Femoral Artery In-Stent Restenosis - FAIR
The goal of the trial was to assess the safety and efficacy of drug-coated balloon (DCB) compared with balloon angioplasty alone in patients with in-stent restenosis (ISR) in the superficial femoral artery (SFA).
Contribution to the Literature: The FAIR trial showed that paclitaxel-coated balloon is safe and effective compared with balloon angioplasty alone for the treatment of ISR in the SFA.
Patients with SFA ISR were randomized in a 1:1 fashion to either DCB (n = 62) or routine balloon angioplasty (n = 57). All DCBs were coated with paclitaxel (dose 3.5 μg/mm2).
- Total number of enrollees: 119
- Duration of follow-up: 12 months
- Mean patient age: 68 years
- Percentage female: 59%
- SFA ISR of up to 20 cm in length
- Diameter stenosis ≥70% on ultrasound
- Popliteal artery as well as one of the infrapopliteal (below-the-knee) vessels had to be patent (50% stenosis) for sustained distal run-off
- Chronic limb ischemia of Rutherford category 2-4
- Untreated ipsilateral iliac artery stenosis
- Ongoing dialysis treatment
- Treatment with oral anticoagulants other than antiplatelet agents
Other salient features/characteristics:
- Diabetes: 37%
- Active smoking: 32%
- Coronary artery disease: 41%
- Cardiovascular disease: 20%
- Ankle-brachial index (ABI): 0.64
- Rutherford category 2/3: 92%
- Reference vessel diameter: 5.3 mm
- Lesion length: 82 mm
- Total occlusions: 29%
The primary endpoint was binary recurrent ISR by ultrasound at 6 months for DCB vs. balloon angioplasty: 15.4% vs. 44.7% (p = 0.002)
Secondary outcomes (DCB vs. balloon angioplasty alone):
- Angiographic success: 95.1% vs. 78.9%, p = 0.1
- Final ABI at discharge: 0.94 vs. 0.81
- Recurrent ISR by ultrasound at 12 months: 29.5% vs. 62.5%, p = 0.004
- Freedom from target lesion revascularization (TLR) at 12 months: 90.8% vs. 52.6%, p < 0.0001
- All-cause mortality at 12 months: 4.3% vs. 6.8%, p = 0.59
- Thrombosis at 12 months: 2.1% vs. 4.5%, p = 0.52
The results of this trial indicate the DCB is safe and effective for the treatment of ISR in the SFAs. At 12 months, binary restenosis was close to 30% with DCB angioplasty, but clinical TLR was <10%. These outcomes are fairly similar to those observed with DCB angioplasty in de novo lesions. This is an important trial because long-term patency following SFA ISR treatment remains poor. A number of different options are pursued including balloon angioplasty, atherectomy, DCB, brachytherapy, and repeat stenting. Head-to-head comparisons with other treatment options and cost-effectiveness analyses are also necessary.
Note that the lesion length in this trial was intermediate (median 82 mm), and thus, the efficacy of DCBs in longer lesion lengths remains unclear. Further longer-term follow-up data are awaited.
Krankenberg H, Tübler T, Ingwersen M, et al. Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. Circulation 2015;132:2230-6.
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