Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study.
Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study.
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DOI：
10.1093/eurheartj/ehv444
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发表时间：
2015-12-14
影响因子：
39.3
通讯作者：
PLATFORM Investigators
中科院分区：
文献类型：
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作者：
Douglas PS;Pontone G;Hlatky MA;Patel MR;Norgaard BL;Byrne RA;Curzen N;Purcell I;Gutberlet M;Rioufol G;Hink U;Schuchlenz HW;Feuchtner G;Gilard M;Andreini D;Jensen JM;Hadamitzky M;Chiswell K;Cyr D;Wilk A;Wang F;Rogers C;De Bruyne B;PLATFORM Investigators
在有症状的疑似冠状动脉疾病（CAD）患者中，与功能检查相比，计算机断层血管造影（CTA）改善了有创冠状动脉造影（ICA）患者的选择。CTA （FFRCT）测量部分流量储备的影响尚不清楚。在11个地点，584例新发胸痛患者被前瞻性地分配接受常规检查（n = 287）或CTA/FFRCT （n = 297）。测试解释和护理决定由临床护理团队做出。主要终点是计划进行ICA的患者在90天内未发现明显阻塞性CAD（核心实验室定量分析未发现狭窄≥50%或侵袭性FFR < 0.80）的百分比。次要终点包括死亡、心肌梗死和计划外血运重建术被独立和盲目地判定。受试者平均年龄61±11岁，女性占40%，梗阻性CAD的平均检前概率为49±17%。在计划进行ICA的患者中（FFRCT引导= 193例，常规护理= 187例），CTA/FFRCT组中24例（12%）和常规护理组中137例（73%）在ICA中未发现阻塞性CAD（风险差61%，95%置信区间53-69，P< 0.0001），平均累积辐射暴露相似（9.9 vs. 9.4 mSv, P = 0.20）。在接受CTA/FFRCT结果后，61%的患者取消了有创冠状动脉造影。在进行非侵入性检查的患者中，ICA未发现阻塞性CAD的比例分别为13% （CTA/FFRCT）和6%（常规护理；P = 0.95）。常规护理组和CTA/FFRCT组90天内的临床事件发生率较低。计算机断层血管造影/ CTA分流血流储备是ICA的一种可行且安全的替代方法，其侵入性血管造影显示无阻塞性CAD的发生率显著降低。
In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFRCT) is unknown. At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing (n = 287) or CTA/FFRCT (n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFRCT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFRCT arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53–69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFRCT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFRCT) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFRCT arms. Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD.