Objectives
The aim of this study was to evaluate the 24-month outcome of drug-coating balloon (DCB) versus bare-metal stent (BMS) for the treatment of disabling claudication and critical limb ischemia in patients with complex femoropopliteal lesions regarding technical success, primary patency, secondary patency, target lesion revascularization, and limb salvage rate.
Background
Complex femoropopliteal lesions are difficult to treat, and the effective protocols for intervention remain to be developed.
Patients and methods
This was a multicenter, prospective, randomized controlled two-arm blind interventional study. A total of 80 patients (92 limbs) complaining of disabling claudication or critical limb ischemia owing to complex femoropopliteal occlusive lesions were randomly assigned into two groups according to the intervention approach used from May 2016 to August 2020. Group A included 42 patients (47 limbs) who have been assigned for treatment with paclitaxel DCBs and group B included 38 patients (45 limbs) assigned for treatment with BMSs. The follow-up period was for 24 months, with regular visits at 3, 6, 9, 12, 15, 18, and 24 months or when new concerns emerged. All data were analyzed by using Statistical Package of Social Science for Windows, version 22.0 and MedCalc Windows.
Results
The 1-year primary patency rates in the DCB and BMS groups were 87.2 and 75.6% (=0.15), respectively, and the corresponding 2-year rates were 76.6 and 57.8, respectively (=0.05). However, the 1-year secondary patency rates in the DCB and BMS groups were 95.7 and 91.1% (=0.43), respectively, and the corresponding 2-year rates were 91.4 and 75.5%, respectively (=0.05). There is a statistically significant difference regarding the primary and secondary patency rates at 24 months between both the groups (=0.05). The 2-year major limb amputation rate was 6.3% in DCB group versus 11.1% in BMS group (=0.48), which was statistically insignificant. The postprocedural ankle–brachial index shows highly significant difference between both the groups at 24 months (<0.001).
Conclusion
The 2-year outcomes showed superior efficacy, higher safety, and greater clinical benefits of DCBs than BMSs for the treatment of complex femoropopliteal lesions. A statistically significant lower rate of restenosis and occlusions and statistically significant higher 2-year primary and secondary patency rates were observed in the DCB group than in the BMS group. However, more studies with a larger sample and long-term follow-up are required.