Author + information
- 1St. Joseph Cardiac and Vascular Center, Orange, California, United States
- 2Massachusetts General Hospital, Boston, Massachusetts, United States
- 3Independent Consultant, Durham, North Carolina, United States
- 4Wake Forest, Winston-Salem, North Carolina, United States
- 5UNC REX HEALTHCARE, Raleigh, North Carolina, United States
Drug-coated balloons (DCB) and drug eluting stents (DES) improve patency of endovascular interventions by the passive diffusion of drugs that target down-stream responses to vessel injury, like cellular proliferation. Direct adventitial drug delivery may be a potent anti-restenotic strategy by instead targeting the initial triggers of the inflammatory reaction to injury. This study was designed to evaluate the outcomes of direct adventitial delivery of dexamethasone as an adjunct to mechanical revascularization in femoropopliteal obstructive atherosclerotic disease.
The DANCE trial enrolled 283 limbs in subjects with symptomatic PAD and Rutherford scores of 2-4 at baseline who had received primary angioplasty (PTA, N=124) or atherectomy (ATX, N=159) in femoropopliteal lesions up to 15 cm in length. A mix of dexamethasone (80%) and contrast medium (20%) were delivered to the adventitia and perivascular tissue around target lesions at a target dosage of 1.6 mg dexamethasone (0.5 mL) per centimeter of lesion length in all enrolled subjects. The 30-day assessments included major adverse limb events and post-operative death (MALE+POD), and 12-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring and a walking impairment questionnaire. Primary statistical analysis compared the primary patency rates to historical PTA and DCB treatments from pivotal IDE trials, with similar eligibility criteria to the DANCE study.
At 12 months, primary patency in DANCE-ATX and -PTA subjects were 74.8% (78.4% per protocol, PP) and 74.3% (75.5% PP), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 13.1% (10.0% PP) and 13.7% (11.0% PP), respectively. There were no 30-day MALE+POD events nor device- or drug-related deaths or major adverse limb events through one year in either group. DANCE patency rates were superior to historical PTA patency rates of 52.5% (p=<0.001 for ATX and PTA groups) and non-inferior to DCB patency rates of 72.3% (p=<0.001 for ATX and p<0.004 for PTA).
Direct adventitial delivery of dexamethasone is an effective and safe therapy to prevent restenosis, demonstrating patency rates similar to paclitaxel-coated balloons and superior to historical PTA treatment.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery