Initial Results of Standard Balloon Angioplasty Versus Drug Coated Balloon Alone Versus in Association With Laser Excimer Atherectomy in the Treatment of Femoropopliteal Artery In Stent Restenosis (INTACT)

Endovascular management is indicated for lifestyle limiting claudication after failed medical management and for chronic limb threatening ischaemia in cases of femoropopliteal disease < 25 cm or lack of venous conduit. Despite improved stent designs, half of the patients require secondary procedures for in stent re-stenosis (ISR), which occurs in 68.7% of non-focal lesions at 24 months.1 While re-stenotic lesions classified as Tosaka class I (focal lesions ≤ 5 cm in length on angiography) can be treated effectively with basic strategies, lesions of increasing complexity (class II: diffuse lesions > 50 cm in length, and class III: totally occluded) show poor outcomes with conventional approaches.1 The Femoral Artery ISR (FAIR) trial demonstrated superiority of drug coated balloons (DCBs) over percutaneous transluminal angioplasty (PTA).2 The EXCImer Laser Atherectomy (ELA) randomised controlled trial (RCT) for Treatment of FemoropopliTEal ISR (EXCITE-ISR) demonstrated superiority of ELA + PTA vs. PTA alone.3 However, the best treatment strategy remains unclear.