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  • 12-Months Results From the PRESTIGE Study Using Sirolimus Drug-Eluting Balloons in the Treatment of Complex BTK Tibial Atherosclerotic Lesions in CLTI Patients

    The PRESTIGE study ( NCT04071782 ) is a physician-initiated pilot study assessing the SELUTION SLR™ (M. A. MedAlliance SA, Nyon, Switzerland) drug eluting balloon (DEB) in chronic limb threatening ischaemia (CLTI) patients with TASC II C/D tibial atherosclerotic lesions. Sirolimus is a potent antiproliferative agent that prevents smooth muscle cell activation and reduces inflammatory cell recruitment after vascular injury. Tibial angioplasty in the CLTI setting is dogged by high restenosis rates because of elastic recoil and neointimal hyperplasia (NIH)  , and this accounts for increased clinically driven target lesion revascularization (CD-TLR) interventions and morbidity and reduces limb salvage rates  . SELUTION SLR™ elutes sirolimus into the arterial wall over a 90-day period to inhibit the restenotic and NIH processes  . PRESTIGE has previously shown good safety and efficacy data using SELUTION SLR™ at 6-months, a world's-first experience using sirolimus in the below-the-knee (BTK) arena  . The aim of this communication is to report 12-month outcomes.

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