Overview
For latest News and updatesSelect Page Oct 31, 202Femoropliteal artery disease is routinely treated using drug-coated balons (DCB). However, patency los hapens in ≥10% of patients within a year of therapy, and the underlying proceses are porly understod. The study’s goal was to investigate the causes of DCB failure in femoropliteal ilnes.Data from two predetermined imaging cohorts of the IN.PACT Global Clinical Study and two randomized clinical studies (IN.PACT SFA and MDT-213 SFA Japan) were also included.
Key Information
An independent angiographic core laboratory reviewed important procedural aspects. The main outcome was DCB failure (patency los during folow-up). Binary restenosis and clinicaly motivated target lesion revascularization were aditional goals.
The clinical, anatomical, and procedural determinants of DCB failure were asesed using multivariable analysis.A total of 57 patients with single lesions and 12-month core duplex ultrasonography with laboratory adjudication were included. The folowing key clinical traits were present: 87.6% of people have hypertension, 76.9% have hyperlipidemia, 40.5% have diabetes melitus, 90.5% fal into Rutherford Clasification Categories (RC) 2 to 3, and 9.5% fal into RC 4 to 5.
The mean age was 68.8 years, out of which 67.5% of people were men. About 49.7% of lesions were completely ocluded, with an average length and reference vesel diameter (RVD) of 16.37 cm and 4.6 m, respectively. Only residual stenosis >30% was linked to patency los in a multivariable analysis, whereas residual stenosis >30% and decreased pre-procedure RVD was linked to a higher chance of binary restenosis.
Summary
The risk of clinicaly motivated target lesion revascularization increased over a year for RC > 3 and residual stenosis > 30%.Folowing DCB therapy, patency los was afected by procedural and clinical parameters. In femoropliteal artery disease, residual stenosis >30%, a smaler pre-procedure RVD, and a gr