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Localized drug delivery with micro-infusion device yields positive outcomes in PAD

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HOLLYWOOD, Fla. — Use of a micro-infusion device to deliver dexamethasone to the tissues around femoropopliteal arteries along with radio-opaque contrast to visualize distribution yielded positive outcomes at 13 months in patients with peripheral artery disease undergoing endovascular intervention.

Mahmood Razavi, MD, FSIR, FSVM, medical director of the Comprehensive Aortic Center and clinical trials department at St. Joseph Heart and Vascular Institute, Orange, California, presented 13-month data from the DANCE trial at the International Symposium on Endovascular Therapy demonstrating a high level of durability, low occurrence of major adverse limb events, and no device- or drug-related adverse events.

The prospective, multicenter, single-arm trial 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 2-4 and de novo or restenotic lesions in the superficial femoral or femoropopliteal arteries. The study focused on two different revascularization options: atherectomy (n = 157) and percutaneous transluminal angioplasty (n = 124). The mean age of patients was 68 years, most were men and there was a higher inclusion of black participants than in other trials. The population was very similar to that included in critical limb ischemia trials, he noted.

In both groups, the primary safety endpoint revealed no postoperative death within 30 days, with major adverse limb events prior to revascularization reports at 1.6% in the atherectomy group and 0.9% in the angioplasty group.

The per-protocol primary efficacy endpoint — primary patency of the target lesion — was 83.6% at 12 months and 80% at 13 months in the atherectomy group and 80.2% at 12 months and 78.2% at 13 months in the angioplasty group. Freedom from clinically driven target lesion revascularization was 89.6% at 12 months and 88.7% at 13 months in the atherectomy group and 89.1% at 12 and 13 months in the angioplasty group.

Outcomes did not differ by sex, as 13-month patency was 79.3% in men and 77.9% in women. There was also no difference in 13-month primary patency outcomes by diabetes status: diabetes, 79.5%; no diabetes, 78.8%. In addition, the difference in 13-month patency outcomes was minor between stented (79.7%) and unstented (76.3%) patients in the angioplasty group.

“The [adventitial delivery of dexamethasone] procedure in DANCE has produced positive results in both primary atherectomy, in a challenging patient population, and primary angioplasty intervention,” Razavi said.

He noted that several other trials evaluating adventitial drug delivery are ongoing or in planning stages, including:

• LIMBO-PTA: adventitial drug delivery of dexamethasone below the knee with angioplasty; target enrollment: 120
• LIMBO-ATX: adventitial drug delivery of dexamethasone below the knee with atherectomy: target enrollment: 120
• PRT-201-115 (Proteon): adventitial drug delivery of vonapanitase (elastase) below the knee; target enrollment: 40
• TANGO: adventitial drug delivery of limus below the knee; target enrollment: 60
• TWIST: adventitial drug delivery of combination therapy; in planning stages.

The Mercator Bullfrog Micro-Infusion Device has FDA 510(k) clearance and a CE Mark. The device is tipped with a balloon-sheathed microneedle, and is compatible with 0.014-in guidewires and 5F to 7F introducer sheaths. The closed balloon provides a protective covering for a perpendicular-oriented injection needle as it is guided through the vasculature to target vessels with diameters of 2 to 8 mm, according to a press release from Mercator MedSystems.

“Technologies such as drug-coated balloons or drug-eluting stents use chemotherapeutic agents to reduce the risk of scar tissue buildup inside the arteries. Alternatively, we have proposed that the delivery of an anti-inflammatory agent to the outside of the artery enhances the healing process and interrupts the cascade leading to scar formation and restenosis. Overall, we have found the therapy in DANCE to be intuitive, safe and effective,” Razavi said in the release. – by Katie Kalvaitis

Reference:

Razavi M. Concurrent Session VI: Late-Breaking Trials and Hot Topics. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure: The study was funded by Mercator MedSystems. Razavi reports receiving advisory or speaking fees from Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Medtronic, Mercator MedSystems, Microvention/Terumo, Neuravi, Penumbra, Reflow Medical, Soundbite Medical, Veniti and Walk Vascular, and research support through ongoing trials from Bard Peripheral Vascular, Boston Scientific, Intact Vascular, Mercator, the NIH, Spectranetics and Veniti.