Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial

Gunnar Tepe, John Laird, Peter Schneider, Marianne Brodmann, Prakash Krishnan, Antonio Micari, Christopher Metzger, Dierk Scheinert, Thomas Zeller, David J Cohen, David B Snead, Beaux Alexander, Mario Landini, Michael R Jaff, IN.PACT SFA Trial Investigators, Gunnar Tepe, John Laird, Peter Schneider, Marianne Brodmann, Prakash Krishnan, Antonio Micari, Christopher Metzger, Dierk Scheinert, Thomas Zeller, David J Cohen, David B Snead, Beaux Alexander, Mario Landini, Michael R Jaff, IN.PACT SFA Trial Investigators

Abstract

Background: Drug-coated balloons (DCBs) have shown promise in improving the 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 popliteal artery disease.

Methods and results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point 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 the percentage 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 versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). 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 peripheral artery disease.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461.

Keywords: drug-eluting balloons; peripheral arterial disease; peripheral vascular diseases.

© 2014 The Authors.

Figures

Figure 1.
Figure 1.
Trial flow diagram. The IN.PACT SFA Trial used a 2:1 randomized, control design, and intent-to-treat (ITT) analysis was conducted at 12 months. Three hundred thirty-one (331) patients with de novo or nonstented restenotic lesions in the superficial femoral and proximal popliteal artery were randomly assigned either to the IN.PACT Admiral drug-coated balloon or standard PTA treatment group. All subjects enrolled in the IN.PACT SFA Trial (n=331) will be followed for up to 5 years. Analysis at 1 year included subjects that provided end point data at the time of data snapshot. A subject was excluded under the following circumstances: (1) consent was withdrawn before the 1-year visit and no event had occurred before withdrawal or (2) there was no contact with the subject permitting a 1-year evaluation and no events had occurred before the 1-year evaluation. DCB indicates drug-coated balloon; PTA, percutaneous transluminal angioplasty; and SFA, superficial femoral artery.
Figure 2.
Figure 2.
Twelve-month freedom from target lesion revascularization. Freedom from target lesion revascularization in 331 patients with superficial femoral and popliteal peripheral artery disease were randomly assigned to receive drug-coated balloons or standard angioplasty. The rate of freedom from clinically driven TLR was significantly higher in the group receiving drug-coated balloons than in the standard PTA group. PTA indicates percutaneous transluminal angioplasty; and TLR, target lesion revascularization.

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