FDA Pivotal Trial Examines Safety, Efficacy of Drug-Coated Balloon Angioplasty
November 1, 2013
November 1, 2013 — The first clinical trial in the United States to study the use of drug-coated balloons (DCB) for femoropopliteal artery disease found the procedure is promising for safety and efficacy at six months. Six-month data of the LEVANT 2 trial was presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
The trial examined the C. R. Bard Inc. Lutonix drug-coated balloon. 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 randomized 476 patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outlflow artery to the foot. After a successful protocol-defined pre-dilation, subjects unlikely to require a stent based on strict angiographic criteria were randomized two-to-one to the treatment with either a drug-coated balloon (DCB) or PTA alone with a standard balloon.
At six months by Kaplan-Meier time-to-event analysis, primary patency of the treated vessel was higher among patients treated with a DCB (92.3 percent versus 82.7 percent). Patients treated with DCB experienced similar freedom from major adverse events compared to the PTA group (94 percent in the DCB group and 94.1 percent in the PTA group). Repeat revascularization rates at this interim time point were low and consistent in both groups.
“During angioplasty, DCBs are designed to deliver an anti-proliferative 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 Kenneth Rosenfield, M.D., section head, vascular medicine and intervention, chairman, STEMI and Acute MI Quality Improvement Committee, Massachusetts General Hospital and co-primary investigator of the study. “These findings are an important step toward making this novel treatment available to patients in the United States.”
Bard acquired Lutonix Inc. in December 2011. The Lutonix drug-coated balloon received European CE mark approval in 2011. The device is not commercially available in the United States and is limited to IDE use.
The LEVANT 2 trial was funded by C.R. Bard and Lutonix. Rosenfield reported being a consultant for Abbott Vascular; equity in Primacea; research or fellowship support from Abbott Vascular, Atrium, Lutonix-C.R. Bard, and IDEV; board member of VIVA Physicians.
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