Association of Annual LDL Cholesterol Testing With Cardiovascular Outcomes Among Cancer Survivors: A Sequential Target Trial Emulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,294,726
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events
研究概览
简要总结
This observational study will evaluate whether annual low-density lipoprotein cholesterol (LDL-C) testing is associated with improved cardiovascular preventive care and a lower risk of cardiovascular events among cancer survivors.
The study will use nationwide health insurance and cancer registry data from Korea. Adults with a history of cancer who are alive at least 1 year after cancer diagnosis, have no prior major cardiovascular disease, and are not receiving statin therapy at the start of an eligible study period will be included.
The investigators will compare cancer survivors who undergo LDL-C testing with similar cancer survivors who do not undergo LDL-C testing. Participants will not be assigned to receive testing or treatment by the investigators. Instead, routinely collected health care data will be analyzed.
The main outcome will be major adverse cardiovascular and cerebrovascular events, including cardiovascular death, myocardial infarction, stroke, and coronary revascularization. The study will also examine whether LDL-C testing is associated with subsequent initiation of statin therapy.
The findings may help determine whether routine lipid testing can support cardiovascular disease prevention as part of long-term survivorship care for people with cancer.
详细描述
Cardiovascular disease is an important cause of long-term morbidity and mortality among cancer survivors. Current cardio-oncology and survivorship guidelines recommend periodic assessment of cardiovascular risk factors, including lipid profiles. However, limited evidence is available regarding whether routine LDL-C testing leads to greater initiation of preventive therapy or fewer cardiovascular events in cancer survivors.
This nationwide observational cohort study will evaluate the association between annual LDL-C testing and cardiovascular outcomes among statin-naive cancer survivors. The study will use routinely collected administrative health insurance and cancer registry data from Korea.
A sequential target trial emulation design will be used. Eligibility will be reassessed at a series of annual trial baselines beginning 1 year after cancer diagnosis. At each trial baseline, individuals will be eligible if they are alive, remain under observation, have no history of cardiovascular disease, myocardial infarction, stroke, familial hypercholesterolemia, percutaneous coronary intervention, or coronary artery bypass grafting, and are not receiving statin therapy. The same individual may contribute to more than one annual emulated trial if all eligibility criteria continue to be met.
At each eligible trial baseline, participants will be classified according to whether they undergo LDL-C testing. Participants in the active testing group will be compared with participants in the inactive testing group. Propensity scores will be estimated using demographic and clinical variables, including age, sex, cancer type, cancer diagnosis year, cancer stage, hypertension, diabetes mellitus, and dyslipidemia. One-to-one propensity score matching will be performed within each emulated trial.
The primary outcome will be major adverse cardiovascular and cerebrovascular events, defined as a composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization. Secondary outcomes will include the individual components of the composite outcome and initiation of statin therapy within 1 year after the trial baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a diagnosis of cancer recorded in the nationwide cancer registry and health insurance database
- •Alive and under observation at least 1 year after the initial cancer diagnosis
- •Eligible for entry at an annual emulated trial baseline
- •Not receiving statin therapy at the corresponding trial baseline
- •Available information on age, sex, cancer type, year of cancer diagnosis, cancer stage, diabetes mellitus, hypertension, and dyslipidemia
- •Continuous eligibility for outcome ascertainment in the national health insurance database
排除标准
- •History of cardiovascular disease before the corresponding trial baseline
- •History of myocardial infarction or stroke before the corresponding trial baseline
- •History of familial hypercholesterolemia
- •History of percutaneous coronary intervention or coronary artery bypass grafting
- •Use of statin therapy before or at the corresponding trial baseline
- •Missing information required to determine eligibility, exposure status, or prespecified baseline covariates
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events
时间窗: From each annual emulated trial baseline through up to 6 years of follow-up
First occurrence of a composite outcome comprising cardiovascular death, myocardial infarction, stroke, or coronary revascularization. Cardiovascular outcomes will be identified using prespecified diagnosis, procedure, and mortality records from nationwide health insurance and linked registry data. Only the first event occurring after each annual emulated trial baseline will be counted for the primary analysis.
次要结局
- Initiation of Statin Therapy(Within 1 year after each annual emulated trial baseline)
研究者
Danbee Kang
Associate Professor
Samsung Medical Center