Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients

Completed

• Conditions: Major Adverse Cardiovascular Events; Liver Transplantation
• Interventions: Drug: Preoperative Statin Use

• Registration Number: NCT07089589
• Lead Sponsor: Asan Medical Center

Brief Summary

The goal of this observational study is to determine whether preoperative statin use reduces major adverse cardiovascular events or other complications after liver transplantation. The main question it aims to answer is:

Does preoperative statin use reduce major adverse cardiovascular events or other complications after liver transplantation? The records of participants who already took statins before liver transplantation will be reviewed.

Detailed Description

Cardiovascular complications have emerged as a leading cause of early postoperative death following liver transplantation (LT), accounting for over 40% of early deaths. As a result, preventing postoperative cardiac complications has become a critical concern in the management of LT recipients.

Statin therapy has been suggested to improve perioperative and long-term outcomes in various surgical populations, primarily through LDL cholesterol reduction as well as pleiotropic effects, such as enhanced endothelial function and anti-inflammatory actions. However, evidence specifically examining the impact of preoperative statin therapy on cardiovascular outcomes after LT remains limited, highlighting the need for further research in this population.

This study aimed to address the current knowledge gap by investigating the association between preoperative statin use and the incidence of major adverse cardiovascular events within 30 days after liver transplantation in liver transplant recipients. Secondary outcomes included overall mortality, early allograft dysfunction, acute kidney injury, length of stay in the intensive care unit, duration of mechanical ventilation, and myocardial injury after non-cardiac surgery within 3 and 30 days after transplantation.

Study Timeline

• Study Start: 2008-01-02
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-19
• Status Verified: 2025-07
• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6006

Inclusion Criteria

• Adult patients aged ≥18 years who underwent liver transplantation

Exclusion Criteria

• Patients who underwent liver re-transplantation
• Patients with preoperative acute-on-chronic liver failure (ACLF)
• Patients with preoperative fulminant hepatic failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statin group	Preoperative Statin Use	Patients who received preoperative statin therapy

Primary Outcome Measures

Name	Time	Method
30-day Major Adverse Cardiovascular Events	30 days after liver transplantation	The composite of cardiovascular death, heart failure, myocardial infarction, atrial fibrillation, ventricular arrhythmia, ischemic electrocardiogram changes (ST-segment depression or elevation) with chest tightness, pulmonary embolism, and stroke

Secondary Outcome Measures

Name	Time	Method
Myocardial Injury after Non-Cardiac Surgery (MINS)	Within 3 days and 30 days after liver transplantation	The incidence of MINS within 3 and 30 days. Defined as a postoperative cardiac TnI level above 40 pg/mL before November 2021, and above 60 pg/mL thereafter, based on the 99th percentile upper reference limit for high-sensitivity TnI assays established in the Korean population
Acute Kidney Injury	Within 7 days after liver transplantation	Occurrence of acute kidney injury within 7 days post-transplantation, diagnosed according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Overall Mortality	From the date of liver transplantation to May 19, 2025	Death from any cause after liver transplantation
Early Allograft Dysfunction	Within 7 days after liver transplantation	Defined as serum bilirubin \>10 mg/dL or international normalized ratio (INR) \>1.6 on postoperative day (POD) 7, or alanine/aspartate aminotransferases \>2000 IU/L within 7 days after transplantation
Intensive Care Unit Length of Stay	From the date of liver transplantation until intensive care unit discharge, up to 600 days	Total duration (days) of intensive care unit stay after liver transplantation
Mechanical Ventilation Duration	From the date of transplantation until discontinuation of mechanical ventilation, up to 600 days	Duration (days) of postoperative mechanical ventilation following liver transplantation

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of