Drug-Coated Balloon versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and/or Popliteal Peripheral Artery Disease: 12-Month Results from the IN.PACT SFA Randomized Trial
Background—Drug-coated balloons (DCB) have shown promise in improving outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and/or popliteal artery disease.
Methods and Results—The IN.PACT SFA Trial is a prospective, multicentre, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain due to superficial femoral and/or popliteal peripheral artery disease (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. Baseline characteristics were similar between the 2 groups. 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=.82) and 25.8% and 19.5% (P=.22), respectively. DCB resulted in higher primary patency vs. PTA (82.2% vs. 52.4%; P<.001). The rate of clinically-driven target lesion revascularization was 2.4% in the DCB arm compared with 20.6% in the PTA arm (P<.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA (P=.10)). There were no device- or procedure-related deaths and no major amputations.
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 femoropopliteal PAD.
- Drug Coated Balloons
- Superficial Femoral Artery Disease
- Popliteal Artery Disease
- peripheral vascular disease
- balloon angioplasty
- Received May 5, 2014.
- Revision received November 3, 2014.
- Accepted November 19, 2014.