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May 2, 2019

Safety and Efficacy Data Presented for BD's Lutonix DCB in Below-the-Knee Arteries

May 1, 2019—Patrick Geraghty, MD, presented 6-month results from the Lutonix BTK trial at the 2019 Charing Cross Symposium, held April 15–18 in London, United Kingdom. The prospective, multicenter, single-blind, randomized controlled trial comparing the Lutonix drug-coated balloon (DCB; BD [Becton, Dickinson and Company]) to standard percutaneous transluminal angioplasty (PTA) for the treatment of stenosis or occlusion of below-the-knee (BTK) arteries in 442 patients.

Additionally, interim 36-month mortality results for the Lutonix device were presented for the first time at Charing Cross. With more than 50% of patients having completed their 36-month clinical follow-up visit, no difference was seen in all-cause mortality between the DCB and PTA study arms (26% versus 29%).

As reported in the Charing Cross Symposium press release, the 6-month data demonstrated the safety and efficacy of the paclitaxel-coated Lutonix DCB in patients with narrowed or obstructed BTK arteries—including more complex vessels—with minor tissue loss. Amputation rates in this study were low and equal between the treatment arms.

The study's primary safety endpoint was a composite of all-cause death, above-ankle amputation, or major reintervention within 30 days of the procedure. The primary efficacy endpoint was assessed by freedom from the composite of above-ankle amputation, target vessel occlusion and clinically driven target lesion revascularization (primary patency) at 6 months.

According to the Charing Cross Symposium, Dr. Geraghty reported that treatment with the Lutonix DCB resulted in a 14.6% improvement in efficacy compared to conventional treatment with PTA, with 85.3% of DCB patients remaining event-free at 6 months compared to 70.7% of PTA patients. This improved efficacy was also seen in patients with Rutherford class 5 disease experiencing minor tissue loss as a result of chronic limb ischemia. In these DCB patients, 79.4% remained disease-free at 6 months compared to 61.6% of PTA patients.

The investigators found that the two treatments were statistically comparable regarding safety, with 97.8% of DCB patients surviving at 6 months (96% in Rutherford class 5 DCB patients) compared to 95.3% of PTA patients (92.8% in Rutherford class 5 PTA patients), stated the Charing Cross announcement.

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May 2, 2019

FDA Advises of Increased Adverse Outcomes With Off-Label Use of Stryker's Wingspan

May 2, 2019

FDA Advises of Increased Adverse Outcomes With Off-Label Use of Stryker's Wingspan