非侵入性冠脉检查可准确检测病变特异性缺血
旧金山——在美国心脏病学会(ACC)主办的经导管心血管治疗(TCT)年会上公布的一项涉及254例患者和484处病变的研究显示，与CT血管造影或侵入性冠状动脉造影的解剖评估相比，一种根据冠状动脉CT造影图像计算血流储备分数的非侵入性检查(FFRCT)在检测缺血方面具有高度准确性。
该研究在丹麦奥尔胡斯大学和3个大洲的10个中心进行，入选进行CT和侵入性冠状动脉血管造影(检查之间间隔不超过60天)的患者。主要终点是根据该新型FFRCT检查的受试者工作特征曲线下面积(AUC)评估的其在诊断缺血方面的按患者诊断性能(与冠状动脉CT造影相比)。结果显示，FFRCT的AUC为0.82，显著优于冠状动脉CT造影的0.63。与冠状动脉CT造影评估相比，FFRCT使特异性增加了近1倍。并且FFRCT正确将68%的CT血管造影假阳性病例重新归类为真阴性。
在254例患者中，FFRCT的准确性为81%，而侵入性冠状动脉造影和CT血管造影解剖评估的准确性分别为64%和53%。FFRCT的特异性为79%，而侵入性血管造影为51%，CT血管造影为34%。FFRCT的阳性预测值为65%，而侵入性血管造影为46%，CT血管造影为40%。在所有这些类别中，FFRCT的性能均显著优于CT血管造影。FFRCT按患者诊断的敏感性为86%，侵入性血管造影为91%，CT血管造影为94%。FFRCT的阴性预测值为92%，侵入性血管造影为93%，CT血管造影为92%。敏感性和阴性预测值的组间差异不显著。
484处病变的结果也表现出相似趋势。FFRCT的准确性为86%，侵入性血管造影为71%，CT血管造影为65%。三者的按血管特异性分别为86%、66%和60%，FFRCT的阳性预测值为61%，侵入性血管造影为40%，CT血管造影为33%。敏感性(分别为84%、84%和83%)和阴性预测值(95%、94%和92%)无显著丢失。主要研究者Bjarne
L.
N?rgaard医生表示，FFRCT和FFR侵入性评估的准确性优于其他检查，包括负荷回声、冠状动脉CT血管造影(cCTA)、使用腔内衰减梯度的cCTA、单光子发射CT和血管内超声。
评论专家指出，这种检查将被整合入临床实践中。尚需进形成本分析。预计未来2~3年，缺血的非侵入性评估将取得显著进展。该研究由FFRCT检查的经销商HeartFlow资助。N?rgaard医生声明无其他经济利益冲突。评论专家声明与多家药企存在利益关系，但与HeartFlow无利益关系。
By: SHERRY BOSCHERT, Cardiology News Digital Network
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve
from coronary CT angiography images was highly accurate in detecting
ischemia, compared with anatomic interpretation from CT angiography or
invasive coronary angiography, in a study of 254 patients and 484
vessels.
The primary endpoint was per-patient diagnostic performance as assessed
by the area under the receiver operating characteristic curve (AUC) of
the test, compared with coronary CT angiography, for the diagnosis of
ischemia. The AUC for the new test was 0.82, significantly better than
0.63 for coronary CT angiography, Dr. Bjarne L. N?rgaard reported at the
Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to
compute fractional flow reserve from coronary CT angiography images
(FFRCT), compared with coronary CT angiography assessment. FFRCT
correctly reclassified 68% of false positives from CT angiography to
true negatives, said Dr. N?rgaard of Aarhus (Denmark) University.
Invasive assessment of FFR is considered the gold standard for diagnosis
of lesion-specific functional ischemic disease, but it carries more
risk than a noninvasive test. Coronary CT angiography detects anatomic
stenosis but is not good at determining the physiologic significance of
lesions, he said.
The FFRCT technology builds a quantitative model using data from
conventional coronary CT images, and develops a physiological model
using left ventricular and coronary anatomy and established
form-function principles, Dr. N?rgaard said. A fluid model calculates
flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for
anatomic assessment using invasive coronary angiography and 53% with CT
angiography. The specificity was 79% with FFRCT, 51% with invasive
angiography, and 34% with CT angiography. Positive predictive values
were 65% with FFRCT, 46% with invasive angiography, and 40% with CT
angiography. In each of these categories, FFRCT performed significantly
better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with
invasive angiography, and 94% with CT angiography. The negative
predictive values were 92% with FFRCT, 93% with invasive angiography,
and 92% with CT angiography. Differences between groups were not
significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study.
FFRCT had an accuracy of 86%, compared with 71% for invasive angiography
and 65% for CT angiography. The per-vessel specificities were 86%, 66%,
and 60%, respectively, and the positive predictive value was 61% with
FFRCT, 40% with invasive angiography, and 33% with CT angiography.
Again, there was no significant loss in sensitivity (84%, 84%, and 83%,
respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably
with the accuracy of other tests, Dr. N?rgaard said, including stress
echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation
gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who
underwent CT and invasive coronary angiography with no more than 60 days
between tests.
"I think this will be incorporated into practice," Dr. James B.
Hermiller Jr. commented in a panel discussion of the study during a
press briefing. A cost **ysis is needed, added Dr. Hermiller of St.
Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of H?pital du Sacré-Coeur de Montréal, called the
trial "a brilliant study" and "a breath of fresh air" in the area of
noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This
is a really important trial." He predicted that over the next 2-3 years,
great strides will be made in noninvasive assessments of ischemia.
"Stay tuned. A number of other methods for evaluating FFR" are being
studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. N?rgaard
reported having no other financial disclosures. Dr. Hermiller, Dr.
Généreux, and Dr. Gersh reported financial associations with multiple
companies, but not with HeartFlow.
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