Retrievable scaffold therapy before paclitaxel drug-coated balloon angioplasty in infrapopliteal arteries: one-year outcomes of the DEEPER OUS Study

Percutaneous transluminal angioplasty (PTA) is a common treatment for infrapopliteal artery disease, but acute elastic recoil and restenosis limit its efficacy. While drug-coated balloons (DCBs) may reduce restenosis by delivering antiproliferative agents to the arterial wall, studies comparing DCBs to PTA have been inconclusive. Retrievable scaffold therapy (RST) utilises a spur stent with microspikes that create microchannels in the arterial wall to enhance DCB drug delivery. The prospective, multicentre, single-arm DEEPER OUS Study (ClinicalTrials.gov: NCT03807531) evaluated RST prior to paclitaxel DCB angioplasty for infrapopliteal disease.

Independent core laboratories evaluated duplex ultrasound and angiographic imaging. An independent clinical events committee adjudicated device-related adverse events, and an independent data safety monitoring board provided study oversight. The study enrolled adults with peripheral artery disease (Rutherford-Becker classification [RBC] 3-5) and infrapopliteal disease with lesion lengths of 30-150 mm and reference vessel diameters of 2.0-4.5 mm (Supplementary Table 1). Patients were treated with RST (Spur Peripheral Retrievable Scaffold System [Reflow Medical]), a temporary self-expanding nitinol stent, prior to DCB angioplasty (Supplementary Figure 1). The primary efficacy endpoint was primary patency at 6 months...