Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study

Abstract

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) angiorevascularized, (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%

Study design and rationale of the angio-based final functional effect of PCI (AFFE PCI) study: a prospective multi-center study of post-PCI vFFR impact on clinical outcomes and residual angina

“…On top of the diagnostic role in evaluation of hemodynamical significance of stenosis, pre-procedural and final PCI effect physiological assessment may become a useful factor in the evaluation of PCI results and future risk stratification, especially with the use of the non-invasive angiography-derived FFR methods [ 27 – 29 ]. This is a rapidly evolving field, offering faster, precise, and easier-to-use software that have recently been validated against invasive indices [ 3 , 11 ]. Consequently, these modalities, including vFFR may be a crucial adjunct to intravascular imaging in the PCI guidance and evaluation of the risk of future complications in the initially treated coronary artery.…”

“…The primary invasive modality for diagnosing coronary artery disease (CAD) is coronary angiography (CAG) [ 1 ], nevertheless, CAG is limited by its inability of direct evaluation of stenosis hemodynamic relevance [ 2 ]. Among the methods developed to improve the diagnostics and management of CAD there are fractional flow reserve (FFR) and non-hyperemic pressure indices (NHPRs), which at present constitute a gold standard for lesion significance assessment and revascularization guidance [ 3 ]. FFR is an invasive modality employing pressure wire and adenosine infusion to measure the ratio between the mean pressure distal to the stenosis (Pd) and the mean aortic pressure (Pa) during maximal hyperemia within a specific coronary artery segment.…”

Functional (Re)Development of SYNTAX Score II 2020: Predictive Performance and Risk Assessment

“…A detailed description of the Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) registry has been previously published [ 12 ]. In brief, the HALE-BOPP [ 12 ] is an investigator-initiated, multicenter, international prospective study with the aim to compare, at vessel-level and patient-level, the long-term outcome of FFR-based deferral vs. FFR-guided and angio-guided revascularization. The study consecutively enrolled 1305 patients who underwent FFR measurement on at least one vessel with COMET ® wire (Boston Scientific, St. Paul, MN, USA).…”

“…The vessels showing a coronary lesion with DS ≥ 90% or being the culprit lesion of an acute event must be directly treated with revascularization. The remaining coronary lesions should undergo FFR measurement to guide revascularization [ 12 ]. Operators proceeded with angio-guided revascularization in 760 vessels.…”

“…The consequent risk is to overestimate the anatomic burden of disease by including vessels with negative physiology whose treatment does not provide the patient with a prognostic benefit. The aim of the present study is to test and investigate the clinical prognostic value of the newly (re)developed functional Syntax Score II 2020 score and to evaluate its ability to better address treatment by benefit prediction among patients with complex CAD enrolled in a prospective international registry of consecutive patients receiving FFR evaluation [ 12 ].…”