Univ. Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, 33000, Bordeaux, France.
Hospital La Conception, Marseille, France.
Cardiovasc Diabetol. 2021 Nov 25;20(1):229. doi: 10.1186/s12933-021-01416-1.
The THEMIS randomized trial compared ticagrelor plus aspirin versus placebo plus aspirin for patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), and without prior myocardial infarction (MI) or stroke. The aim of the study was to quantify the size of the CAD-T2DM population without prior MI or stroke population in a real-world setting, and more specifically populations with similar THEMIS selection criteria (THEMIS-like and THEMIS-PCI-like populations), as well as their risk of major outcomes in current practice.
A 2-year follow-up cohort study included all CAD-T2DM without MI/stroke prevalent patients on January 1st, 2014 in the SNDS French nationwide claims database. The THEMIS-like population concerned those ≥ 50 years of age with similar THEMIS inclusion and exclusion criteria. Prevalence was standardized to the European population. The cumulative incidence function was used to estimate the incidence of clinical outcomes (MI, ischemic stroke, and major bleeding according to the TIMI classification) with death as competing risk, and the Kaplan-Meier estimate for all-cause death and a composite outcome of MI, stroke and all-cause death.
From a population of about 50 million adults, the prevalence of CAD-T2DM without MI/stroke, THEMIS-like and THEMIS-PCI-like populations was respectively at 6.04, 1.50 and 0.27 per 1000 adults, with a mean age of 72.7, 72.3 and 70.9 years and less comorbidities and diabetic complications for the THEMIS-like and THEMIS-PCI-like population. The 2-year cumulative incidence was respectively 1.7%, 1.3% and 1.6% for MI, 1.7%, 1.5% and 1.4% for stroke, 4.8%, 3.1% and 2.9% for major bleeding, 13.6%, 9.7% and 6.8% for all-cause death, and 16.2%, 12.0% and 9.5% for the composite outcome.
THEMIS-like prevalence was estimated at 1.50 per 1,000 adults, representing about a quarter of CAD-T2DM without MI/stroke patients, and 0.27 per 1000 adults for the THEMIS-PCI-like populations. In current French practice, the median age of both these populations was about 5-6 years older than in the THEMIS trial, with a 2-year incidence of major outcomes between two or four time above the ones of the placebo arm of the THEMIS trial using very close definitions. Registration No. EUPAS27402 ( http://www.ENCEPP.eu ).
THEMIS 随机试验比较了替格瑞洛加阿司匹林与安慰剂加阿司匹林用于稳定型冠状动脉疾病和 2 型糖尿病（CAD-T2DM）患者，且无先前的心肌梗死（MI）或中风。该研究的目的是量化在真实世界环境中无先前 MI 或中风的 CAD-T2DM 人群的大小，更具体地说，是具有类似 THEMIS 选择标准的人群（类似 THEMIS 和类似 THEMIS-PCI 人群），以及他们在当前实践中的主要结局风险。
一项为期 2 年的随访队列研究纳入了 2014 年 1 月 1 日 SNDS 法国全国索赔数据库中所有无 MI/中风的 CAD-T2DM 现患患者。类似 THEMIS 的人群包括年龄≥50 岁且具有相似 THEMIS 纳入和排除标准的患者。采用标准化方法将患病率调整为欧洲人口。使用累积发病率函数估计临床结局（根据 TIMI 分类的 MI、缺血性中风和主要出血）的发生率，以死亡为竞争风险，并使用 Kaplan-Meier 估计全因死亡和 MI、中风和全因死亡的复合结局。
在约 5000 万成年人的人群中，无 MI/中风的 CAD-T2DM、类似 THEMIS 和类似 THEMIS-PCI 的人群的患病率分别为每 1000 名成年人 6.04、1.50 和 0.27，平均年龄分别为 72.7、72.3 和 70.9 岁，且类似 THEMIS 和类似 THEMIS-PCI 的人群的合并症和糖尿病并发症较少。MI 的 2 年累积发生率分别为 1.7%、1.3%和 1.6%，中风为 1.7%、1.5%和 1.4%，主要出血为 4.8%、3.1%和 2.9%，全因死亡为 13.6%、9.7%和 6.8%，复合结局为 16.2%、12.0%和 9.5%。
类似 THEMIS 的患病率估计为每 1000 人 1.50，代表无 MI/中风的 CAD-T2DM 患者的四分之一左右，类似 THEMIS-PCI 的人群患病率为每 1000 人 0.27。在当前法国实践中，这两个人群的中位数年龄比 THEMIS 试验中大约大 5-6 岁，使用非常接近的定义，2 年主要结局发生率为安慰剂组的 THEMIS 试验的两倍或四倍。注册号 EUPAS27402（http://www.ENCEPP.eu）。
