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. 2023 Feb 14;24(2):62.
doi: 10.31083/j.rcm2402062. eCollection 2023 Feb.

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

Matteo Tebaldi  1 , Francesco Gallo  2 , Alessandra Scoccia  1 , Alessandro Durante  3 , Delio Tedeschi  4 , Sebastiano Verdoliva  5 , Bernardo Cortese  6 , Ferruccio Bilotta  7 , Stuart Watkins  8 , Alfonso Ielasi  9 , Giuliano Valentini  10 , Rita Pavasini  1 , Matteo Serenelli  1 , Emanuele D'Aniello  1 , Marco Arena  11 , Graziella Pompei  1 , Antonella Scala  1 , Ennio Scollo  1 , Federico Gibiino  1 , Serena Caglioni  1 , Daniela Mele  1 , Andrea Marrone  1 , Simone Biscaglia  1 , Emanuele Barbato  12   13 , Gianluca Campo  1
Affiliations

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

Matteo Tebaldi et al. Rev Cardiovasc Med. .

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) 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, 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.

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.

Keywords: FFR-based deferral; coronary revascularization; fractional flow reserve; target vessel failure.

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Conflict of interest statement

SW received speaker fees from Boston Scientific. GC received research grant from Boston Scientific, SMT, Abbott Vascular, Astrazeneca. MT received research grant from GADA, Abbott Vascular. SB received research grant from SMT, Siemens Healthcare, GE Healthcare. Bernardo Cortese and Gianluca Campo are serving as Guest editors of this journal. We declare that Bernardo Cortese and Gianluca Campo had no involvement in the peer review of this article and have no access to information regarding its peer review. Full responsibility for the editorial process for this article was delegated to Jerome L. Fleg. All other authors have nothing to disclose.

Figures

Fig. 1.
Fig. 1.
Study flow-chart. FFR, fractional flow reserve; CABG, coronary artery graft bypass; CTO, chronic total occlusion; TVR, target vessel revascularization.
Fig. 2.
Fig. 2.
Subgroup analysis in the comparison of FFR-deferral vs. revascularization. HR, hazard risk; CKD, chronic kidney disease; CCS, chronic coronary syndrome; ACS, acute coronary syndrome; LVEF, left ventricular ejection fraction; LM, left main; LAD, left anterior descending artery; RCA, right coronary artery; LCx, left circumflex artery; FFR, fractional flow reserve.
Fig. 3.
Fig. 3.
Cumulative survival free from target vessel failure in FFR-guided vessels vs. Angio-guided vessels. FFR, fractional flow reserve; HR, hazard risk.
Fig. 4.
Fig. 4.
Central Illustration.
See this image and copyright information in PMC

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