Objective: To compare the expected population impact of benefit and risk of aspirin treatment strategies for the primary prevention of cardiovascular diseases recommended by different guidelines in the Chinese Electronic Health Records Research in Yinzhou (CHERRY) study.
Methods: A decision-analytic Markov model was used to simulate and compare different strategies of aspirin treatment, including: Strategy ①: Aspirin treatment for Chinese adults aged 40-69 years with a high 10-year cardiovascular risk, recommended by the 2020 Chinese Guideline on the Primary Prevention of Cardiovascular Diseases; Strategy ②: Aspirin treatment for Chinese adults aged 40-59 years with a high 10-year cardiovascular risk, recommended by the 2022 United States Preventive Services Task Force Recommendation Statement on Aspirin Use to Prevent Cardiovascular Disease; Strategy ③: Aspirin treatment for Chinese adults aged 40-69 years with a high 10-year cardiovascular risk and blood pressure well-controlled (< 150/90 mmHg), recommended by the 2019 Guideline on the Assessment and Management of Cardio-vascular Risk in China. The high 10-year cardiovascular risk was defined as the 10-year predicted risk over 10% based on the 2019 World Health Organization non-laboratory model. The Markov model simulated different strategies for ten years (cycles) with parameters mainly from the CHERRY study or published literature. Quality-adjusted life year (QALY) and the number needed to treat (NNT) for each ischemic event (including myocardial infarction and ischemic stroke) were calculated to assess the effectiveness of the different strategies. The number needed to harm (NNH) for each bleeding event (including hemorrhagic stroke and gastrointestinal bleeding) was calculated to assess the safety. The NNT for each net benefit (i.e., the difference of the number of ischemic events could be prevented and the number of bleeding events would be added) was also calculated. One-way sensitivity analysis on the uncertainty of the incidence rate of cardiovascular diseases and probabilistic sensitivity analysis on the uncertainty of hazard ratios of interventions were conducted.
Results: A total of 212 153 Chinese adults, were included in this study. The number of people who were recommended for aspirin treatment Strategies ①-③ was 34 235, 2 813, and 25 111, respectively. The Strategy ③ could gain the most QALY of 403 [95% uncertainty interval (UI): 222-511] years. Compared with Strategy ①, Strategy ③ had similar efficiency but better safety, with the extra NNT of 4 (95%UI: 3-4) and NNH of 39 (95%UI: 19-132). The NNT per net benefit was 131 (95%UI: 102-239) for Strategy ①, 256 (95%UI: 181-737) for Strategy ②, and 132 (95%UI: 104-232) for Strategy ③, making Strategy ③ the most favorable option with a better QALY and safety, along with similar efficiency in terms of net benefit. The results were consistent in the sensitivity analyses.
Conclusion: The aspirin treatment strategies recommended by the updated guidelines on the primary prevention of cardiovascular diseases showed a net benefit for high-risk Chinese adults from developed areas. However, to balance effectiveness and safety, aspirin is suggested to be used for primary prevention of cardiovascular diseases with consideration for blood pressure control, resulting in better intervention efficiency.
目的: 在中国鄞州电子健康档案研究(Chinese Electronic Health Records Research in Yinzhou，CHERRY)中，比较实施不同指南推荐的阿司匹林用于心血管病一级预防策略预期的获益与风险。
方法: 采用马尔可夫(Markov)模型模拟所比较的不同策略：策略①：对40~69岁心血管病高风险人群使用低剂量阿司匹林干预(2020年《中国心血管病一级预防指南》)；策略②：对40~59岁心血管病高风险人群使用低剂量阿司匹林干预(2022年美国预防服务工作组《阿司匹林用于心血管病一级预防的推荐声明》)；策略③：对40~69岁心血管病高风险且基线血压控制良好(150/90 mmHg以下)的人群使用低剂量阿司匹林干预(2019年《中国心血管病风险评估和管理指南》)。循环周期设为1年，模拟10年，获益指标包括增加的质量调整生命年(quality-adjusted life year, QALY)和每预防一例缺血性事件的需治疗人数(number needed to treat, NNT)，风险指标包括每增加一例出血性事件的需应对危害人数(number needed to harm, NNH)，计算人群净获益(可预防的缺血性事件数减去增加的出血性事件数)及其NNT。
结果: 共纳入212 153名研究对象，采用策略①~③进行阿司匹林干预的人数分别为34 235、2 813和25 111。策略③预期增加的QALY最多，为403[95%不确定性区间(uncertainty interval, UI)：222~511]年，其获益指标的NNT仅比策略①增加了4(95%UI：3~4)人，但风险指标的NNH增加了39(95%UI：19~132)人，显示策略③的安全性更好。三种策略净获益的NNT分别为131(95%UI：102~239)人、256(95%UI：181~737)人和132(95%UI：104~232)人，在净获益效率相似时，QALY和安全性更好的策略③具有优势。
结论: 采用三种策略在CHERRY人群中均能获得净获益，相比之下考虑血压控制水平的策略可兼顾效果获益与安全性风险，并获得较好的干预效率。
Keywords: Aspirin; Cardiovascular diseases; Markov model; Primary prevention.