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:10.31083/j.rcm2402062

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

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

Authors

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 Barbato^{12

13}, Gianluca Campo¹

Affiliations

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.

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.

Associated data

ClinicalTrials.gov/NCT03079739

Grants and funding

This study was partially supported by a research grant from Boston Scientific, (Natick, MA, USA), which had no role in the collection, analysis, and interpretation of data, writing of the report and the decision to submit the paper for publication.