More drug-coated balloon (DCB) patients were event-free at six months compared to those treated with plain percutaneous transluminal angioplasty (PTA), according to global randomised trial demonstrating safety of a DCB in below-the-knee (BTK) use.

London, UK, Thursday 18 April 2019 – The Lutonix DCB is safe to use and effective in patients with narrowed or obstructed arteries below the knee – even more complex ones with minor tissue loss, according to data presented at the Charing Cross Symposium 2019 on Thursday, April 18.

The Lutonix drug-coated balloon (DCB) catheter is designed to deliver a therapeutic dose of paclitaxel – an anti-proliferative drug commonly used to prevent the recurrence of narrowed arteries – to the arterial wall in a single, short inflation during treatment for narrowed or obstructed arteries. Amputation rates in this study were low and equal between the treatment arms.

Patrick Geraghty, from the Washington University School of Medicine and co-director of the limb salvage programme at Barnes Jewish Hospital, both in St Louis, Missouri, presented six-month results from the Lutonix BTK Trial. This prospective, multicentre, single-blind, randomised, controlled trial compares the Lutonix DCB to standard balloon angioplasty for the treatment of stenosis or occlusion of below-the-knee arteries in 442 patients.

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

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 six months compared to 70.7% of PTA patients. This improved efficacy was also seen in patients with a Rutherford Classification score of 5 (RC5), describing those experiencing minor tissue loss as a result of chronic limb ischaemia, e.g. a non-healing ulcer or focal gangrene with diffuse pedal ischaemia. Here, 79.4% of DCB patients remained disease-free at six months, compared to 61.6% of PTA patients.

In terms of safety, the two treatments were statistically comparable, with 97.8% of DCB patients surviving at six months (96% in RC5 DCB patients) compared to 95.3% of PTA patients (92.8% in RC5 PTA patients). Presented for the first time, interim 36-month mortality results with over 50% of subjects having completed their 36-month clinical follow-up visit, no difference is seen in all-cause mortality between study arms (26% DCB vs. 29% PTA).

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‘DCB IDE below-the-knee six-month results with in-depth look at Rutherford 5 patients’ will be presented during the Peripheral Arterial Podium 1st session which takes place on 18 April at 10:30–12:30 in the Lower Main Auditorium at Olympia Grand, London, UK.

About the Charing Cross (CX) Symposium The Charing Cross (CX) Symposium is Europe’s largest and longest-running vascular symposium. CX first took place in 1978 at Charing Cross Hospital, Hammersmith, London, and had around 100 attendees. In 2018, the CX Symposium had over 4,000 participants, from 86 countries, making it a leading global vascular meeting. CX 2019 takes place once again at Olympia London from 15–18 April 2019. This year, CX Symposium has lined up a record number of 26 high-impact Podium 1st presentations.
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