Department of Radiology and Imaging Sciences Emory University Atlanta GA.
Department of Biostatistics Brown University School of Public Health Providence RI.
J Am Heart Assoc. 2020 Dec 15;9(24):e017993. doi: 10.1161/JAHA.120.017993. Epub 2020 Dec 5.
Background The RESCUE (Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Noninvasive Examinations) trial was a randomized, controlled, multicenter, comparative efficacy outcomes trial designed to assess whether initial testing with coronary computed tomographic angiography (CCTA) is noninferior to single photon emission computed tomography (SPECT) myocardial perfusion imaging in directing patients with stable angina to optimal medical therapy alone or optimal medical therapy with revascularization. Methods and Results The end point was first major adverse cardiovascular event (MACE) (cardiac death or myocardial infarction), or revascularization. Noninferiority margin for CCTA was set a priori as a hazard ratio (HR) of 1.3 (95% CI=0, 1.605). One thousand fifty participants from 44 sites were randomized to CCTA (n=518) or SPECT (n=532). Mean follow-up time was 16.2 (SD 7.9) months. There were no cardiac-related deaths. In patients with a negative CCTA there was 1 acute myocardial infarction; in patients with a negative SPECT examination there were 2 acute myocardial infarctions; and for positive CCTA and SPECT, 1 acute myocardial infarction each. Participants in the CCTA arm had a similar rate of MACE or revascularization compared with those in the SPECT myocardial perfusion imaging arm, (HR, 1.03; 95% CI=0.61-1.75) (=0.19). CCTA segment involvement by a stenosis of ≥50% diameter was a better predictor of MACE and revascularization at 1 year (=0.02) than the percent reversible defect size by SPECT myocardial perfusion imaging. Four (1.2%) patients with negative CCTA compared with 14 (3.2%) with negative SPECT had MACE or revascularization (=0.03). Conclusions There was no difference in outcomes of patients who had stable angina and who underwent CCTA in comparison to SPECT as the first imaging test directing them to optimal medical therapy alone or with revascularization. CCTA was a better predictor of MACE and revascularization. Registration Information URL: https://www.clinicaltrials.gov/. Identifier: NCT01262625.
RESCUE（比较稳定型心绞痛患者利用无创检查的随机评估）试验是一项随机、对照、多中心、比较疗效结局的临床试验，旨在评估在指导稳定型心绞痛患者接受单纯最佳药物治疗或最佳药物治疗联合血运重建时，初始使用冠状动脉计算机断层扫描血管造影（CCTA）是否不劣于单光子发射计算机断层扫描（SPECT）心肌灌注成像。
终点为首次主要不良心血管事件（MACE）（心脏死亡或心肌梗死）或血运重建。CCTA 的非劣效性边界预先设定为危险比（HR）为 1.3（95%CI=0，1.605）。44 个地点的 1050 名参与者被随机分配至 CCTA（n=518）或 SPECT（n=532）组。平均随访时间为 16.2（SD 7.9）个月。无心脏相关死亡。在 CCTA 阴性的患者中有 1 例急性心肌梗死；在 SPECT 检查阴性的患者中有 2 例急性心肌梗死；而在 CCTA 和 SPECT 阳性的患者中，各有 1 例急性心肌梗死。CCTA 组的 MACE 或血运重建率与 SPECT 心肌灌注成像组相似，（HR，1.03；95%CI=0.61-1.75）（=0.19）。CCTA 节段狭窄≥50%的狭窄程度比 SPECT 心肌灌注成像的可逆转缺陷百分比更能预测 1 年时的 MACE 和血运重建（=0.02）。与 SPECT 阴性的患者相比，有 4 例（1.2%）CCTA 阴性的患者和 14 例（3.2%）SPECT 阴性的患者发生了 MACE 或血运重建（=0.03）。
在指导稳定型心绞痛患者接受单纯最佳药物治疗或最佳药物治疗联合血运重建时，与 SPECT 相比，接受 CCTA 的患者的结局没有差异。CCTA 是 MACE 和血运重建的更好预测指标。
