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加澳随机筛选肾移植候选者冠心病试验-CARSK 研究试验方案。

Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study.

出版信息

Am Heart J. 2019 Aug;214:175-183. doi: 10.1016/j.ahj.2019.05.008. Epub 2019 May 22.

Abstract

Transplantation is the preferred treatment for patients with kidney failure, but the need exceeds the supply of transplantable kidneys, and patients routinely wait >5 years on dialysis for a transplant. Coronary artery disease (CAD) is common in kidney failure and can exclude patients from transplantation or result in death before or after transplantation. Screening asymptomatic patients for CAD using noninvasive tests prior to wait-listing and at regular intervals (ie, annually) after wait-listing until transplantation is the established standard of care and is justified by the need to avoid adverse patient outcomes and loss of organs. Patients with abnormal screening tests undergo coronary angiography, and those with critical stenoses are revascularized. Screening is potentially harmful because patients may be excluded or delayed from transplantation, and complications after revascularization are more frequent in this population. CARSK will test the hypothesis that eliminating screening tests for occult CAD after wait-listing is not inferior to regular screening for the prevention of major adverse cardiac events defined as the composite of cardiovascular death, nonfatal myocardial infarction, urgent revascularization, and hospitalization for unstable angina. Secondary outcomes include the transplant rate, safety measures, and the cost-effectiveness of screening. Enrolment of 3,306 patients over 3 years is required, with patients followed for up to 5 years during wait-listing and for 1 year after transplantation. By validating or refuting the use of screening tests during wait-listing, CARSK will ensure judicious use of health resources and optimal patient outcomes.

摘要

移植是肾衰竭患者的首选治疗方法,但可供移植的肾脏数量供不应求,患者通常需要在透析上等待 >5 年才能进行移植。冠状动脉疾病(CAD)在肾衰竭中很常见,可能会使患者被排除在移植之外,或导致患者在移植前或移植后死亡。在等待名单上列出之前和之后定期(即每年)使用非侵入性测试对无症状患者进行 CAD 筛查,是既定的护理标准,这是为了避免不良的患者结果和器官损失。对筛查异常的患者进行冠状动脉造影,如果存在严重狭窄则进行血运重建。筛查可能会带来危害,因为患者可能会被排除或延迟进行移植,而且在这个人群中,血运重建后的并发症更为常见。CARSK 将检验以下假设,即在等待名单上列出后消除隐匿性 CAD 的筛查测试不会劣于常规筛查,以预防主要不良心脏事件,定义为心血管死亡、非致死性心肌梗死、紧急血运重建和不稳定型心绞痛住院的综合结果。次要结果包括移植率、安全措施以及筛查的成本效益。需要在 3 年内招募 3306 名患者,患者在等待名单上的随访时间最长可达 5 年,移植后随访时间为 1 年。通过验证或反驳在等待名单期间进行筛查测试的使用,CARSK 将确保明智地利用卫生资源和实现最佳的患者结果。

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