Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
Open Heart. 2021 Feb;8(1). doi: 10.1136/openhrt-2020-001453.
Coronary artery bypass graft (CABG) patients are under-represented in acute coronary syndrome (ACS) trials. We compared characteristics and outcomes for patients who did and did not participate in a randomised trial of invasive versus non-invasive management (CABG-ACS).
ACS patients with prior CABG in four hospitals were randomised to invasive or non-invasive management. Non-randomised patients entered a registry. Primary efficacy (composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction (MI), heart failure) and safety outcomes (composite of bleeding, stroke, procedure-related MI, worsening renal function) were independently adjudicated.
Of 217 patients screened, 84 (39%) screenfailed, of whom 24 (29%) did not consent and 60 (71%) were ineligible. Of 133 (61%) eligible, 60 (mean±SD age, 71±9 years, 72% male) entered the trial and 73 (age, 72±10 years, 73% male) entered a registry (preferences: physician (79%), patient (38%), both (21%)).Compared with trial participants, registry patients had more valve disease, lower haemoglobin, worse New York Heart Association class and higher frailty.At baseline, invasive management was performed in 52% and 49% trial and registry patients, respectively, of whom 32% and 36% had percutaneous coronary intervention at baseline, respectively (p=0.800). After 2 years follow-up (694 (median, IQR 558-841) days), primary efficacy (43% trial vs 49% registry (HR 1.14, 95% CI 0.69 to 1.89)) and safety outcomes (28% trial vs 22% registry (HR 0.74, 95% CI 0.37 to 1.46)) were similar. EuroQol was lower in registry patients at 1 year.
Compared with trial participants, registry participants had excess morbidity, but longer-term outcomes were similar.
NCT01895751.
在急性冠状动脉综合征（ACS）试验中，冠状动脉旁路移植术（CABG）患者的代表性不足。我们比较了接受介入与非介入治疗（CABG-ACS）随机试验和未接受随机试验的患者的特征和结局。
四家医院的既往 CABG 的 ACS 患者被随机分配至介入或非介入管理。非随机患者进入登记处。主要疗效（全因死亡率、复发性缺血/心绞痛再住院、心肌梗死 (MI)、心力衰竭的复合终点）和安全性结局（出血、卒中和手术相关 MI、肾功能恶化的复合终点）独立判断。
在 217 名筛查患者中，84 名（39%）筛查失败，其中 24 名（29%）不同意，60 名（71%）不符合条件。在 133 名（61%）符合条件的患者中，60 名（平均年龄 ±标准差，71±9 岁，72%男性）进入试验，73 名（72±10 岁，73%男性）进入登记处（偏好：医生（79%），患者（38%），两者（21%））。与试验参与者相比，登记处患者的瓣膜疾病更多，血红蛋白水平更低，纽约心脏协会（NYHA）心功能分级更差，衰弱程度更高。基线时，分别有 52%和 49%的试验和登记处患者接受了介入治疗，其中分别有 32%和 36%的患者在基线时接受了经皮冠状动脉介入治疗（p=0.800）。在 2 年随访后（中位数为 694 天[IQR，558-841]），主要疗效（试验组为 43%，登记组为 49%（HR 1.14，95%CI 0.69 至 1.89））和安全性结局（试验组为 28%，登记组为 22%（HR 0.74，95%CI 0.37 至 1.46））相似。登记处患者在 1 年时的 EuroQol 评分较低。
与试验参与者相比，登记处参与者的发病率更高，但长期结局相似。
NCT01895751。
