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. XXXX SFA Randomized Trial.

@entity1 @entity455 @entity3657 @entity63 @entity75 @entity613 @entity15649 @entity158 @entity715 @entity204
BACKGROUND: -Drug-coated balloons (DCB) have shown promise in improving outcomes for @entity1 with @entity3657 . We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and/or popliteal @entity455 . METHODS AND RESULTS: -The IN. @entity15649 SFA Trial is a prospective, multicentre, single-blinded, randomized trial in which 331 @entity1 with @entity613 or @entity63 @entity158 due to superficial femoral and/or popliteal @entity3657 ( @entity3657 ) 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 @entity75 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 @entity75 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 @entity715 in both arms (1.4% after DCB and 3.7% after PTA (P=.10)). There were no device- or procedure-related @entity204 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 @entity1 with symptomatic femoropopliteal @entity3657 . Clinical Trial Registration Information-ClinicalTrials.gov. Identifiers: NCT01175850 and NCT01566461.
