Efficacy of Supera Stent in the Treatment of Complex Femoropopliteal Artery Lesions: A Short-Term Result Analysis of Real-World Evidence.

ABSTRACT

BACKGROUND: When dealing with complex femoropopliteal lesions, there is a growing preference for the utilization of drug-coated balloons (DCBs) or stents. However, in real-world scenarios, a greater number of elderly patients with longer lesion lengths are encountered. The purpose of our study was to compare the efficacy and safety of different interventional strategies, including the utilization of Supera stent and DCB, in a real-world setting. METHODS: This was a retrospective study that collected treatment and follow-up data of patients with complex femoropopliteal artery lesions treated between January 2019 and March 2022. All patients were categorized into 3 groups "non-Supera stent group," "Supera stent group," and "Supera stent + DCB group." The primary effectiveness outcome was primary patency at 12 months, defined as duplex ultrasound peak systolic velocity ratio < 2.5 at the 12-month visit. Other outcomes included improvements in Rutherford categories and safety. RESULTS: A total of 162 patients were enrolled in this study. Compared with non-Supera group (47.6%) in the primary patency rate at 12 months, Supera group (58.7%) or Supera + DCB group (60.0%) showed no significant difference. There were no significant differences in all-cause death, major amputation of the target limb, and target lesion revascularization between the groups. Supera group showed a significant improvement in Rutherford category without target lesion revascularization at 12 months compared with non-Supera group (73.3% vs. 54.8%, P = 0.041). In 12-month follow-up, more than 65% of patients maintained a Rutherford category of 3 or in the following, particularly in Supera group where 74.7% of patients had mild symptoms. CONCLUSIONS: The Supera stent has demonstrated its efficacy and safety in treating complex peripheral artery disease. However, combining Supera stent with DCB did not provide a significant advantage. Furthermore research is necessary to validate these findings in a larger patient population.