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Localized dexamethasone infusion beneficial in PAD at 24 months
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SAN DIEGO — Localized drug delivery with a micro-infusion device was effective at 24 months in patients with peripheral artery disease undergoing primary atherectomy or primary angioplasty, according to findings presented at TCT 2018.
As Cardiology Today’s Intervention previously reported, the prospective, multicenter DANCE study was designed to assess localized delivery of dexamethasone into the adventitial and perivascular tissues via the Bullfrog Micro-Infusion Device (Mercator MedSystems). Researchers enrolled 281 patients with Rutherford class 2 to 4 and de novo or restenotic lesions in the superficial femoral or femoropopliteal arteries. Among the cohort, 157 patients underwent primary atherectomy (mean age, 68 years; 57% men) and 124 underwent primary percutaneous transluminal angioplasty (mean age, 69 years; 65% men).
Ehrin J. Armstrong, MD, MSc, FSCAI, director of the VA Eastern Colorado Healthcare System and associate professor of medicine at University of Colorado School of Medicine, presented 24-month results here.
“Dexamethasone is a ubiquitous and commonly used anti-inflammatory drug with both local and systemic effect,” Armstrong said during a presentation. “It reduces inflammatory signaling and proliferation and protects cells from necrosis and apoptosis, which could otherwise lead to later-stage proliferative responses.”
At 24 months, 13.2% of patients in the atherectomy arm died, as did 7.8% of patients in the angioplasty arm. The rates of 24-month death from a CV or unknown cause were 8.5% in the atherectomy arm and 4.9% in the angioplasty arm, Armstrong said.
Primary patency at 24 months occurred in 72.2% of the atherectomy arm and 68.9% of the angioplasty arm, whereas 24-month rates of freedom from clinically driven target lesion revascularization were 86.1% in the atherectomy arm and 83.7% in the angioplasty arm, according to the researchers.
“At 2 years after adventitial dexamethasone treatment, stents did not appear to have a large effect on patency, particularly in the angioplasty study; there was no significant gender disparity in patency rates; diabetics tended to do as well or better than nondiabetics, particularly in the angioplasty study; the popliteal region, where patency is not typically as durable, appears to benefit, especially with atherectomy; and severe calcification appears to have particular benefit with the addition of dexamethasone,” Armstrong said during the presentation.
There are several compelling reasons why clinicians might use adventitial dexamethasone delivery with atherectomy instead of a drug-coated balloon, he said.
“There are limited atherectomy plus DCB data outside of the DANCE trial; actually, there are no data with a currently available DCB in the U.S.,” Armstrong said. “In an era when DCB is not separately reimbursed, Bullfrog Micro-Infusion offers an ability to use one device to treat long lesions, rather than multiple devices.” – by Erik Swain
Reference:
Armstrong EJ, et al. Keynote Interventional Studies I: Endovascular Interventions. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: The study was funded by Mercator MedSystems. Armstrong reports no relevant financial disclosures.