冠状动脉有创功能学检查研究进展

doi:10.3969/j.issn.1674-8115.2022.06.017

摘要/Abstract

摘要：

血流储备分数（fractional flow reverse， FFR）作为一项有创功能学检查技术，其诊断效能已被大量研究证实。由于其优于传统的单纯选择性冠状动脉造影（coronary artery angiography，CAG），现已成为诊断冠状动脉病变严重程度的“金标准”。然而，FFR由于需要使用血管扩张药物进行血管预处理，且加之冠状动脉压力导丝的通过性能不佳、检查操作时间长等因素，FFR的临床应用受到限制，无法广泛使用。因此，瞬时无波比（instantaneous wave-free ratio，iFR）及定量血流分数（quantitative flow ratio，QFR）等FFR的衍生指标应运而生。已有研究证实，这些指标与FFR具有良好的一致性。此外，这些衍生指标在测量中简化了操作流程，避免了血管扩张药物的使用，同时可以取得与FFR接近的功能学数据，给术者提供了可靠的支持，并减少了患者的不良反应，有望成为FFR的替代检查在临床中广泛应用。近年来，多项重要研究的发表为冠状动脉功能学检查提供了新的循证证据支持，研究内容涵盖检查方法学的更新、诊断效能的对比、检查范围的扩展、长期随访数据的公布等多个方面。该文对近年FFR、iFR、QFR的相关研究进行综述。

关键词: 冠状动脉疾病, 冠状动脉功能学检查, 血流储备分数, 瞬时无波比, 定量血流分数

Abstract:

Fractional flow reserve (FFR) is an invasive functional examination. Its diagnostic performance has been confirmed by a large number of studies. Because of its superiority to the traditional method of pure selective coronary angiography (CAG), it has now become the “gold standard” for diagnosing the severity of coronary artery disease. However, the need to use vasodilators for vascular pretreatment, poor coronary pressure guide wire passing performance, long inspection operation time and other factors make FFR limited in clinical application and could not be widely used. Therefore, derived indicators of FFR such as instantaneous wave-free ratio (iFR) and quantitative flow ratio (QFR) have been generated. Studies have confirmed that these indicators are in good agreement with FFR. In addition, these derived indicators simplify the operation process in the measurement, avoid the use of vasodilators, and can obtain functional data close to FFR at the same time, which provide reliable support for the operator and reduce the adverse effects of patients.Therefore, they are expected to be widely used in clinical practice as an alternative to FFR. In recent years, the publication of a number of important studies has provided new evidence-based data. These studies include the update of examination methodologies, the comparison of diagnostic performance, the expansion of examination scope, and the publication of long-term follow-up data, etc. This paper reviewed the related studies in recent years.

Key words: coronary artery disease, coronary functional assessment, fractional flow reverse (FFR), instantaneous wave-free ratio (iFR), quantitative flow ratio (QFR)

中图分类号:

R541.4

蒋越, 何奔. 冠状动脉有创功能学检查研究进展[J]. 上海交通大学学报（医学版）, 2022, 42(6): 813-818.

JIANG Yue, HE Ben. Research progress of invasive functional assessment of coronary artery disease[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2022, 42(6): 813-818.

图/表 3

参考文献 37

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Study	Year	Patients	Cut-off value	Primary endpoint	Conclusion
DEFER^［5］	2001	91	<0.75	adverse cardiac events	DEFER vs PEFORM （FFR guided） P=0.21
FAME^［6］	2009	509	≤0.80	MACE	FFR vs CAG P<0.001
FAME 2^［16］	2012	447	≤0.80	MACE	FFR-guided PCI + OMT vs OMT P<0.001
FAME 3^［14］	2022	1 500	≤0.80	MACCE	FFR-guided PCI vs CABG （three-vessel CAD） P=0.35 for noninferiority
AGARWAL， et al^［17］	2016	574	≤0.86	MACE	Final FFR ≤0.86 had incremental prognostic value over clinical and angiographic variables for MACE prediction

Study	Year	Patients	Cut-off value	Primary endpoint	Conclusion
DEFER^［5］	2001	91	<0.75	adverse cardiac events	DEFER vs PEFORM （FFR guided） P=0.21
FAME^［6］	2009	509	≤0.80	MACE	FFR vs CAG P<0.001
FAME 2^［16］	2012	447	≤0.80	MACE	FFR-guided PCI + OMT vs OMT P<0.001
FAME 3^［14］	2022	1 500	≤0.80	MACCE	FFR-guided PCI vs CABG （three-vessel CAD） P=0.35 for noninferiority
AGARWAL， et al^［17］	2016	574	≤0.86	MACE	Final FFR ≤0.86 had incremental prognostic value over clinical and angiographic variables for MACE prediction

Study	Year	Patients	Design	Primary endpoint	Conclusion
RESOLVE^［19］	2012	1 768	FFR contrast	‒	iFR-FFR R²=0.66
DEFINE-FLAIR^［20］	2017	2 492	iFR-FFR	MACE	iFR-FFR P<0.001 for noninferiority
iFR-SWEDEHEART^［29］	2017	2 037	iFR-FFR	death from any cause， nonfatal MI， or unplanned revascularization	iFR-FFR P=0.007 for noninferiority
DEFINE PCI^［23］	2022	500	post-PCI	death from cardiac cause， nonfatal MI， or unplanned revascularization	68% relative reduction in clinical events at 1 yr. follow-up among patients achieving post-PCI iFR ≥ 0.95， P=0.04
EL HAJJ et al^［22］	2021	125	LM leision	‒	iFR≤0.89 was associated with IVUS-MLA <6 mm² （LM leision）

Study	Year	Patients	Design	Primary endpoint	Conclusion
RESOLVE^［19］	2012	1 768	FFR contrast	‒	iFR-FFR R²=0.66
DEFINE-FLAIR^［20］	2017	2 492	iFR-FFR	MACE	iFR-FFR P<0.001 for noninferiority
iFR-SWEDEHEART^［29］	2017	2 037	iFR-FFR	death from any cause， nonfatal MI， or unplanned revascularization	iFR-FFR P=0.007 for noninferiority
DEFINE PCI^［23］	2022	500	post-PCI	death from cardiac cause， nonfatal MI， or unplanned revascularization	68% relative reduction in clinical events at 1 yr. follow-up among patients achieving post-PCI iFR ≥ 0.95， P=0.04
EL HAJJ et al^［22］	2021	125	LM leision	‒	iFR≤0.89 was associated with IVUS-MLA <6 mm² （LM leision）

Study	Year	Patients	Design	Primary endpoint	Conclusion
FAVOR Pilot^［30］	2016	1 768	FFR contrast （core laboratories）	‒	cQFR-FFR AUC=0.92
FAVOR Ⅱ China^［31］	2017	2 492	FFR contrast （catheterization laboratory）	‒	QFR-FFR AUC=0.96
FAVOR Ⅱ Europe/Japan^［32］	2018	2 037	FFR contrast （catheterization laboratory）	‒	QFR-FFR AUC=0.92
TU et al^［35］	2021	306	FFR contrast （core laboratories）	‒	μQFR-FFR r=0.90
FAVOR Ⅲ China^［33］	2021	3 847	QFR-CAG	MACE	QFR-guided vs CAG-guided P<0.001
VAN DIEMEN et al^［34］	2020	208	FFR-QFR/SPECT/PET	‒	QFR vs SPECT/PET AUC=0.94 vs 0.63/0.82
HAWKEYE^［36］	2019	602	post-PCI	VOCE	post-PCI QFR ≤0.89 was associated with a 3-fold increase in risk for VOCE
TANG et al^［37］	2019	354	functional SYNTAX score	MACE	Q-rFSS has a better prognostic ability for the risk of MACE AUC=0.74