Götberg Matthias, Christiansen Evald H, Gudmundsdottir Ingibjörg, Sandhall Lennart, Omerovic Elmir, James Stefan K, Erlinge David, Fröbert Ole
Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Am Heart J. 2015 Nov;170(5):945-50. doi: 10.1016/j.ahj.2015.07.031. Epub 2015 Aug 15.
Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.
DESIGN/METHODS: iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.
The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.
瞬时无波比值（iFR）是一种用于评估冠状动脉狭窄严重程度的新的静息血流动力学指标。iFR采用高频采样来计算舒张期跨冠状动脉病变的压力阶差。该指标已与血流储备分数（FFR）进行对比测试，发现总体分类一致性为80%至85%。这种不一致程度在临床上是否相关尚不清楚。关于iFR的临床结局数据很少。本研究是一项基于注册登记的随机临床试验，这是一种新颖的策略，利用健康质量注册登记作为在线平台进行随机分组、病例记录表填写及随访。
设计/方法：iFR-SWEDEHEART是一项多中心、前瞻性、随机、对照、开放标签的临床试验。2000例患有稳定型心绞痛或急性冠状动脉综合征且有指征进行一个或多个冠状动脉狭窄的生理学指导评估的患者将按1:1随机分为iFR指导组或FFR指导组进行干预。随机分组将在瑞典基于网络的系统中在线进行，该系统用于根据推荐疗法评估的心脏病循证治疗的强化与发展（SWEDEHEART）注册登记。该试验采用非劣效性设计，主要联合终点为12个月时的全因死亡、非致死性心肌梗死和非计划性血运重建。终点事件将通过国家注册登记来确定，并进行中心盲法判定以确保数据质量。
iFR-SWEDEHEART试验是一项基于注册登记的随机临床试验，旨在评估诊断方法iFR与FFR相比的安全性和有效性。
