Femoropopliteal artery disease is routinely treated using drug-coated balloons (DCB). However, patency loss happens in ≥10% of patients within a year of therapy, and the underlying processes are poorly understood. The study’s goal was to investigate the causes of DCB failure in femoropopliteal illness.
Data from two predetermined imaging cohorts of the IN.PACT Global Clinical Study and two randomized clinical studies (IN.PACT SFA and MDT-2113 SFA Japan) were also included. An independent angiographic core laboratory reviewed important procedural aspects. The main outcome was DCB failure (patency loss during follow-up). Binary restenosis and clinically motivated target lesion revascularization were additional goals. The clinical, anatomical, and procedural determinants of DCB failure were assessed using multivariable analysis.
A total of 557 patients with single lesions and 12-month core duplex ultrasonography with laboratory adjudication were included. The following key clinical traits were present: 87.6% of people have hypertension, 76.9% have hyperlipidemia, 40.5% have diabetes mellitus, 90.5% fall into Rutherford Classification Categories (RCC) 2 to 3, and 9.5% fall into RCC 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 occluded, with an average length and reference vessel diameter (RVD) of 16.37 cm and 4.66 mm, respectively. Only residual stenosis >30% was linked to patency loss in a multivariable analysis, whereas residual stenosis >30% and decreased pre-procedure RVD was linked to a higher chance of binary restenosis. The risk of clinically motivated target lesion revascularization increased over a year for RCC > 3 and residual stenosis > 30%.
Following DCB therapy, patency loss was affected by procedural and clinical parameters. In femoropopliteal artery disease, residual stenosis >30%, a smaller pre-procedure RVD, and a greater RCC may be thought of as predictors of a higher chance of DCB failure and its components.