BETAMI-DANBLOCK试验与挪威全国心梗人群结局比较
该研究比较BETAMI-DANBLOCK试验参与者与挪威心肌梗死登记(NORMI)队列中血运重建后、LVEF≥40%且无心力衰竭的心梗患者,评估试验代表性。试验参与者更年轻、合并症比例更低,3年全因死亡或心梗绝对风险也低于NORMI队列。将试验人群按NORMI特征加权后,β受体阻滞剂的治疗效果保持一致。
要点
- 试验人群较真实世界NORMI队列更年轻、合并症更少
- NORMI队列3年全因死亡或心梗绝对风险为12.0%,高于试验人群
- 按NORMI特征加权后β受体阻滞剂疗效保持一致
核心结论
- BETAMI和DANBLOCK参与者较NORMI队列更年轻、部分合并症比例更低,全因死亡和心梗风险也更低
- 将试验人群按NORMI队列特征加权后,β受体阻滞剂的治疗效果保持一致
研究设计与样本
- 评估基线特征、估计全因死亡和/或心梗的绝对风险,并通过按NORMI队列特征对BETAMI-DANBLOCK人群加权进行可移植性分析
主要发现
- NORMI队列中位年龄66岁(IQR 57-74),BETAMI和DANBLOCK中位年龄63岁(IQR 55-70)
- NORMI队列糖尿病、既往冠状动脉疾病和LVEF 40-49%的比例高于试验参与者
- 3年随访时,NORMI队列全因死亡或心梗绝对风险为12.0%,BETAMI为7.7%,DANBLOCK为7.8%
- 对应的3年心梗绝对风险分别为NORMI队列6.3%、BETAMI 5.6%、DANBLOCK 4.3%
临床怎么用
- 解读BETAMI-DANBLOCK试验结果时需注意其参与者较真实世界心梗人群更年轻、合并症更少
- β受体阻滞剂疗效在按真实世界特征加权后仍保持稳定,支持结果外推
局限性
- 试验参与者与真实世界NORMI队列在年龄、合并症和LVEF分布上存在差异
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
BACKGROUND AND AIMS: In patients with myocardial infarction (MI), no heart failure, and left ventricular ejection fraction (LVEF) ≥ 40%, the combined BETAMI-DANBLOCK trial showed that beta-blockers reduced the risk of all-cause mortality or major adverse cardiovascular events. This study evaluated the representativeness of the trial. METHODS: Participants in BETAMI (n = 2867) and DANBLOCK (n = 2707) were compared with a cohort of revascularized MI patients with LVEF ≥40%, and no heart failure from the Norwegian Myocardial Infarction Registry (the NORMI cohort)(n = 20 804). Baseline characteristics were evaluated, and absolute risks of all-cause mortality and/or MI were estimated. A transportability analysis was conducted by weighting the BETAMI-DANBLOCK population according to the NORMI cohort. RESULTS: Median age was 66 years (interquartile range [IQR]: 57-74) in the NORMI cohort and 63 years (IQR: 55-70) in BETAMI and DANBLOCK. Patients in the NORMI cohort had a higher prevalence of diabetes, previous coronary artery disease, and LVEF 40-49%, compared with trial participants. At 3-year follow-up, the absolute risk of all-cause mortality or MI was 12.0% in the NORMI cohort, 7.7% in BETAMI, and 7.8% in DANBLOCK. Corresponding risks of MI were 6.3%, 5.6%, and 4.3%, respectively. The treatment effects of beta-blockers were similar when the trial population was weighted according to the characteristics of the NORMI cohort. CONCLUSIONS: Compared with the NORMI cohort, participants in BETAMI and DANBLOCK were younger, had a lower proportion of certain comorbidities, and experienced a lower risk of all-cause mortality and MI. Despite these differences, the effect of beta-blockers remained consistent when the trial population was weighted according to the NORMI cohort.
引用
- Kristensen, Jortveit, Holmager, et al. Outcomes in the BETAMI-DANBLOCK trial compared with a Norwegian nationwide myocardial infarction population. Eur Heart J. 2026. PMID: 42183826. doi:10.1093/eurheartj/ehag348
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。