Cardiology Department, Health Research Institute of the Balearic Islands (IdISBa), Hospital Universitari Son Espases, Palma, Spain.
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Clin Res Cardiol. 2021 Oct;110(10):1612-1624. doi: 10.1007/s00392-021-01859-2. Epub 2021 Apr 30.
Women, older patients and non-White ethnic groups experience a substantial proportion of acute coronary syndromes (ACS), although they have been historically underrepresented in ACS randomized clinical trials (RCTs). To assess the influence of sex, age and race on major adverse cardiovascular events (MACE) and on heart failure events, we studied patients with type 2 diabetes in a large post-ACS trial (EXAMINE).
Differences in baseline characteristics and the respective composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE) and cardiovascular death or heart failure hospitalization (HF events) were evaluated by subgroups in a cohort of post-ACS patients with diabetes, using unadjusted and adjusted Cox regression modelling.
The EXAMINE trial enrolled 5380 patients with 35% aged > 65, 32% female and 27% non-White. The risk of MACE was higher in non-White compared to White patients after adjustment for potential confounding (HR = 1.35; 95% CI 1.04-1.75), but there were no significant differences by sex and age (HR = 1.03; 95% CI 0.87-1.22 for women; HR = 1.14; 95% CI 0.96-1.35 for patients ≥ 65 years). The risk of HF events was higher in non-White patients (HR = 1.56; 95% CI 1.13-2.14), and in patients aged > 65 (HR = 1.33; 95% CI 1.07-1.66) and nominally so in women (HR = 1.23; 95% CI 0.99-1.52). The additive risk of each demographic factor (women, older age and non-White race) was greater for HF events in comparison with MACE. Moreover, non-White elderly patients consistently had poorer prognosis regardless of sex.
Older adults, women and non-White patients with diabetes who are post-ACS are often underrepresented in RCTs. The risk for HF events was higher in older and non-White patients, with a trend towards significance in women, whereas only non-White patients (and not women and older patients) were at higher risk for MACE. Future trials should enrich enrollment of these persons at risk.
女性、老年患者和非白种人群体在急性冠脉综合征（ACS）中占很大比例，尽管他们在 ACS 随机临床试验（RCT）中历来代表性不足。为了评估性别、年龄和种族对主要不良心血管事件（MACE）和心力衰竭事件的影响，我们在一项大型 ACS 后试验（EXAMINE）中研究了 2 型糖尿病患者。
使用未经调整和调整后的 Cox 回归模型，根据亚组评估了 ACS 后糖尿病患者队列的基线特征和心血管死亡、非致命性心肌梗死或非致命性卒中（MACE）以及心血管死亡或心力衰竭住院（HF 事件）的复合终点差异。
EXAMINE 试验纳入了 5380 名患者，其中 35%年龄>65 岁，32%为女性，27%为非白种人。在调整潜在混杂因素后，非白种人发生 MACE 的风险高于白种人（HR=1.35；95%CI 1.04-1.75），但性别和年龄无显著差异（HR=1.03；95%CI 0.87-1.22 为女性；HR=1.14；95%CI 0.96-1.35 为年龄≥65 岁患者）。非白种人患者发生 HF 事件的风险更高（HR=1.56；95%CI 1.13-2.14），年龄>65 岁的患者风险更高（HR=1.33；95%CI 1.07-1.66），女性风险略高（HR=1.23；95%CI 0.99-1.52）。与 MACE 相比，每个人口统计学因素（女性、年龄较大和非白种人种族）的附加风险对 HF 事件的影响更大。此外，无论性别如何，年龄较大的非白种人 ACS 后患者的预后均较差。
ACS 后患有糖尿病的老年患者、女性和非白种人在 RCT 中往往代表性不足。年龄较大和非白种人患者发生 HF 事件的风险更高，女性患者有发生趋势，但只有非白种人患者（而非女性和老年患者）发生 MACE 的风险更高。未来的试验应增加这些高危人群的入组。
