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DANCE-ATX: Dexamethasone micro-infusion beneficial in atherectomy
LAS VEGAS — Adventitial drug delivery with dexamethasone conferred positive 2-year outcomes in patients with peripheral artery disease who underwent atherectomy, according to a presentation from VIVA 17.
The researchers investigated whether using a micro-infusion device (Bullfrog, Mercator MedSystems) to reduce inflammation by administering dexamethasone to the adventitia would benefit patients with lesions in the superficial femoral or popliteal arteries.
One-year results for the atherectomy and percutaneous transluminal angioplasty cohorts were previously reported. George Adams, MD, director of cardiovascular and peripheral vascular research at Rex Hospital and clinical associate professor of medicine at the University of North Carolina, Chapel Hill, presented 2-year results from the 157 patients in the atherectomy cohort (mean age, 68 years; 57% men; 17% black).
“Dexamethasone is a strong, locally acting steroid that is known to decrease local inflammation,” Adams said during a presentation. “Adding dexamethasone in the DANCE trial has yielded high long-term patency and low clinically driven target lesion revascularization rates, with a strong safety profile.”
At 2 years, 13.2% of patients died, and 8.5% of the cohort died from CV or unknown causes, Adams said.
At 2 years, the per-protocol Kaplan-Meier estimate of primary patency was 72.8%; among those who had a stent implanted, it was 80.7%, whereas among those who did not, it was 69.2%, he said.
In men, 2-year primary patency was 75.3% vs. 69.4% for women; the rate for orbital atherectomy was 76.6% vs. 68.7% for directional atherectomy, according to the researchers. Rotational and laser atherectomy devices were also used, but not commonly, Adams said.
The 2-year per-protocol Kaplan-Meier estimate of freedom from clinically driven TLR was 85.2%. Adams said.
Researchers are currently enrolling patients in the LIMBO-PTA and LIMBO-ATX studies of dexamethasone infused by the Bullfrog device in patients with below-the-knee lesions, and the TANGO study of temsirolimus infused by the Bullfrog device in patients with below-the-knee lesions, Adams said. In the planning stages are TWIST, in which the device will administer both agents; PRT-201-115, in which it will administer vonapanitase (Proteon Therapeutics); and a study of the device administering stem cells, he said.
“Endovascular intervention, regardless of what intervention you use, results in the inflammatory process being activated, ultimately causing a restenotic pattern,” Adams said during a presentation. “Adventitial infusion and targeting of inflammation represent an appropriate pathway to maintain long-term patency across multiple subgroup analyses. It may require a different biologic to treat different patient subgroups. We’re committed to evaluating different biologics using the Bullfrog platform.” – by Erik Swain
Disclosure: The study was funded by Mercator MedSystems. Adams reports financial ties with Abbott Vascular, Asahi, Bard Peripheral Vascular, Boston Scientific, Cardinal Health, Cardiovascular Systems Inc., CloSys, Control Medical, Cook Medical, Cordis, Daiichi Sankyo, IDEV Technologies Inc., Intact Vascular, Juventas, Lutonix, Medtronic, Mercator MedSystems, Merit Medical, PQ Bypass, Penumbra, Philips, Prairie Education & Research Cooperative, Siemens, Shockwave Medical, Spectranetics, St. Jude Medical, Syntervention, Terumo, TriVascular, VEITH Symposium, Volcano and W.L Gore and Associates.