新兴国家高危猝死患者死亡率的区域差异和危险因素：一项非随机对照试验。
Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial.
机构信息
State Key Laboratory of Cardiovascular Disease, Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No.167 Beilishi Rd, Xicheng District, Beijing, 100037, China.
National Heart Centre Singapore, Outram District, Singapore, Singapore.
出版信息
BMC Med. 2024 Mar 22;22(1):130. doi: 10.1186/s12916-024-03310-5.
BACKGROUND
Comprehensive data on patients at high risk of sudden cardiac death (SCD) in emerging countries are lacking. The aim was to deepen our understanding of the SCD phenotype and identify risk factors for death among patients at high risk of SCD in emerging countries.
METHODS
Patients who met the class I indication for implantable cardioverter-defibrillator (ICD) implantation according to guideline recommendations in 17 countries and regions underrepresented in previous trials were enrolled. Countries were stratified by the WHO regional classification. Patients were or were not implanted with an ICD at their discretion. The outcomes were all-cause mortality and SCD.
RESULTS
We enrolled 4222 patients, and 3889 patients were included in the analysis. The mean follow-up period was 21.6 ± 10.2 months. There were 433 (11.1%) instances of all-cause mortality and 117 (3.0%) cases of SCD. All-cause mortality was highest in primary prevention (PP) patients from Southeast Asia and secondary prevention (SP) patients from the Middle East and Africa. The SCD rates among PP and SP patients were both highest in South Asia. Multivariate Cox regression modelling demonstrated that in addition to the independent predictors identified in previous studies, both geographic region and ICD use were associated with all-cause mortality in patients with high SCD risk. Primary prophylactic ICD implantation was associated with a 36% (HR = 0.64, 95% CI 0.531-0.802, p < 0.0001) lower all-cause mortality risk and an 80% (HR = 0.20, 95% CI = 0.116-0.343, p < 0.0001) lower SCD risk.
CONCLUSIONS
There was significant heterogeneity among patients with high SCD risk in emerging countries. The influences of geographic regions on patient characteristics and outcomes were significant. Improvement in increasing ICD utilization and uptake of guideline-directed medical therapy in emerging countries is urgent.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02099721.
背景
新兴国家中，高危心源性猝死（SCD）患者的综合数据较为缺乏。本研究旨在深入了解 SCD 表型，并确定新兴国家中高危 SCD 患者死亡的危险因素。
方法
根据指南推荐，我们纳入了 17 个在既往试验中代表性不足的国家和地区中符合植入式心脏复律除颤器（ICD）植入 I 类适应证的患者。根据世界卫生组织（WHO）区域分类对国家进行分层。是否植入 ICD 由患者自行决定。结局为全因死亡率和 SCD。
结果
共纳入 4222 例患者，其中 3889 例患者纳入分析。平均随访时间为 21.6±10.2 个月。全因死亡率为 11.1%（433 例），SCD 发生率为 3.0%（117 例）。东南亚的一级预防（PP）患者和中东和非洲的二级预防（SP）患者的全因死亡率最高。南亚的 PP 和 SP 患者的 SCD 发生率均最高。多变量 Cox 回归模型表明，除了既往研究确定的独立预测因素外，地理区域和 ICD 使用与高危 SCD 患者的全因死亡率均相关。初级预防性 ICD 植入与全因死亡率降低 36%相关（HR=0.64，95%CI 0.531-0.802，p<0.0001），与 SCD 风险降低 80%相关（HR=0.20，95%CI 0.116-0.343，p<0.0001）。
结论
新兴国家中高危 SCD 患者存在显著的异质性。地理区域对患者特征和结局的影响显著。提高 ICD 使用率和采用指南指导的药物治疗是当务之急。
试验注册
ClinicalTrials.gov，NCT02099721。
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