Data Presented From Mercator MedSystems' DANCE Trial
February 8, 2017—Mercator MedSystems, Inc. announced that the National Coprincipal Investigators of the company's DANCE trial recently presented comprehensive 13-month data. Mahmood Razavi, MD, presented the data during late-breaking sessions at ISET 2017, the International Symposium on Endovascular Therapy in Hollywood, Florida. George Adams, MD, presented the data at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.
DANCE is a perivascular drug delivery trial that pairs the Bullfrog microinfusion device (Mercator MedSystems, Inc.) with dexamethasone to treat femoral and popliteal arteries after revascularization. The prospective, multicenter, single-arm study was designed and sponsored by Mercator MedSystems and is being conducted at 35 centers.
The Bullfrog microinfusion device was used in the trial to deliver a generic anti-inflammatory steroid (dexamethasone) along with radiopaque contrast to visualize distribution. The drug was delivered to the tissues around the femoropopliteal arteries after endovascular intervention to forcibly open obstructions. The data demonstrate a high level of revascularization durability, low occurrence of major adverse limb events, and no device- or drug-related adverse events, stated the company.
In the announcement, Dr. Razavi commented, "We attribute the success seen in the DANCE trial to the Bullfrog device and its ability to efficiently deliver drug in difficult-to-reach anatomy." Dr. Razavi continued, "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."
According to the company, the 13-month data from DANCE were separated into two groups based on the method of revascularization: atherectomy was performed in 157 limbs, and angioplasty without atherectomy was performed in 124 limbs. For both groups, the primary safety endpoint revealed no postoperative deaths within 30 days, with the rate of major adverse limb events before revascularization reported as 1.6% in the atherectomy group and 0.9% in the angioplasty group.
The per-protocol primary efficacy endpoint of primary patency did not widely vary between groups, with 83.6% at 12 months and 80.0% at 13 months in the atherectomy group and 80.2% at 12 months and 78.2% at 13 months in the angioplasty group.
Primary patency was defined as the lack of clinically driven target lesion revascularization (CD-TLR) or narrowing detected by a duplex ultrasound peak systolic velocity ratio > 2.4. Freedom from CD-TLR was 89.6% at 12 months and 88.7% at 13 months in the atherectomy group and was 89.1% at both 12 and 13 months in the angioplasty group.
No broad disparities were reported among results by sex, with a 13-month primary patency rate of 79.3% in men and 77.9% in women, or by diabetic status, with a 13-month primary patency rate of 79.5% in patients with diabetes versus 78.8% in patients without diabetes.
The company advised that the Bullfrog microinfusion device has received US Food and Drug Administration 510(k) clearance and European CE Mark approval. The system is designed to infuse therapeutic and diagnostic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues.