FFR 对医疗实践和临床结果的 1 年影响：ADVANCE 注册研究。
1-Year Impact on Medical Practice and Clinical Outcomes of FFR: The ADVANCE Registry.
机构信息
Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
出版信息
JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):97-105. doi: 10.1016/j.jcmg.2019.03.003. Epub 2019 Mar 17.
OBJECTIVES
The 1-year data from the international ADVANCE (Assessing Diagnostic Value of Non-invasive FFR in Coronary Care) Registry of patients undergoing coronary computed tomography angiography (CTA) was used to evaluate the relationship of fractional flow reserve derived from coronary CTA (FFR) with downstream care and clinical outcomes.
BACKGROUND
Guidelines for management of chest pain using noninvasive imaging pathways are based on short- to intermediate-term outcomes.
METHODS
Patients (N = 5,083) evaluated for clinically suspected coronary artery disease and in whom atherosclerosis was identified by coronary CTA were prospectively enrolled at 38 international sites from July 15, 2015, to October 20, 2017. Demographics, symptom status, coronary CTA and FFR findings and resultant site-based treatment plans, and clinical outcomes through 1 year were recorded and adjudicated by a blinded core laboratory. Major adverse cardiac events (MACE), death, myocardial infarction (MI), and acute coronary syndrome leading to urgent revascularization were captured.
RESULTS
At 1 year, 449 patients did not have follow-up data. Revascularization occurred in 1,208 (38.40%) patients with an FFR ≤0.80 and in 89 (5.60%) with an FFR >0.80 (relative risk [RR]: 6.87; 95% confidence interval [CI]: 5.59 to 8.45; p < 0.001). MACE occurred in 55 patients, 43 events occurred in patients with an FFR ≤0.80 and 12 occurred in those with an FFR >0.80 (RR: 1.81; 95% CI: 0.96 to 3.43; p = 0.06). Time to first event (all-cause death or MI) occurred in 38 (1.20%) patients with an FFR ≤0.80 compared with 10 (0.60%) patients with an FFR >0.80 (RR: 1.92; 95% CI: 0.96 to 3.85; p = 0.06). Time to first event (cardiovascular death or MI) occurred cardiovascular death or MI occurred more in patients with an FFR ≤0.80 compared with patients with an FFR >0.80 (25 [0.80%] vs. 3 [0.20%]; RR: 4.22; 95% CI: 1.28 to 13.95; p = 0.01).
CONCLUSIONS
The 1-year outcomes from the ADVANCE FFR Registry show low rates of events in all patients, with less revascularization and a trend toward lower MACE and significantly lower cardiovascular death or MI in patients with a negative FFR compared with patients with abnormal FFR values. (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Wave [ADVANCE]; NCT02499679).
目的
利用 ADVANCE（评估冠状动脉护理中无创 FFR 的诊断价值）国际注册研究的 1 年数据，评估通过冠状动脉 CT 血管造影（CTA）获得的血流储备分数（FFR）与下游治疗和临床结局的关系。
背景
使用非侵入性影像学途径管理胸痛的指南基于短期至中期结果。
方法
2015 年 7 月 15 日至 2017 年 10 月 20 日，在 38 个国际中心前瞻性招募了因疑似冠心病而接受评估且 CTA 显示存在动脉粥样硬化的患者。记录患者的人口统计学、症状状态、CTA 和 FFR 结果以及由此产生的基于地点的治疗计划，以及通过 1 年的临床结局，并由盲法核心实验室进行裁决。主要不良心脏事件（MACE）、死亡、心肌梗死（MI）和导致紧急血运重建的急性冠状动脉综合征被捕获。
结果
1 年后，449 名患者没有随访数据。在 FFR ≤0.80 的 1208 名患者（38.40%）和 FFR >0.80 的 89 名患者（5.60%）中发生了血运重建（相对风险 [RR]：6.87；95%置信区间 [CI]：5.59 至 8.45；p < 0.001）。55 名患者发生了 MACE，在 FFR ≤0.80 的患者中有 43 例事件发生，而在 FFR >0.80 的患者中有 12 例事件发生（RR：1.81；95%CI：0.96 至 3.43；p = 0.06）。在 FFR ≤0.80 的 38 名患者中（1.20%）发生了首次事件（全因死亡或 MI），而在 FFR >0.80 的 10 名患者中（0.60%）发生了首次事件（RR：1.92；95%CI：0.96 至 3.85；p = 0.06）。在 FFR ≤0.80 的患者中（0.80%）首次发生心血管死亡或 MI 的患者比例高于 FFR >0.80 的患者（25 [0.80%] vs. 3 [0.20%]；RR：4.22；95%CI：1.28 至 13.95；p = 0.01）。
结论
ADVANCE FFR 注册研究的 1 年结果显示，所有患者的事件发生率均较低，FFR 阴性患者的血运重建较少，且 MACE 和明显较低的心血管死亡或 MI 发生率呈下降趋势与 FFR 值异常的患者相比。（评估冠状动脉 Wave 无创 FFRCT 的诊断价值 [ADVANCE]；NCT02499679）。
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