Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Abstract

Conclusion: Drug-coated balloon angioplasty (DCBA) for superficial femoral artery (SFA) in-stent restenosis (ISR) is associated with less recurrent restenosis and a better clinical outcome than plain old balloon angioplasty (POBA) with no apparent differences in safety. Summary: Treatment of femoropopliteal artery stenotic and occlusive lesions has become main stream in recent years. However, many times long term primary patency rates are suboptimal and as a result treatment of ISR has become increasingly important. For ISR the benefit of treatment with percutaneous techniques using DCBA or POBA remains uncertain. The authors recruited 119 patients with SFA IRS and chronic ischemia over a period of 34 months from five German clinical sites. Patients were randomized to either DCBA (n ¼ 62) or POBA (n ¼ 57). Mean lesion length was 82.2 6 68.4 mm, 28.6% (n ¼ 34) lesions were occluded; 30 (25.2%) were mildly or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point was recurrent IRS assessed by ultrasound at 6 months and was 15.4% in the DCBA group, and 44.7% in the POBA group (P ¼ .002). Freedom from target lesion vascularization was 96.4% vs 81.0% (P ¼ .001117) at 6 months and 90.8% vs 52.6% (P < .0001) at 12 months respectively. At 12 months clinical improvement by $1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P ¼ .015). There were no major amputations performed. Two patients in the DCBA and three patients in the POBA group died. No death was procedure related. Comment: The study is among the first to systematically examine treatment of SFA medium length IRS lesions with DCBA and that it is associated with lower recurrent ISR and target lesion revascularizations at 6 and 12 months than POBA. If angioplasty with drug coated balloons is superior to POBA, and it appears that it is from multiple studies, there is no reason to be surprised by this current study results given that there is no substantial evidence that recurrent restenosis is any different biochemically than primary restenosis. However, it is still too soon to relegate POBA to a procedure of the past. Cost effectiveness trials and trials of meaningful clinical importance such as limb salvage and quality of life benefit still need to be performed in regard to treatment of ISR using POBA vs DCBA.

ISAR‐PEBIS (Paclitaxel‐Eluting Balloon Versus Conventional Balloon Angioplasty for In‐Stent Restenosis of Superficial Femoral Artery): A Randomized Trial

“…Notably, 2 randomized trials comparing 2 different PEB technologies versus BA for ISR of SFA led to inconsistent results. The FAIR (Femoral Artery In‐Stent Restenosis) trial showed a reduction in recurrent restenosis assessed by ultrasound at 6 months and lower risk of TLR at 1 year after a percutaneous therapy with PEB versus BA . In contrast, the PACUBA I (Paclitaxel Balloon Versus Standard Balloon in In‐Stent Restenoses of the Superficial Femoral Artery) trial showed improved primary patency rates but no benefit in terms of TLR at 1 year after a percutaneous therapy with PEB versus BA .…”

SCAI appropriate use criteria for peripheral arterial interventions: An update

“…The treatment of femoral‐popliteal in‐stent restenosis (ISR) is exceptionally challenging due to high rates of reoccurrence. The Femoral Artery In‐Stent Restenosis (FAIR) trial randomized 119 patients with femoral‐popliteal ISR to either DCB ( n = 62) or PTA ( n = 57). These lesions were short to intermediate in length (mean lesion length was 82.2 ± 68.4 mm) with nearly 30% being occlusions and another 25% with moderate to severe vessel calcification.…”

JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries

“…Patency with DCBs ranged from 70.5% to 92.1% with TLR from 9.2% to 13.6% at 1 year. 3,4,28 Also in intermediate lesions, DES using the Zilver PTX showed patency and TLR rates of 95% and 3.8%, respectively, at 6 months and 78.8% and 19% at 1 year. 29 Combining therapeutic modalities may offer a superior treatment than either device can achieve alone.…”

“…21 Treatment of FP ISR with conventional balloon angioplasty carries a higher rate of TLR at 1 year (31% to 47%) and reduced patency rates ranging from 28% to 37%. [1][2][3][4][5] Chronic total occlusion is a strong predictor of loss of patency and a higher TLR in patients with FP ISR following treatment with angioplasty. 22 Several strategies have been attempted to treat FP ISR to improve on angioplasty results.…”

“…[1][2][3][4][5] Debulking of FP ISR lesions has been attempted to lessen restenotic tissue burden and improve patency while reducing target lesion revascularization (TLR). [5][6][7][8][9][10][11][12][13] Recently, laser atherectomy of FP ISR was shown to reduce TLR at 6 months and 1 year when compared with balloon angioplasty alone.…”