WASHINGTON — Among patients with critical limb ischemia, the use of percutaneous catheter-delivered ultrasound and paclitaxel offers ease of use and efficacy in treating all lesion lengths and vessel sizes at any location, according to findings from the PACUS trial presented at TCT 2016.
In the prospective, randomized, double-arm, single-center clinical trial, researchers evaluated 56 patients with CLI assessed between November 2013 and February 2015. Eligible participants met the following criteria: age 18 years or older; Rutherford class 4 to 6; CLI associated with femoropopliteal lesions; symptomatic long segmental stenosis, chronic total occlusions or severe calcifications; successful intraluminal recanalization to obtain a satisfactory angiographic result; and at least one patent below-the-knee vessel.
Patients were randomly allocated at a 1:1 ratio to treatment with ultrasound followed by local delivery of paclitaxel (Genesis system, CardioProlific; study group; n = 28) or to treatment with a drug-eluting balloon (IN.PACT Admiral, Medtronic; control group; n = 28). Five patients (two in the study group) died before 12 months; the rest were available for 12-month follow-up.
Costantino Del Giudice, MD, from Hôpital Européen Georges Pompidou, Université Paris Descartes, and colleagues found that, at 1-month follow-up, there was a 100% rate of technical success in both groups and no restenosis in either group.
Angiographic follow-up at 6 months revealed a 3.6% rate of restenosis in the study group vs. 36% in the control group (P = .04). Target lesion revascularization at 6 months was 0% in the study group vs. 10.7% in the control group (P = .08).
At 12-month follow-up, TLR was lower in the study group (3.8% vs. 36%; P = .004); clinical improvement was higher in the study group (92.3% vs. 68%; P = .03); there were no procedure-related deaths in either group; non-procedure-related death was similar (study group, 7.1%; control group, 10.7%; P = .64); and there were fewer amputations in the study group (0% vs. 16%; P = .03).
“The Genesis system is easy to use and capable to treat any lesion length and vessel size at any locations with one device,” Del Giudice said during a presentation. “Encouraging results in CLI cases demonstrate great potential for this technology in the entire [peripheral artery disease]. A larger clinical study is required to validate this promising new therapy.” – by Jennifer Byrne
Del Giudice C, et al. Session II. Peripheral Vascular Disease Technologies 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.
Disclosure: Del Giudice reports receiving grant/research support from Medtronic and Teleflex, and consultant fees from Boston Scientific and Spectranetics.