LEVANT 2, the first clinical trial in the USA to study the use of drug-coated balloons (CR Bard’s Lutonix) for femoropopliteal artery disease, found the procedure is promising for safety and efficacy at six months.
At six months by Kaplan-Meier time-to-event analysis, primary patency of the treated vessel was higher among patients treated with a drug-coated balloon (92.3% vs. 82.7%, p=0.003). Patients treated with drug-coated balloons experienced similar freedom from major adverse events compared to the angioplasty group (94% in the drug-coated balloons group and 94.1% in the angioplasty group). Repeat revascularisation rates at this interim time point were low and consistent among both groups.
Six month data of the LEVANT 2 trial was presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (27 October–1 November, San Francisco, USA).
There are a number of minimally invasive therapies used to treat femoropopliteal disease, including standard percutaneous transluminal angioplasty, stents (both drug-eluting and bare metal), and atherectomy devices. Unfortunately, restenosis rates in the femoropopliteal arteries remain high due to the length and complexity of disease.
The primary safety endpoint was composite freedom from all-cause perioperative death and freedom at one year in the index limb from amputation, re-intervention, and index-limb-related death. The primary efficacy endpoints were primary patency of the target lesion at one year and absence of restenosis.
LEVANT 2 is a prospective, multicentre, single-blind, trial that randomised 476 patients presenting with claudication or ischaemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After a successful protocol-defined pre-dilation, subjects unlikely to require a stent based on strict angiographic criteria were randomised 2:1 to the treatment with either a drug-coated balloon or percutaneous transluminal angioplasty alone with a standard balloon.
“During angioplasty, drug-coated balloons are designed to deliver an antiproliferative drug directly to the tissues of the treated vessel wall, thus inhibiting neointimal hyperplasia and restenosis without the need for a permanent foreign body implant,” said co-primary investigator, Kenneth Rosenfield. Rosenfield is section head, Vascular Medicine and Intervention and chairman, STEMI and Acute MI Quality Improvement Committee at Massachusetts General Hospital, Boston, USA.
Rosenfield told delegates that LEVANT 2 was a rigorous trial designed to reduce bias. There was controlled pre-dilatation prior to randomisation to limit the number of bailout stents and the trial did not count bail-out stenting as target lesion revascularisation, he said.