Douglas Pamela S, Pontone Gianluca, Hlatky Mark A, Patel Manesh R, Norgaard Bjarne L, Byrne Robert A, Curzen Nick, Purcell Ian, Gutberlet Matthias, Rioufol Gilles, Hink Ulrich, Schuchlenz Herwig Walter, Feuchtner Gudrun, Gilard Martine, Andreini Daniele, Jensen Jesper M, Hadamitzky Martin, Chiswell Karen, Cyr Derek, Wilk Alan, Wang Furong, Rogers Campbell, De Bruyne Bernard
Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA
Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
Eur Heart J. 2015 Dec 14;36(47):3359-67. doi: 10.1093/eurheartj/ehv444. Epub 2015 Sep 1.
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/FFR(CT) (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 (FFR(CT)-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR(CT) 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/FFR(CT) results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR(CT)) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR(CT) 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.
在疑似冠心病（CAD）的有症状患者中，与功能测试相比，计算机断层血管造影（CTA）可改善侵入性冠状动脉造影（ICA）的患者选择。通过CTA测量血流储备分数（FFRCT）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/FFR（CT）（n = 297）。检查结果解读和治疗决策由临床护理团队做出。主要终点是计划进行ICA的患者中，在90天内ICA检查未发现明显阻塞性CAD（核心实验室定量分析无狭窄≥50%或侵入性FFR < 0.80）的患者百分比。包括死亡、心肌梗死和非计划血管重建在内的次要终点由独立且盲法判定。受试者平均年龄61±11岁，40%为女性，阻塞性CAD的平均检查前概率为49±17%。在计划进行ICA的患者中（FFR（CT）引导组 = 193；常规护理组 = 187），CTA/FFR（CT）组24例（12%）在ICA检查中未发现阻塞性CAD，常规护理组137例（73%）（风险差异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）。在收到CTA/FFR（CT）结果后，61%的患者取消了侵入性冠状动脉造影。在计划进行非侵入性检查的患者中，ICA检查未发现阻塞性CAD的比例分别为13%（CTA/FFR（CT））和6%（常规护理；P = 0.95）。常规护理组和CTA/FFR（CT）组90天内的临床事件发生率较低。
CTA测量血流储备分数是ICA一种可行且安全的替代方法，与侵入性血管造影显示无阻塞性CAD的比例显著降低相关。
Zotero 插件