The following is a summary of “Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease,” published in the January 2023 issue of Cardiology by Shishehbor, et al.

Drug-coated balloons (DCB) were used more often in endovascular therapy of femoropopliteal artery disease. However, there were few data on the safety and effectiveness of DCB compared to bare-metal stents (BMS).

For a study, researchers compared the results of 4 prospective, multicenter studies using propensity-adjusted pooled analysis to compare DCB vs. BMS.

Patient-level information was combined from four prospective, multicenter studies: the Complete SE and DURABILITY II single-arm BMS investigations, the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials. Utilizing inverse probability of treatment weighting (IPTW), outcomes were compared. Clinical outcomes included cumulative 36-month major adverse events (MAE), 12-month primary patency, and independence from 36-month clinically induced target lesion revascularization.

771 patients were included in the main analysis (288 DCB, 483 BMS). Demographic, baseline lesion, and procedural characteristics were matched between groups after IPTW adjustment. The average lesion length after adjustment was 7.9 ± 4.55 cm BMS and 8.1 ± 4.7 cm DCB. IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), absence of 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P< 0.001) all showed favorability for DCB. Through 36 months, there were no statistically significant changes in thrombosis, target limb major amputation, or all-cause death.

In a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal trials, DCB showed statistically insignificant differences in mortality, amputation, or thrombosis compared to BMS but considerably greater patency decreased revascularization and MAE rates. In somewhat complicated femoropopliteal lesions susceptible to both therapies, the research supported the use of DCB over BMS.

Reference: jacc.org/doi/10.1016/j.jacc.2022.10.016