Drug-Coated Balloons vs Standard Percutaneous Transluminal Angiopathy for the Treatment of Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery Disease: New Insights from the IN.PACT SFA Randomized Trial

Abstract

Purpose Drug-coated balloons (DCB) have shown promise in improving outcomes for patients with peripheral artery disease (PAD). Twelve-month outcomes following treatment of symptomatic femoro-popliteal disease with a paclitaxel-coated balloon versus treatment with percutaneous transluminal angioplasty (PTA) were compared. Material and Methods The IN.PACT Superficial Femoral Artery (SFA) Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain due to femoro-popliteal PAD were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy endpoint was primary patency, defined as freedom from restenosis or clinically driven target-lesion revascularization at 12 months. Results Baseline characteristics were similar between the 2 groups. The mean lesion length and percent of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (p = 0.82) and 25.8% and 19.5% (p = 0.22), respectively. DCB resulted in higher primary patency vs. PTA (82.2% vs. 52.4%; p 0.15). Primary patency (75.7% vs. 43.8%; p = 0.004) and clinically driven TLR (4.1% vs. 25.7%; p Conclusions In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoro-popliteal PAD. The DCB response was consistent between genders and showed favorable results in females