PDF(Pubmed)
Abstract：
UNASSIGNED: Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings.
UNASSIGNED: The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who underwent FFR measurement on at least one vessel. In accordance with the decision-making workflow and treatment, the vessels were classified in three subgroups: (i) angio-revascularized, (ii) FFR-revascularized, (iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis was carried out at vessel- and patient-level.
UNASSIGNED: 1305 patients with 2422 diseased vessels fulfilled the criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95% CI: 0.4%-1.4%) and 3.3% (95% CI: 2.5%-4.3%) of cases, respectively. In FFR-deferred vessels, the overall incidence rate of TVF was 0.024 (95% CI: 0.019-0.031) lesion/year. After a median follow-up of 3.6 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. Compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95% CI: 0.024-0.034 vs. 0.049, 95% CI: 0.040-0.061 respectively, p = 0.0001). The result was consistent after correction for confounding factors and across subgroups of clinical interest. The patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups.
UNASSIGNED: In a large prospective observational study, an FFR-based strategy for the deferral of coronary lesions is a reliable and safe tool, associated with good outcomes.
UNASSIGNED: NCT03079739.
UNASSIGNED: The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who underwent FFR measurement on at least one vessel. In accordance with the decision-making workflow and treatment, the vessels were classified in three subgroups: (i) angio-revascularized, (ii) FFR-revascularized, (iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis was carried out at vessel- and patient-level.
UNASSIGNED: 1305 patients with 2422 diseased vessels fulfilled the criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95% CI: 0.4%-1.4%) and 3.3% (95% CI: 2.5%-4.3%) of cases, respectively. In FFR-deferred vessels, the overall incidence rate of TVF was 0.024 (95% CI: 0.019-0.031) lesion/year. After a median follow-up of 3.6 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. Compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95% CI: 0.024-0.034 vs. 0.049, 95% CI: 0.040-0.061 respectively, p = 0.0001). The result was consistent after correction for confounding factors and across subgroups of clinical interest. The patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups.
UNASSIGNED: In a large prospective observational study, an FFR-based strategy for the deferral of coronary lesions is a reliable and safe tool, associated with good outcomes.
UNASSIGNED: NCT03079739.
摘要：
■最近，关于血流储备分数(FFR)的疗效和有效性的问题在各种临床环境中都出现了.
■FFR指导的冠状动脉病变血运重建策略（HALE-BOPP）研究的临床结果是研究者发起的，多中心,国际前瞻性研究纳入对至少一条血管进行FFR测量的患者。按照决策工作流程和处理,血管分为三个亚组：（i）血管再血管化，(ii)FFR血运重建，(iii)FFR-递延。主要终点是目标血管衰竭的发生(TVF，心脏死亡,靶血管心肌梗死和缺血驱动的靶血管血运重建)。在血管和患者水平进行分析。
■1305名患有2422条病变血管的患者符合本分析的标准。电线相关的陷阱和一过性腺苷相关的副作用发生在0.8％（95％CI：0.4％-1.4％）和3.3％（95％CI：2.5％-4.3％）的病例中，分别。在FFR延迟的船只中，TVF的总发生率为0.024(95%CI:0.019-0.031)病变/年.经过3.6年的中位随访，TVF的发生率为6%，7%和11.7%的FFR递延，FFR血管重建和血管血管重建血管，分别。与血管重建血管相比，FFR引导的血管（FFR血运重建和FFR延迟血管）显示TVF病变/年发生率较低（0.029，95％CI：0.024-0.034vs.0.049，95%CI：分别为0.040-0.061，p=0.0001)。校正混杂因素和临床感兴趣的亚组后，结果是一致的。患者水平分析证实，在FFR阴性患者中，TVF的发生率较低。FFR阳性亚组。
■在一项大型前瞻性观察研究中，基于FFR的冠状动脉病变延迟治疗策略是一种可靠且安全的工具,与良好的结果相关。
■NCT03079739。
■FFR指导的冠状动脉病变血运重建策略（HALE-BOPP）研究的临床结果是研究者发起的，多中心,国际前瞻性研究纳入对至少一条血管进行FFR测量的患者。按照决策工作流程和处理,血管分为三个亚组：（i）血管再血管化，(ii)FFR血运重建，(iii)FFR-递延。主要终点是目标血管衰竭的发生(TVF，心脏死亡,靶血管心肌梗死和缺血驱动的靶血管血运重建)。在血管和患者水平进行分析。
■1305名患有2422条病变血管的患者符合本分析的标准。电线相关的陷阱和一过性腺苷相关的副作用发生在0.8％（95％CI：0.4％-1.4％）和3.3％（95％CI：2.5％-4.3％）的病例中，分别。在FFR延迟的船只中，TVF的总发生率为0.024(95%CI:0.019-0.031)病变/年.经过3.6年的中位随访，TVF的发生率为6%，7%和11.7%的FFR递延，FFR血管重建和血管血管重建血管，分别。与血管重建血管相比，FFR引导的血管（FFR血运重建和FFR延迟血管）显示TVF病变/年发生率较低（0.029，95％CI：0.024-0.034vs.0.049，95%CI：分别为0.040-0.061，p=0.0001)。校正混杂因素和临床感兴趣的亚组后，结果是一致的。患者水平分析证实，在FFR阴性患者中，TVF的发生率较低。FFR阳性亚组。
■在一项大型前瞻性观察研究中，基于FFR的冠状动脉病变延迟治疗策略是一种可靠且安全的工具,与良好的结果相关。
■NCT03079739。
