Twelve-Month Data Presented From Global Lutonix DCB BTK Registry

February 7, 2018—Michael K.W. Lichtenberg, MD, presented 12-month interim outcomes from the global Lutonix drug-coated balloon (DCB) below-the-knee (BTK) registry study at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.

The prospective, multicenter, single-arm, real-world registry is investigating the clinical use and safety of the Lutonix DCB percutaneous transluminal angioplasty catheter (BD Interventional, formerly Bard Peripheral Vascular) for treatment of stenosis or occlusion of native BTK arteries in a heterogeneous patient population.

The registry inclusion criteria were patients with Rutherford class 3 to 5 and ≥ 70% stenosis lesions with target vessel reconstitution at or above the ankle with inline flow to at least one patent. Exclusion criteria were neurotrophic ulcer, heel pressure ulcer, or ulcer potentially involving the calcaneus in the index limb.

The study's primary safety endpoint was 30-day freedom from BTK major adverse limb events (MALEs) plus perioperative death (POD). The primary efficacy endpoint was 6-month freedom from target lesion revascularization. The study design includes follow-up conducted at 1, 6, 12, and 24 months.

The findings include data on 364 of 371 patients enrolled in the registry (men, 72%; mean age, 73.6 ± 9.5 years; Rutherford class 5, 65.8%) from 29 international centers. The mean total target lesion length was 121 ± 97.9 mm. TASC classifications were: A (25.3%), B (26.2%), C (16.8%), D (14.3%), and unknown (17.4%). Of 349 patients, 68.2% had lesion calcification. Of 295 patients, 24.4% had severe calcification.

In 144 patients available at 12-month follow-up evaluation, the Kaplan-Meier estimate rate of freedom from primary safety events was 92.8% (95% confidence interval [CI], 88.5%–95.6%). The investigators highlighted a 94.8% rate of freedom from amputation at 12 months. The study's primary safety endpoint of MALEs plus POD at 30 days was 98.6% (95% CI, 96.6%–99.4%) in 346 patients.

At 12 months, the Kaplan-Meier estimate freedom from target lesion revascularization rate was 76% (95% CI, 69.2%–81.5%) in 117 patients. For the study's primary efficacy endpoint of 6-month freedom from TLR, the rate was 90.6% (95% CI, 86.4%–93.5%) in 237 patients.

In addition, 110 of 144 (77%) patients had shown improvement by ≥ 1 Rutherford class level and 86 (60%) had improved by ≥ 3 Rutherford class levels at 12 months.

These 12-month data demonstrate that the Lutonix DCB is a promising treatment for BTK arteries with safety outcomes consistent with the device's strong safety profile in peripheral artery disease treatment, concluded Dr. Lichtenberg at LINC 2018.