Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial
Background—Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) with regard to restenosis prevention for de-novo superficial femoral artery (SFA) disease. For in-stent restenosis (ISR), the benefit of DCBA over POBA remains uncertain.
Methods and Results—One-hundred-nineteen patients with SFA ISR and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n = 62) or POBA (n = 57). Mean lesion length was 82.2 ± 68.4 mm. Thirty four (28.6%) lesions were totally occluded, 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary endpoint of recurrent ISR assessed by ultrasound at 6 months was 15.4% (8/52) in the DCBA and 44.7% (21/47) in the POBA group (P = 0.002). Freedom from target lesion revascularization (TLR) was 96.4 % vs. 81.0% (P = 0.0117) at 6 months and 90.8% vs. 52.6% (P < 0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥ 1 Rutherford category without the need of TLR was observed in 35/45 DCBA patients (77.8%) and 23/44 POBA patients (52.3%, P = 0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure-related.
Conclusions—DCBA for SFA ISR is associated with less recurrent restenosis and a better clinical outcome than POBA, without an apparent difference in safety.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT01305070.
- superficial femoral artery
- in-stent restenosis
- drug-eluting balloon
- peripheral artery disease
- randomized controlled trial
- Received May 7, 2015.
- Revision received August 26, 2015.
- Accepted September 10, 2015.