冠状动脉病变FFR指导下的血运重建策略的临床结果：HALE-BOPP研究
Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study.
作者信息
Tebaldi Matteo, Gallo Francesco, Scoccia Alessandra, Durante Alessandro, Tedeschi Delio, Verdoliva Sebastiano, Cortese Bernardo, Bilotta Ferruccio, Watkins Stuart, Ielasi Alfonso, Valentini Giuliano, Pavasini Rita, Serenelli Matteo, D'Aniello Emanuele, Arena Marco, Pompei Graziella, Scala Antonella, Scollo Ennio, Gibiino Federico, Caglioni Serena, Mele Daniela, Marrone Andrea, Biscaglia Simone, Barbato Emanuele, Campo Gianluca
机构信息
Cardiovascular Institute, Azienda Ospedaliera Universitaria S. Anna, 44124 Ferrara, Italy.
Cardiology Department, Ospedale dell'Angelo di Mestre, 30174 Venice, Italy.
出版信息
Rev Cardiovasc Med. 2023 Feb 14;24(2):62. doi: 10.31083/j.rcm2402062. eCollection 2023 Feb.
BACKGROUND
Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings.
METHODS
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.
RESULTS
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, = 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.
CONCLUSIONS
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.
CLINICAL TRIAL REGISTRATION
NCT03079739.
背景
最近，在各种临床环境中，关于血流储备分数（FFR）的疗效和有效性出现了一些问题。
方法
冠状动脉病变FFR指导的血运重建策略的临床结果（HALE-BOPP）研究是一项由研究者发起的、多中心、国际前瞻性研究，纳入至少在一根血管上进行了FFR测量的患者。根据决策流程和治疗方法，将血管分为三个亚组：（i）血管造影引导下血运重建，（ii）FFR引导下血运重建，（iii）FFR延期处理。主要终点是靶血管失败（TVF，心源性死亡、靶血管心肌梗死和缺血驱动的靶血管血运重建）的发生情况。分析在血管水平和患者水平进行。
结果
1305例患者的2422根病变血管符合本分析标准。导丝相关陷阱和短暂腺苷相关副作用分别发生在0.8%（95%CI：0.4%-1.4%）和3.3%（95%CI：2.5%-4.3%）的病例中。在FFR延期处理的血管中，TVF的总体发生率为0.024（95%CI：0.019-0.031）病变/年。中位随访时间3.6年后，FFR延期处理、FFR引导下血运重建和血管造影引导下血运重建的血管中TVF的发生率分别为6%、7%和11.7%。与血管造影引导下血运重建的血管相比，FFR引导的血管（FFR引导下血运重建和FFR延期处理的血管）每年的TVF发生率较低（分别为0.029，95%CI：0.024-0.034与0.049，95%CI：0.040-0.061，P=0.0001）。校正混杂因素后以及在各临床相关亚组中，结果一致。患者水平分析证实，FFR阴性亚组与FFR阳性亚组相比，TVF发生率较低。
结论
在一项大型前瞻性观察研究中，基于FFR的冠状动脉病变延期处理策略是一种可靠、安全的工具，预后良好。
临床试验注册
NCT03079739。
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