Colleran Roisin, Douglas Pamela S, Hadamitzky Martin, Gutberlet Matthias, Lehmkuhl Lukas, Foldyna Borek, Woinke Michael, Hink Ulrich, Nadjiri Jonathan, Wilk Alan, Wang Furong, Pontone Gianluca, Hlatky Mark A, Rogers Campbell, Byrne Robert A
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Open Heart. 2017 Mar 22;4(1):e000526. doi: 10.1136/openhrt-2016-000526. eCollection 2017.
Diagnostic evaluation practices for suspected coronary artery disease (CAD) may vary between countries. Our objective was to compare a CT-derived fractional flow reserve (FFR) diagnostic strategy with usual care in patients with planned invasive coronary angiography (ICA) enrolled in the PLATFORM (Prospective Longitudinal Trial of FFR: Outcome and Resource Impacts) study at German sites.
Patients were divided into two consecutive observational cohorts, receiving either usual care or CT angiography (CTA)/FFR. The primary endpoint was the percentage of patients planned for ICA, with no obstructive CAD on ICA within 90 days. Secondary endpoints included death, myocardial infarction, unstable angina, hospitalisation leading to unplanned revascularisation, cumulative radiation exposure, estimated medical costs and quality of life (QOL) at 1 year.
116 patients were included. The primary endpoint occurred in 4 of the 52 patients (7.7%) in the CTA/FFR group and in 55 of the 64 patients (85.9%) in the usual care group (risk difference 78.2%, 95% CI 67.1% to 89.4%, p<0.001). ICA was cancelled in 40 of the 52 patients (77%) who underwent CTA/FFR. Clinical event rates were low overall. The mean radiation exposure was lower in the FFR versus the usual care group (7.28 vs 9.80 mSv, p<0.001). Mean estimated medical costs were €4217 (CTA/FFR) versus €6894 (usual care), p<0.001. Improvement in QOL (EQ-5D score) was greater in the FFR (+0.09 units) versus the usual care cohort (+0.03 units), p=0.04.
In patients with suspected CAD planned for ICA at German sites, initial CTA/FFR compared with usual care was associated with a markedly reduced rate of ICA showing no obstructive CAD, lower cumulative radiation exposure and estimated costs and greater improvement in QOL.
不同国家对疑似冠心病(CAD)的诊断评估方法可能存在差异。我们的目的是在德国参与PLATFORM(FFR前瞻性纵向试验:结果与资源影响)研究的计划进行有创冠状动脉造影(ICA)的患者中,比较CT衍生的血流储备分数(FFR)诊断策略与常规治疗。
患者被分为两个连续的观察队列,分别接受常规治疗或CT血管造影(CTA)/FFR。主要终点是计划进行ICA的患者中,90天内ICA显示无阻塞性CAD的患者百分比。次要终点包括死亡、心肌梗死、不稳定型心绞痛、导致非计划血管重建的住院治疗、累积辐射暴露、估计医疗费用以及1年时的生活质量(QOL)。
共纳入116例患者。CTA/FFR组52例患者中有4例(7.7%)达到主要终点,常规治疗组64例患者中有55例(85.9%)达到主要终点(风险差异78.2%,95%CI 67.1%至89.4%,p<0.001)。接受CTA/FFR的52例患者中有40例(77%)取消了ICA。总体临床事件发生率较低。FFR组的平均辐射暴露低于常规治疗组(7.28对9.80 mSv,p<0.001)。平均估计医疗费用为4217欧元(CTA/FFR)对6894欧元(常规治疗),p<0.001。FFR组的QOL改善(EQ-5D评分)大于常规治疗队列(分别为+0.09单位和+0.03单位,p=0.04)。
在德国计划进行ICA的疑似CAD患者中,与常规治疗相比,初始CTA/FFR与显示无阻塞性CAD的ICA发生率显著降低、累积辐射暴露和估计费用降低以及QOL改善更大相关。