LEVANT 2, RIBS Show Promise for Paclitaxel-Coated Balloons in PAD and CAD

San Francisco, CA—Data from two trials presented Wednesday at TCT 2013 show encouraging results for paclitaxel-coated balloons in patients with either femoropopliteal artery disease or bare-metal stent (BMS) in-stent restenosis. 

Kenneth Rosenfield, MD, of Massachusetts General Hospital, presented 6-month findings from the multicenter, randomized controlled LEVANT 2 trial comparing an investigational paclitaxel-coated balloon (Lutonix-Bard) with standard balloon angioplasty for the treatment of femoropopliteal artery lesions in 476 patients across 55 global sites. All patients were unlikely to require a stent based on strict angiographic criteria.

At 183 days, the primary patency of the treated vessel was higher among those treated with the drug-coated balloon (DCB) compared with patients treated with standard balloon angioplasty (92.3% vs. 82.7%), driven by lower rates of binary restenosis with the DCB (17.4% vs. 33.8%; P<.001). The primary safety endpoint — a composite of freedom from peri-operative death and freedom at 1 year in the index limb from amputation, re-intervention and index–limb-related death — were similar between the DCB and the standard balloon (94% vs. 94.1%).

“LEVANT 2 is a unique study in many ways,” Rosenfield said. “Unlike other drug-coated balloon studies, this study was specifically designed to eliminate potential confounding factors that could lead to bias. The strategy of control pre-dilatation prior to randomization was effective in eliminating the need for stenting.”  

DEB similar to EES  

During another presentation, Fernando Alfonso, MD, PhD, of Hospital Universitario de la Princesa in Madrid, Spain, presented data from the multicenter, prospective, randomized RIBS V clinical trial. Researchers randomly assigned 189 patients with BMS in-stent restenosis to receive either an everolimus-eluting stent (EES; Xience Prime, Abbott Vascular; n=86) or a paclitaxel-coated balloon (SeQuent Please, B. Braun Surgical; n=84).  

At 1 year follow-up, minimal lumen diameter was greater in the EES group vs. the DCB group (2.36 mm  vs. 2.01 mm; P<.001), as was minimal lumen diameter (2.44 mm vs. 2.03 mm; P<.001). Additionally, EES was superior to DCB for percent diameter stenosis (see Figure).  However, restenosis and late loss were low and similar in both groups. 

 “In patients with BMS in-stent restenosis, both DEB and EES provided excellent long-term clinical outcomes,” Alfonso said. “However, EES provide superior late angiographic results, including minimal lumen diameter and percent diameter stenosis. Further studies are required to elucidate if these superior late angiographic findings eventually translate into a clinical benefit.”  

 Disclosures:

Alfonso reports no relevant conflicts of interest. 

Rosenfield reports receiving consultant fees from Abbott Vascular; equity in Primacea; research support from Abbott Vascular, Atrium, IDEV and Lutonix-Bard; and is a board member of VIVA Physicians.