Author + information
- Received July 13, 2017
- Revision received November 28, 2017
- Accepted December 5, 2017
- Published online May 2, 2018.
- Mahmood K. Razavi, MDa,∗ (, )
- Dennis Donohoe, MDb,
- Ralph B. D’Agostino Jr., PhDc,
- Michael R. Jaff, DOd,
- George Adams, MDe,
- on behalf of the DANCE Investigators
- aSt. Joseph Heart and Vascular Institute, Orange, California
- bIndependent consultant, Durham, North Carolina
- cWake Forest University School of Medicine, Winston-Salem, North Carolina
- dHarvard Medical School, Boston, Massachusetts
- eUniversity of North Carolina, Rex Hospital, Raleigh, North Carolina
- ↵∗Address for correspondence:
Dr. Mahmood K. Razavi, St. Joseph Heart and Vascular Institute, 1100 West Stewart Avenue, Orange, California 92868.
Objectives This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease.
Background 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.
Methods The single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving 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 subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire.
Results At 12 months, primary patency rates in DANCE-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 DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE.
Conclusions Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)
The study was funded by Mercator MedSystems, Inc. Dr. Razavi has been a consultant for Abbott Vascular, Biomet/Zimmer, Mercator MedSystems, Spectranetics, Medtronic, Microvention/Terumo, Veniti, and Boston Scientific. Dr. Donohoe has been a clinical and regulatory consultant to Mercator MedSystems; and is a clinical consultant for C.R. Bard. Dr. D’Agostino has been a consultant for Mercator MedSystems, Edwards Lifesciences, Sanofi, Coherus, Puma Pharmaceuticals, and RedHill Biopharma; and has been on the data safety monitoring boards for Medtronic. Dr. Jaff has been an unpaid advisor to Abbott Vascular, Boston Scientific, Cordis, and Medtronic; has been a consultant to Philips Volcano and Venarum; and has equity ownership in PQ Bypass, Vascular Therapies, and EFemoral. Dr. Adams has been a clinical consultant for Mercator MedSystems, Cook Medical, Spectranetics, C.R. Bard, Boston Scientific, Cardiovascular Systems, Inc., and Medtronic.
- Received July 13, 2017.
- Revision received November 28, 2017.
- Accepted December 5, 2017.
- 2018 American College of Cardiology Foundation
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