Division of Cardiology, The Permanente Medical Group, San Francisco, CA, USA.
Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
Eur J Heart Fail. 2019 Mar;21(3):373-381. doi: 10.1002/ejhf.1404. Epub 2019 Jan 30.
The landmark STICH trial found that surgical revascularization compared to medical therapy alone improved survival in patients with heart failure (HF) of ischaemic aetiology and an ejection fraction (EF) ≤ 35%. However, the interaction between the burden of medical co-morbidities and the benefit from surgical revascularization has not been previously described in patients with ischaemic cardiomyopathy.
The STICH trial (ClinicalTrials.gov Identifier: NCT00023595) enrolled patients ≥ 18 years of age with coronary artery disease amenable to coronary artery bypass grafting (CABG) and an EF ≤ 35%. Eligible participants were randomly assigned 1:1 to receive medical therapy (MED) (n = 602) or MED/CABG (n = 610). A modified Charlson co-morbidity index (CCI) based on the availability of data and study definitions was calculated by summing the weighted points for all co-morbid conditions. Patients were divided into mild/moderate (CCI 1-4) and severe (CCI ≥ 5) co-morbidity. Cox proportional hazards models were used to evaluate the association between CCI and outcomes and the interaction between severity of co-morbidity and treatment effect. The study population included 349 patients (29%) with a mild/moderate CCI score and 863 patients (71%) with a severe CCI score. Patients with a severe CCI score had greater functional limitations based on 6-min walk test and impairments in health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire. A total of 161 patients (Kaplan-Meier rate = 50%) with a mild/moderate CCI score and 579 patients (Kaplan-Meier rate = 69%) with a severe CCI score died over a median follow-up of 9.8 years. After adjusting for baseline confounders, patients with a severe CCI score were at higher risk for all-cause mortality (hazard ratio 1.44, 95% confidence interval 1.19-1.74; P < 0.001). There was no interaction between CCI score and treatment effect on survival (P = 0.756).
More than 70% of patients had a severe burden of medical co-morbidities at baseline, which was independently associated with increased risk of death. There was not a differential benefit of surgical revascularization with respect to survival based on severity of co-morbidity.
具有里程碑意义的 STICH 试验发现,与单纯药物治疗相比,手术血运重建可改善缺血性病因和射血分数(EF)≤35%的心力衰竭(HF)患者的生存率。然而,以前尚未在缺血性心肌病患者中描述过医疗合并症负担与手术血运重建获益之间的相互作用。
STICH 试验(ClinicalTrials.gov 标识符:NCT00023595)纳入了年龄≥18 岁、适合冠状动脉旁路移植术(CABG)且 EF≤35%的冠状动脉疾病患者。合格的参与者被随机 1:1 分配接受药物治疗(MED)(n=602)或 MED/CABG(n=610)。根据数据的可用性和研究定义,计算了改良的 Charlson 合并症指数(CCI),其方法是将所有合并症的加权点数相加。患者被分为轻度/中度(CCI 1-4)和重度(CCI≥5)合并症。Cox 比例风险模型用于评估 CCI 与结局之间的关联以及合并症严重程度与治疗效果之间的相互作用。研究人群包括 349 名(29%)轻度/中度 CCI 评分患者和 863 名(71%)重度 CCI 评分患者。CCI 评分较高的患者,6 分钟步行试验的功能受限更大,堪萨斯城心肌病问卷评估的健康相关生活质量受损更严重。在中位随访 9.8 年后,共有 161 名(Kaplan-Meier 率=50%)轻度/中度 CCI 评分患者和 579 名(Kaplan-Meier 率=69%)重度 CCI 评分患者死亡。在校正基线混杂因素后,CCI 评分较高的患者全因死亡率更高(风险比 1.44,95%置信区间 1.19-1.74;P<0.001)。CCI 评分与治疗效果对生存的交互作用无统计学意义(P=0.756)。
超过 70%的患者在基线时存在严重的医疗合并症负担,这与死亡风险增加独立相关。手术血运重建在生存方面没有因合并症严重程度的不同而获益。