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症状性 CAD 患者药物负荷 SPECT 和 PET MPI 临床疗效的随机比较。

Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients.

机构信息

Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.

Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.

出版信息

JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.

Abstract

OBJECTIVES

This study compared the clinical effectiveness of pharmacologic stress myocardial perfusion imaging (MPI) plus positron emission tomography (PET) with single-photon emission computed tomography (SPECT) in patients with known coronary artery disease (CAD) presenting with symptoms suggestive of ischemia.

BACKGROUND

Although PET MPI has been shown to have higher diagnostic accuracy in detecting hemodynamically significant CAD than SPECT MPI, whether this impacts downstream management has not been formally evaluated in randomized trials.

METHODS

This study consisted of a single-center trial in which patients with known CAD and suspected ischemia were randomized to undergo PET or attenuation-corrected SPECT MPI between June 2009 and September 2013. Post-test management was at the discretion of the referring physician, and patients were followed for 12 months. The primary endpoint was diagnostic failure, defined as unnecessary angiography (absence of ≥50% stenosis in ≥1 vessel) or additional noninvasive testing within 60 days of the MPI. Secondary endpoints were post-test escalation of antianginal therapy, referral for angiography, coronary revascularization, and health status at 3, 6, and 12 months.

RESULTS

A total of 322 patients with an evaluable MPI were randomized (n = 161 in each group). At baseline, 88.8% of patients were receiving aspirin therapy, 76.7% were taking beta-blockers, and 77.3% were taking statin therapy. Diagnostic failure within 60 days occurred in only 7 patients (2.2%) (3 [1.9%] in the PET group and 4 [2.5%] in the SPECT group; p = 0.70). There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however, when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).

CONCLUSIONS

In this contemporary cohort of symptomatic CAD patients who were optimally medically managed, there were no discernible differences in rates of diagnostic failure at 60 days, subsequent coronary angiography, revascularization, or patient health status at 1 year between patients evaluated by pharmacologic PET compared with those evaluated by SPECT MPI. Downstream invasive testing rates with PET MPI were more consistent with high-risk features than those with SPECT MPI. (Effectiveness Study of Single Photon Emission Computed Tomography [SPECT] Versus Positron Emission Tomography [PET] Myocardial Perfusion Imaging; NCT00976053).

摘要

目的

本研究比较了在有症状的疑似缺血的已知冠心病患者中,药物负荷心肌灌注成像(MPI)加正电子发射断层扫描(PET)与单光子发射计算机断层扫描(SPECT)的临床疗效。

背景

尽管 PET MPI 在检测有血流动力学意义的 CAD 方面比 SPECT MPI 具有更高的诊断准确性,但这种影响是否会在随机试验中正式评估尚未进行。

方法

本研究为单中心试验,2009 年 6 月至 2013 年 9 月间,将有已知 CAD 和疑似缺血的患者随机分为接受 PET 或衰减校正 SPECT MPI。检测后管理由转诊医生决定,患者随访 12 个月。主要终点为诊断失败,定义为 60 天内无需行血管造影(≥1 支血管狭窄≥50%)或进行额外的无创检查。次要终点为检测后抗心绞痛治疗升级、行血管造影、冠状动脉血运重建以及 3、6 和 12 个月时的健康状况。

结果

共有 322 例可评估 MPI 的患者被随机分配(每组 n = 161)。基线时,88.8%的患者正在服用阿司匹林,76.7%的患者服用β受体阻滞剂,77.3%的患者服用他汀类药物。在 60 天内仅发生 7 例(2.2%)诊断失败(PET 组 3 例[1.9%],SPECT 组 4 例[2.5%];p = 0.70)。在随后的冠状动脉造影、血运重建或 3、6 和 12 个月的随访时,两组间的健康状况均无显著差异(所有 p 值均≥0.20);然而,在对 MPI 结果进行事后分析的分层后,在 PET 检测中高危 MPI 的患者在随访中进行血管造影和血运重建的比例较高,而进行低危 PET 研究的患者在这两项检查中都比 SPECT 进行得少(随机方式与高危 MPI 之间的交互作用:12 个月时的导管检查 [p = 0.001]和 12 个月时的血运重建 [p = 0.09])。

结论

在当前接受最佳药物治疗的有症状 CAD 患者中,与 SPECT MPI 相比,接受药物负荷 PET 评估的患者在 60 天内的诊断失败率、随后的冠状动脉造影、血运重建或 1 年内的患者健康状况没有明显差异。使用 PET MPI 的有创性检查率与高危特征更一致。(单光子发射计算机断层扫描 [SPECT]与正电子发射断层扫描 [PET]心肌灌注成像的有效性研究;NCT00976053)。

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