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Paclitaxel-coated balloons yield favorable outcomes for femoropopliteal artery disease
Patients with long, complex lesions in the femoropopliteal artery exhibited high rates of primary patency at 12 months with few major adverse events after percutaneous revascularization with a paclitaxel-coated balloon, according to results from the SFA-LONG study.
Researchers evaluated 105 adult patients (mean age, 68 years; 81.9% men) with long femoropopliteal artery disease of class 2 to 4. Patients underwent percutaneous transluminal angioplasty with paclitaxel-coated balloons (In.Pact Admiral, Medtronic) and provisional stenting between September 2012 and May 2014 at six facilities throughout Italy. All patients had lesions longer than 15 cm (mean, 251 mm) and reference vessel diameter between 4 mm and 7 mm (mean, 5.1 mm). Treated lesions were moderately to severely calcified in 63.4% of cases, and 49.5% were total occlusions.
The primary endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization, occlusion or restenosis greater than 50%. Secondary endpoints included a composite of major adverse events, including death, major amputation of the target limb, thrombosis at the lesion site, or nontarget lesion target vessel revascularization; and changes to Rutherford class, ankle-brachial index or quality of life up to 24 months after treatment.
Technical success, defined as successful access and device deployment and completion of the procedure with less than 30% residual stenosis, occurred in 97.1% of patients. Bailout stenting was required in 10.9% of patients.
Among 101 patients with evaluable follow-up data, 83.2% maintained primary patency, 96% were free from TLR and 84.2% were free of restenosis greater than 50% at 12 months. The patency rate was 88.4% among patients with occlusive lesions at 12 months vs. 91.5% among those with stenotic lesions (P = .1649). TLR occurred in 4% of patients.
Researchers observed significant and persistent improvements to Rutherford class upon completion of follow-up, with the proportion of asymptomatic patients (class 0) increasing from 0% at baseline to 58% at 12 months. Seven patients experienced major adverse events, including four deaths, none of which were attributed to the device or procedure; one case of thrombosis and two cases of TVR of a nontarget lesion. No patients required major amputation.
Quality of life, as indicated by responses to the EuroQol-5 dimensions questionnaire (EQ-5D), improved at 12 months, and patients exhibited less walking impairment (P = .01). The researchers also observed an increase to ankle-brachial index at 12 months (0.95 vs. 0.63 at baseline; P < .001).
“This Italian registry presents valuable information on outcomes in very long and occluded lesions with the use of [paclitaxel-coated balloons],” the researchers concluded. “The consistency of the results from this more complex lesion set with those reported in randomized controlled trials provides some reassurance to physicians considering the use of [paclitaxel-coated balloons] of good clinical outcomes.” – by Adam Taliercio
Disclosure: One researcher reports serving as a consultant for Medtronic, which provided funding for the study.