Effects of Statin Therapy in Patients Treated with Drug-Eluting and Drug-Coated Stents for Femoropopliteal Lesions: STAR-FP Study Outcomes

Abstract

Background The effects of statins on drug-eluting stents (DESs) and drug-coated stents (DCSs) for femoropopliteal (FP) lesions are not well known. Therefore, this multicenter retrospective evaluated the impact of statins on DES and DCS patency. Methods Between January 2018 and December 2021, 449 patients were treated with DES and DCS at eight cardiovascular centers in Japan (LEADers FP registry). These lesions were divided into statin-treated and non-statin-treated arms. After propensity score matching, the effects of statins on DES and DCS were evaluated. The 2-year primary outcome measure was stent patency. The secondary outcomes included secondary patency, clinically driven target lesion revascularization (CD-TLR), limb salvage, major adverse limb events (MALE, CD-TLR+ major amputation), and a composite of overall survival and MALE or all-cause death at 2 years. Results After propensity score matching, the baseline and procedural characteristics did not differ significantly between the 135 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 (86.9% vs. 75.1%, p=0.041). Regarding the secondary endpoints, the statin group demonstrated significantly superior secondary patency and freedom from MALE or all-cause mortality (95.5% vs. 87.0%, p=0.023 and 73.7% vs. 60.0%, p=0.012, respectively). Conclusions The results of this retrospective multicenter study demonstrated the superior primary patency in the statin group compared with the non-statin group at two years. These findings suggest that statins improve patency in patients undergoing DES and DCS.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Conflicts of interest: None

Funding Statement

This study received no funding to support the research.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Approval was obtained from the Ethics Committee of Tenyoukai Central Hospital.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The datasets used and/or analyzed in this study are available from the corresponding author upon reasonable request.

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