OBJECTIVE: The effects of statins on drug-eluting and drug-coated stents for femoropopliteal lesions are not well known. Therefore, this multicenter retrospective study evaluated the impact of statins on the patency of drug-eluting and drug-coated stents. METHODS: Between January 2018 and December 2021, 449 patients were treated with drug-eluting and drug-coated stents at eight cardiovascular centers in Japan (LEADers femoropopliteal lesion registry). These lesions were divided into statin-treated and non-statin-treated arms. After propensity-score matching, the effects of statins on drug-eluting and drug-coated stents were evaluated. The primary outcome was the 2-year primary patency in the statin and non-statin groups. The secondary outcomes included secondary patency, freedom from clinically driven target lesion revascularization, and freedom from all-cause mortality at two years. RESULTS: After propensity-score matching, the baseline characteristics did not differ significantly between the 134 patient pairs in the statin and non-statin groups. The primary patency at two years was significantly better in the statin group than in the non-statin group (87.3% vs. 75.8%, p = 0.043). In terms of secondary outcomes, the statin group tended to have better secondary patency than the non-statin group (94.4% vs. 87.5%, p = 0.064). There was no significant difference between groups in freedom from clinically driven target lesion revascularization and freedom from all-cause mortality (90.8% vs. 84.7%, p = 0.15
75.8% vs. 70.7%, p = 0.31, respectively). CONCLUSIONS: The results of this study demonstrated that the statin group had superior primary patency compared with that of the non-statin group at two years. These findings suggest that statins improve the patency of implanted drug-eluting or drug-coated stents for femoropopliteal lesions.