October 23, 2012 — The use of stents for arterial blockages in the leg has been associated with high rates of late restenosis, or re-narrowing of the affected region. In the DEBATE-SFA trial, researchers found that the use of a paclitaxel drug-eluting balloon (DEB) to widen the artery prior to implanting a self-expanding nitinol stent yielded a lower restenosis rate after one year. Results of the trial were presented Monday at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).
The DEBATE-SFA trial is a prospective, randomized, open-label trial. Between September 2009 and June 2011, researchers enrolled 104 patients with 110 lesions located in the superficial femoral (SFA) or popliteal arteries. Patients in the study underwent peripheral revascularization for intermittent claudication (pain caused by poor blood flow during exercise) or critical limb ischemia (severe obstruction of the arteries that seriously decreases blood flow to the extremities with consequent tissue loss and rest pain). Fifty-three patients (55 lesions) received the DEB and a nitinol stent, while 51 patients (55 lesions) received conventional therapy (balloon angioplasty and nitinol stent). Binary restenosis at one year, either by angiography or ultrasonographic evaluation, was the primary endpoint. Clinically driven in-segment target lesion revascularization (TLR) was a key secondary endpoint.
Binary restenosis was diagnosed in 43 percent of the lesions in the conventional group and 17 percent of the lesions in the DEB group (p=0.001), while TLR occurred in 33 percent of the lesions in the conventional group compared to 16 percent of the lesions in the DEB group (p=0.07).
“The use of a paclitaxel-eluting balloon prior to stenting significantly reduces one year restenosis rates and target lesion revascularization in interventions of the superficial femoral or popliteal arteries,” said lead investigator, Francesco Liistro, M.D.. from San Donato Hospital in Arezzo, Italy. “We believe this study has important implications for patients with blockages in the arteries of the leg.”
For more information: www.crf.org