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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Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study
Matteo Tebaldi1,*, Francesco Gallo2, Alessandra Scoccia1, Alessandro Durante3, Delio Tedeschi4, Sebastiano Verdoliva5, Bernardo Cortese6, Ferruccio Bilotta7, Stuart Watkins8, Alfonso Ielasi9, Giuliano Valentini10, Rita Pavasini1, Matteo Serenelli1, Emanuele D’Aniello1, Marco Arena11, Graziella Pompei1, Antonella Scala1, Ennio Scollo1, Federico Gibiino1, Serena Caglioni1, Daniela Mele1, Andrea Marrone1, Simone Biscaglia1, Emanuele Barbato12,13, Gianluca Campo1
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1
Cardiovascular Institute, Azienda Ospedaliera Universitaria S. Anna, 44124 Ferrara, Italy
2
Cardiology Department, Ospedale dell’Angelo di Mestre, 30174 Venice, Italy
3
Cardiology Department, Policlinico San Marco, 24040 Zingonia (BG), Italy
4
Cardiology Department, Istituto Clinico S. Anna, 25127 Brescia (BS), Italy
5
Cardiology Department, Clinica Montervergine, 83013 Mercogliano (AV), Italy
6
Cardiology Department, Clinica San Carlo, 20037 Paderno Dugnano (MI), Italy
7
Cardiology Department, Ospedale Civile SS Annunziata, 07100 Sassari (SS), Italy
8
Department of Interventional Cardiology, West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, G81 4DY Glasgow, UK
9
Cardiology Department, Istituto Clinico Sant’Ambrogio, 20149 Milano (MI), Italy
10
Cardiology Department, Ospedale San Filippo e Nicola, 67051 Avezzano (AQ), Italy
11
Cardiology Department, Ospedale S. Andrea, 19121 La Spezia, Italy
12
Cardiovascular Center Aalst, OLV Clinic, 9300 Aalst, Belgium
13
Department of Advanced Biomedical Sciences, University Federico II, 80138 Naples, Italy
*Correspondence: tblmtt@unife.it (Matteo Tebaldi)
Rev. Cardiovasc. Med. 2023, 24(2), 62;
https://doi.org/10.31083/j.rcm2402062
Submitted: 7 September 2022 | Revised: 5 December 2022 | Accepted: 6 December 2022 | Published: 14 February 2023
(This article belongs to the Special Issue Myocardial infarction: unsolved issues and future options)
Copyright: © 2023 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.
Abstract
Keywords
fractional flow reserve
target vessel failure
FFR-based deferral
coronary revascularization
Funding
Boston Scientific
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