ISAR‐PEBIS (Paclitaxel‐Eluting Balloon Versus Conventional Balloon Angioplasty for In‐Stent Restenosis of Superficial Femoral Artery): A Randomized Trial

<jats:sec xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en"> Paclitaxel‐eluting balloon ( <jats:styled-content style="fixed-case">PEB</jats:styled-content> ) angioplasty has superior efficacy compared with conventional balloon angioplasty ( <jats:styled-content style="fixed-case">BA</jats:styled-content> ) for de novo lesions of superficial femoral artery ( <jats:styled-content style="fixed-case">SFA</jats:styled-content> ). Studies investigating the angiographic and clinical performance of PEB angioplasty versus <jats:styled-content style="fixed-case">BA</jats:styled-content> for in‐stent restenosis of <jats:styled-content style="fixed-case">SFA</jats:styled-content> are limited. We performed a randomized trial to investigate angiographic and clinical performance of <jats:styled-content style="fixed-case">PEB</jats:styled-content> versus <jats:styled-content style="fixed-case">BA</jats:styled-content> for in‐stent restenosis of <jats:styled-content style="fixed-case">SFA</jats:styled-content> . </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> Patients with symptomatic in‐stent restenosis of <jats:styled-content style="fixed-case">SFA</jats:styled-content> were randomly assigned to either <jats:styled-content style="fixed-case">PEB</jats:styled-content> or <jats:styled-content style="fixed-case">BA</jats:styled-content> at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6‐ to 8‐month follow‐up angiography. Secondary end points were the rate of binary restenosis at follow‐up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all‐cause mortality at 24‐month follow‐up. Seventy patients were assigned to <jats:styled-content style="fixed-case">PEB</jats:styled-content> (n=36) or <jats:styled-content style="fixed-case">BA</jats:styled-content> (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, <jats:italic>P</jats:italic> =0.01) and binary restenosis were significantly reduced with <jats:styled-content style="fixed-case">PEB</jats:styled-content> versus <jats:styled-content style="fixed-case">BA</jats:styled-content> (30% versus 59%, <jats:italic>P</jats:italic> =0.03). At 24‐month follow‐up, <jats:styled-content style="fixed-case">PEB</jats:styled-content> was associated with a significant reduction of target lesion revascularization in comparison to <jats:styled-content style="fixed-case">BA</jats:styled-content> (19% versus 50%, <jats:italic>P</jats:italic> =0.007). There was no difference with respect to other outcomes of interest. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en"> In patients with in‐stent restenosis of <jats:styled-content style="fixed-case">SFA</jats:styled-content> , a percutaneous therapy with <jats:styled-content style="fixed-case">PEB</jats:styled-content> compared with <jats:styled-content style="fixed-case">BA</jats:styled-content> has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24‐month follow‐up. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Clinical Trial Registration</jats:title> <jats:p xml:lang="en"> <jats:styled-content style="fixed-case">URL</jats:styled-content> : <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: <jats:styled-content style="fixed-case">NCT</jats:styled-content> 01083394. </jats:p> </jats:sec>