Reviews in Cardiovascular Medicine (Feb 2023)

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

  • Matteo Tebaldi,
  • Francesco Gallo,
  • Alessandra Scoccia,
  • Alessandro Durante,
  • Delio Tedeschi,
  • Sebastiano Verdoliva,
  • Bernardo Cortese,
  • Ferruccio Bilotta,
  • Stuart Watkins,
  • Alfonso Ielasi,
  • Giuliano Valentini,
  • Rita Pavasini,
  • Matteo Serenelli,
  • Emanuele D’Aniello,
  • Marco Arena,
  • Graziella Pompei,
  • Antonella Scala,
  • Ennio Scollo,
  • Federico Gibiino,
  • Serena Caglioni,
  • Daniela Mele,
  • Andrea Marrone,
  • Simone Biscaglia,
  • Emanuele Barbato,
  • Gianluca Campo

DOI
https://doi.org/10.31083/j.rcm2402062
Journal volume & issue
Vol. 24, no. 2
p. 62

Abstract

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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.

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