Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease

Background: The beneficial outcomes of ezetimibe plus statin therapy are well-established in coronary artery disease, but these remain unknown in lower extremity artery disease (LEAD). Objectives: This study evaluated the efficacy of an intensified lipid-lowering strategy involving ezetimibe plus st...

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Main Authors: Yoshihiro Iwasaki, MD, PhD, Takenobu Shimada, MD, PhD, Takefumi Kishimori, MD, Atsuyuki Wada, MD, PhD, Jumpei Koike, MD, Takehiro Matsumoto, MD, PhD, Takafumi Yagi, MD, Masaharu Okada, MD, PhD
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:JACC: Advances
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Online Access:http://www.sciencedirect.com/science/article/pii/S2772963X25004995
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author Yoshihiro Iwasaki, MD, PhD
Takenobu Shimada, MD, PhD
Takefumi Kishimori, MD
Atsuyuki Wada, MD, PhD
Jumpei Koike, MD
Takehiro Matsumoto, MD, PhD
Takafumi Yagi, MD
Masaharu Okada, MD, PhD
author_facet Yoshihiro Iwasaki, MD, PhD
Takenobu Shimada, MD, PhD
Takefumi Kishimori, MD
Atsuyuki Wada, MD, PhD
Jumpei Koike, MD
Takehiro Matsumoto, MD, PhD
Takafumi Yagi, MD
Masaharu Okada, MD, PhD
author_sort Yoshihiro Iwasaki, MD, PhD
collection DOAJ
description Background: The beneficial outcomes of ezetimibe plus statin therapy are well-established in coronary artery disease, but these remain unknown in lower extremity artery disease (LEAD). Objectives: This study evaluated the efficacy of an intensified lipid-lowering strategy involving ezetimibe plus statins vs statin monotherapy for reducing major adverse limb events and mortality in patients with LEAD. Methods: This retrospective analysis included patients aged ≥18 years diagnosed with LEAD from the TriNetX global health care database from 2013 to 2022, excluding those with recent acute coronary syndrome or stroke. The primary outcome was the 12-month cumulative incidence of major lower limb amputation and all-cause death as a composite endpoint. Propensity score matching was used to adjust for baseline characteristics and confounders, yielding 4,204 patients in each group. Results: The composite endpoint was lower with statins plus ezetimibe vs statin monotherapy (5.8% vs 10.2%; P < 0.001; HR: 0.54; 95% CI: 0.46-0.64). Taken individually, both major lower limb amputation (2.7% vs 4.6%; P < 0.001; HR: 0.57; 95% CI: 0.45-0.72) and all-cause death (3.4% vs 6.3%; P < 0.001; HR: 0.52; 95% CI: 0.42-0.65) were significantly lower with combination therapy. Subgroup analyses showed consistent effects across all subgroups. Conclusions: Compared to statin monotherapy, an intensified lipid-lowering strategy (ie, ezetimibe plus statins), significantly reduced the incidence of major lower limb amputation and all-cause mortality in real-world patients with LEAD.
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spelling doaj-art-cdd7a1fd8244409fa9bf6eae10f9122c2025-08-20T03:46:54ZengElsevierJACC: Advances2772-963X2025-09-014910207410.1016/j.jacadv.2025.102074Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery DiseaseYoshihiro Iwasaki, MD, PhD0Takenobu Shimada, MD, PhD1Takefumi Kishimori, MD2Atsuyuki Wada, MD, PhD3Jumpei Koike, MD4Takehiro Matsumoto, MD, PhD5Takafumi Yagi, MD6Masaharu Okada, MD, PhD7Department of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanDepartment of Cardiovascular Medicine, Osaka Metropolitan University Graduate School of Medicine, Osaka, JapanDepartment of Cardiovascular Medicine, Omi Medical Center, Kusatsu, Japan; Address for correspondence: Dr Takefumi Kishimori, Department of Cardiovascular Medicine, Omi Medical Center, 1660 Yabase, Kusatsu, Shiga 525-8585, Japan.Department of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanDepartment of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanDepartment of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanDepartment of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanDepartment of Cardiovascular Medicine, Omi Medical Center, Kusatsu, JapanBackground: The beneficial outcomes of ezetimibe plus statin therapy are well-established in coronary artery disease, but these remain unknown in lower extremity artery disease (LEAD). Objectives: This study evaluated the efficacy of an intensified lipid-lowering strategy involving ezetimibe plus statins vs statin monotherapy for reducing major adverse limb events and mortality in patients with LEAD. Methods: This retrospective analysis included patients aged ≥18 years diagnosed with LEAD from the TriNetX global health care database from 2013 to 2022, excluding those with recent acute coronary syndrome or stroke. The primary outcome was the 12-month cumulative incidence of major lower limb amputation and all-cause death as a composite endpoint. Propensity score matching was used to adjust for baseline characteristics and confounders, yielding 4,204 patients in each group. Results: The composite endpoint was lower with statins plus ezetimibe vs statin monotherapy (5.8% vs 10.2%; P < 0.001; HR: 0.54; 95% CI: 0.46-0.64). Taken individually, both major lower limb amputation (2.7% vs 4.6%; P < 0.001; HR: 0.57; 95% CI: 0.45-0.72) and all-cause death (3.4% vs 6.3%; P < 0.001; HR: 0.52; 95% CI: 0.42-0.65) were significantly lower with combination therapy. Subgroup analyses showed consistent effects across all subgroups. Conclusions: Compared to statin monotherapy, an intensified lipid-lowering strategy (ie, ezetimibe plus statins), significantly reduced the incidence of major lower limb amputation and all-cause mortality in real-world patients with LEAD.http://www.sciencedirect.com/science/article/pii/S2772963X25004995all-cause mortalityezetimibeLEADmajor lower limb amputationstatin
spellingShingle Yoshihiro Iwasaki, MD, PhD
Takenobu Shimada, MD, PhD
Takefumi Kishimori, MD
Atsuyuki Wada, MD, PhD
Jumpei Koike, MD
Takehiro Matsumoto, MD, PhD
Takafumi Yagi, MD
Masaharu Okada, MD, PhD
Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
JACC: Advances
all-cause mortality
ezetimibe
LEAD
major lower limb amputation
statin
title Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
title_full Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
title_fullStr Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
title_full_unstemmed Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
title_short Clinical Outcomes of Ezetimibe Plus Statins in Patients With Lower Extremity Artery Disease
title_sort clinical outcomes of ezetimibe plus statins in patients with lower extremity artery disease
topic all-cause mortality
ezetimibe
LEAD
major lower limb amputation
statin
url http://www.sciencedirect.com/science/article/pii/S2772963X25004995
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