Endovascular treatment in femoropopliteal territory has become the strategy of choice over time, with diverse devices; among others, drug coated balloons (DCB). DBS are meant to provide the antiproliferation effect of drugs while reducing exposure of a specific artery segment to a strange body.
Even though the number of studies on DCB effectiveness has been growing over the years, there are few data on the mechanisms behind DCB failure.
The aim of this study was to look into clinical characteristics, anatomical factors and procedural variables related to DCB failure in femoropopliteal territory.
Data pooled from several studies using Paclitaxel IN.PACT Admiral DCB (among others, the IN.PACT SFA, MDT-2113 and the IN.PACT Global) were looked at retrospectively, which left them out with a population from 83 sites in 17 countries.
Primary end point was primary patency loss (freedom form clinically driven target lesion revascularization (TLR), and freedom from binary stenosis) during a 12-month followup.
Data from 557 patients were obtained, with single lesions treated with IN.PACT Admiral DCB, mean age was 70, 67.5% were men, 87% were hypertensive, 40.5% diabetic and 38.2% were smokers. 46% of cases presented prior peripheral intervention, and most were in Rutherford class II (33%) and III (57.2%).
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After 12 months, primary patency loss was 17.5%, binary restenosis 15.6% and clinically driven TLR 5.3%. Multivariable analysis of variables associated with patency loss at followup were residual stenosis >30% (HR: 2.94, CI 95%: 1.76-4.92; P<0.001).
The presence of residual stenosis associated to a reference diameter of the reduced vessel was linked to a 57% increase in binary restenosis (HR: 1.57, CI 95% 1.01-2.46; P=0.046). Patients with residual stenosis in Rutherford class III presented higher risk of clinically driven TLR (HR 4.19, IC 95% 1.68-10.46; P=0.002).
Conclusions
This analysis of patients pooled from studies using the IN.PACT Admiral DCB showed some factors that can predict patency failure at 12 months. Those with the highest impact were residual stenosis >30% after procedure, smaller reference diameter, and Rutherford class III.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention.
Reference: Krishnan, Prakash et al. “Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention.” Journal of the American College of Cardiology vol. 80,13 (2022): 1241-1250. doi:10.1016/j.jacc.2022.06.043.
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