Paclitaxel-coated balloons demonstrated favorable functional and clinical outcomes in patients with long femoropopliteal artery disease requiring percutaneous revascularization, according to results from the SFA-Long (Drug Eluting Balloon and Long Lesions of Superficial Femoral Artery Ischemic Vascular Disease) study.
Previous trials that have evaluated paclitaxel-coated balloons included only simple and short lesions. Therefore, SFA-Long investigators enrolled patients whose mean lesion length was 251 ± 71 mm, including moderate to severely calcified lesions (63.4%) and total occlusions (49.5%).
Findings were published in JACC: Cardiovascular Interventions.
The primary end point was primary patency at 12 months. Secondary end points included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months after percutaneous transluminal angioplasty (PTA).
A total of 105 patients (mean age: 68 ± 9 years; 81.9% men) were treated with paclitaxel-coated balloons. Prior to study enrollment, patients who were not taking aspirin and clopidogrel received loading doses of aspirin (300 mg) and clopidogrel (300 mg) 12 hours before PTA. After the procedure, all patients received 100 mg/d aspirin indefinitely and 75 mg/d clopidogrel for 12 weeks (or 6 months in the case of stenting). They also received a bolus dose of 5000 IU heparin after sheath insertion in the common femoral artery.
The mean lesion reference vessel diameter was 5.1 ± 0.5 mm and the diameter stenosis, as measured via visual estimation by an independent operator, was 93.7% ± 8.4%. Bailout stenting was used in 11 lesions.
Technical success was achieved in 97.1% of patients. At 12 months, the primary patency was 89.3% and at 390 days the patency was 86.1% by Kaplan-Meier estimate. Occlusive and stenotic lesions were also compared for patency (88.4% vs 91.5% at 360 days) with no statistically significant difference (log-rank P=.1649). Clinically driven target lesion revascularization rate was 4%. Rutherford class 0 (asymptomatic patients) increased from 0% at baseline to 58% at 12 months.
In addition, no major amputations or procedure- or device-related deaths were reported through 12 months. Quality of life significantly improved (via the EQ-5D assessment), ankle-brachial index was significantly higher (0.63 vs 0.95; P<.001), and walking impairment improved (P=.01).
“Despite its established limitations, PTA with or without stenting is widely used at many centers,” researchers noted. “Self-expandable bare-metal stents have recently shown to be beneficial in comparison with standard PTA, especially when new-generation devices are used for relatively simple lesions. However, the inherent benefits of such permanent prostheses over PTA alone have not convinced all operators to use them in a routine fashion, especially for long lesions for which placement of full metal jackets is not considered the standard of care.”
They added that restenosis in long SFA lesions following stenting has been reported to occur up to 50%, and the pattern of restenosis in full metal jackets is “diffuse” in-stent restenosis or in-stent occlusions, which makes treatment difficult.
However, the results of the present study demonstrate the possibility of favorable outcomes in a long lesion patient population, which may be attributed to the operators’ ability to limit stenting. Indeed, the bailout stent rate was 10.9%, which is much lower than previously reported.
“The use of PCBs [paclitaxel-coated balloons] in treating complex long lesions is new and potentially revolutionary,” researchers concluded. “Larger registries and randomized studies comparing PCBs with PTA or stenting are needed to confirm the outcomes reported here.”
Micari A, Vadalà G, Castriota F, et al. 1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease. Evidence from the SFA-Long study. JACC Cardiovasc Interv. 2016;9(9):950-956. doi: 10.1016/j.jcin.2016.02.014.