeartFlow, Matrizyme, Medfocus family funds, Medtronic, Micardia, Miracor, Neovasc, Qool Therapeutics, Reva, St. Jude Medical, TherOx, Toray, Vascular Dynamics, Vascular Nonotransfer Technologies and V-Wave.