DANCE Trial Evaluates Adventitial Drug Delivery of Dexamethasone to Treat Femoropopliteal PAD Adjunctive to Endovascular Therapy
May 30, 2018—Twelve-month results from the DANCE clinical trial were published by Mahmood K. Razavi, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:921–931). The trial is evaluating adventitial and perivascular drug delivery of dexamethasone to improve primary patency in the treatment of superficial femoral and popliteal artery disease.
DANCE pairs the Bullfrog microinfusion device (Mercator MedSystems, Inc.) with dexamethasone to treat femoropopliteal peripheral artery disease (PAD) adjunctive to standard endovascular revascularization. The prospective, multicenter, single-arm study was designed and sponsored by Mercator MedSystems and is being conducted at 35 centers. The data were first presented in 2017.
The investigators stated that the background of the study is that drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy.
As summarized in JACC: Cardiovascular Interventions, the DANCE trial enrolled 262 patients (283 limbs) with symptomatic PAD (Rutherford class, 2–4) undergoing percutaneous transluminal angioplasty (PTA; n = 124) or atherectomy (ATX; n = 159) in femoropopliteal lesions ≤ 15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all patients. Thirty-day assessments included major adverse limb events (MALEs) and postoperative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford class, and walking impairment questionnaire.
The investigators reported that at 12 months, primary patency rates in the ATX and PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in the ATX and PTA patients were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALEs plus postoperative death events nor 12-month device- or drug-related deaths or MALEs.
Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis and randomized studies are needed to further test this possibility, concluded the investigators in JACC: Cardiovascular Interventions.