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Outcomes of Participants With Diabetes in the ISCHEMIA Trials
Circulation ( IF 37.8 ) Pub Date : 2021-09-15 , DOI: 10.1161/circulationaha.121.054439
Jonathan D Newman 1 , Rebecca Anthopolos 1 , G B John Mancini 2 , Sripal Bangalore 1 , Harmony R Reynolds 1 , Dennis F Kunichoff 1 , Roxy Senior 3 , Jesus Peteiro 4 , Balram Bhargava 5 , Pallav Garg 6 , Jorge Escobedo 7 , Rolf Doerr 8 , Tomasz Mazurek 9 , Jose Gonzalez-Juanatey 10 , Grzegorz Gajos 11 , Carlo Briguori 12 , Hong Cheng 13 , Andras Vertes 14 , Sandeep Mahajan 5 , Luis A Guzman 15 , Matyas Keltai 16 , Aldo P Maggioni 17 , Gregg W Stone 18 , Jeffrey S Berger 1 , Yves D Rosenberg 19 , William E Boden 20 , Bernard R Chaitman 21 , Jerome L Fleg 19 , Judith S Hochman , David J Maron 22
Affiliation  

Background:Among patients with diabetes and chronic coronary disease, it is unclear if invasive management improves outcomes when added to medical therapy.Methods:The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trials (ie, ISCHEMIA and ISCHEMIA–Chronic Kidney Disease) randomized chronic coronary disease patients to an invasive (medical therapy + angiography and revascularization if feasible) or a conservative approach (medical therapy alone with revascularization if medical therapy failed). Cohorts were combined after no trial-specific effects were observed. Diabetes was defined by history, hemoglobin A1c ≥6.5%, or use of glucose-lowering medication. The primary outcome was all-cause death or myocardial infarction (MI). Heterogeneity of effect of invasive management on death or MI was evaluated using a Bayesian approach to protect against random high or low estimates of treatment effect for patients with versus without diabetes and for diabetes subgroups of clinical (female sex and insulin use) and anatomic features (coronary artery disease severity or left ventricular function).Results:Of 5900 participants with complete baseline data, the median age was 64 years (interquartile range, 57–70), 24% were female, and the median estimated glomerular filtration was 80 mL·min−1·1.73−2 (interquartile range, 64–95). Among the 2553 (43%) of participants with diabetes, the median percent hemoglobin A1c was 7% (interquartile range, 7–8), and 30% were insulin-treated. Participants with diabetes had a 49% increased hazard of death or MI (hazard ratio, 1.49 [95% CI, 1.31–1.70]; P<0.001). At median 3.1-year follow-up the adjusted event-free survival was 0.54 (95% bootstrapped CI, 0.48–0.60) and 0.66 (95% bootstrapped CI, 0.61–0.71) for patients with diabetes versus without diabetes, respectively, with a 12% (95% bootstrapped CI, 4%–20%) absolute decrease in event-free survival among participants with diabetes. Female and male patients with insulin-treated diabetes had an adjusted event-free survival of 0.52 (95% bootstrapped CI, 0.42–0.56) and 0.49 (95% bootstrapped CI, 0.42–0.56), respectively. There was no difference in death or MI between strategies for patients with diabetes versus without diabetes, or for clinical (female sex or insulin use) or anatomic features (coronary artery disease severity or left ventricular function) of patients with diabetes.Conclusions:Despite higher risk for death or MI, chronic coronary disease patients with diabetes did not derive incremental benefit from routine invasive management compared with initial medical therapy alone.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

中文翻译:

ISCHEMIA 试验中糖尿病患者的结果

背景:在糖尿病和慢性冠心病患者中,尚不清楚在药物治疗中加入侵入性治疗是否能改善预后。方法:ISCHEMIA(国际医学和侵入性方法的健康有效性比较研究)试验(即 ISCHEMIA 和 ISCHEMIA-慢性肾脏病)将慢性冠心病患者随机分配到侵入性(药物治疗+血管造影和血运重建,如果可行)或保守治疗(单独药物治疗,如果药物治疗失败,则血运重建)。在未观察到试验特异性效应后,将队列合并。糖尿病的定义是病史、血红蛋白 A1c ≥6.5% 或使用降糖药物。主要结局是全因死亡或心肌梗死(MI)。-1 ·1.73 -2(四分位距,64–95)。在 2553 名 (43%) 糖尿病参与者中,血红蛋白 A1c 百分比中位数为 7%(四分位距,7-8),30% 接受了胰岛素治疗。糖尿病患者的死亡或心肌梗死风险增加 49%(风险比,1.49 [95% CI,1.31–1.70];P<0.001)。在中位 3.1 年的随访中,糖尿病患者与非糖尿病患者的调整后无事件生存期分别为 0.54(95% 自举 CI,0.48-0.60)和 0.66(95% 自举 CI,0.61-0.71)。糖尿病参与者的无事件生存率绝对降低 12%(95% 自举 CI,4%–20%)。接受胰岛素治疗的糖尿病女性和男性患者的调整后无事件生存期分别为 0.52(95% 自举 CI,0.42-0.56)和 0.49(95% 自举 CI,0.42-0.56)。糖尿病患者与非糖尿病患者的策略或糖尿病患者的临床(女性或胰岛素使用)或解剖特征(冠状动脉疾病严重程度或左心室功能)的策略之间的死亡或 MI 没有差异。结论:尽管更高死亡或心肌梗死的风险,与单独的初始药物治疗相比,患有糖尿病的慢性冠心病患者并未从常规侵入性管理中获得更多益处。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT01471522。
更新日期:2021-10-26
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