FAIR Trial Compares DEB Versus PTA for Treating SFA In-Stent Restenosis

January 30, 2014—A study comparing standard balloon angioplasty versus angioplasty with a paclitaxel-eluting balloon for femoral artery in-stent restenosis (FAIR) was presented by principal investigator Hans Krankenberg, MD, at LINC 2014: the Leipzig Interventional Course in Leipzig, Germany. Dr. Krankenberg is from the Heart and Vascular Center in Bad Bevensen, Germany.

Dr. Krankenberg presented 6- and 12-month data from the FAIR trial, which was a comparison of recurrent restenosis rates after treatment of in-stent restenoses (ISR) or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon, the Admiral Xtreme (Medtronic, Inc., Minneapolis, MN) (n = 57), or a paclitaxel-eluting balloon, Medtronic’s In.Pact Admiral (n = 62). According to Dr. Krankenberg, the FAIR investigators concluded that angioplasty of femoropopliteal ISR with the In.Pact DEB is safe and efficacious and that the In.Pact DEB results in a significant decrease in restenosis and clinically driven reinterventions compared with PTA through 6 and 12 months. The investigators found that major adverse vascular events (MAVE) through 12 months are similarly low in both study cohorts and that clinical and functional benefit were similar at 12 months; in addition, the PTA arm showed significantly higher target lesion revascularization (TLR). Final core lab evaluation is forthcoming, advised Dr. Krankenberg.

The investigator-initiated, core lab-adjudicated, prospective, multicenter, randomized trial enrolled 119 patients at five German medical centers from January 2010 to November 2012. Key inclusion criteria were clinical presentation of Rutherford class 2–4; angiographic determination by Doppler ultrasound of SFA ISR of 70% to 100%; target lesion length measured by ruler of 1 to 20 cm; a patent popliteal artery; and at least one patent infrapopliteal artery.

The study’s primary endpoint was binary (≥ 50%) restenosis rate at 6 months determined by duplex ultrasound core lab adjudication (peak systolic velocity ratio ≥ 2.4). Secondary endpoints include primary angiographic success (< 50% residual stenosis); 6-month recurrent ISR (≥ 70%); 12-month recurrent ISR (≥ 50%); 6- and 12-month clinically driven TLR; clinical/hemodynamic assessment (walking distance, ankle-brachial index [ABI], Rutherford category) at 1, 6, and 12 months; and MAVE at 12 months.

Dr. Krankenberg reported that the 6-month recurrent restenosis rate (site-reported binary restenosis ≥ 50%), the study’s primary endpoint, was 15.4% for DEB versus 44.7% for PTA (P = .002). The 6-month secondary patency rate was 87% versus 65.2% (P = .026). At 12 months, the recurrent restenosis rate was 29.5% versus 62.5% (P = .004) and the secondary patency rate was 80% versus 77.3% (P = .804).

At 390 days after the index procedure, the freedom from TLR, based on restenosis/reocclusion and symptoms, was 90.8% for DEB versus 52.6% for PTA (P = .0001). Outcomes of DEB versus PTA were also measured by walking capacity­—absolute claudication distance in 6-minute walk test—at baseline (131.4 vs 145.9), 6 months (201.3 vs 216.6), and 12 months (212.4 vs 203). ABI was measured at baseline (0.628 vs 0.653), 6 months (0.892 vs 0.793), and 12 months (0.856 vs 0.866). For the DEB, as compared with PTA, the cumulative MAVE rates at 6 months were 0% versus 2.1% (death, 2.1%). At 12 months, the cumulative MAVE rate was 6.4% (death, 4.3%; surgical intervention, 2.1%) for DEB and 6.8% (death, 4.5%; thrombosis, 2.3%) for PTA, reported Dr. Krankenberg for the FAIR investigators.