%0 Journal Article
%T Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study.
%A Tebaldi M
%A Gallo F
%A Scoccia A
%A Durante A
%A Tedeschi D
%A Verdoliva S
%A Cortese B
%A Bilotta F
%A Watkins S
%A Ielasi A
%A Valentini G
%A Pavasini R
%A Serenelli M
%A D'Aniello E
%A Arena M
%A Pompei G
%A Scala A
%A Scollo E
%A Gibiino F
%A Caglioni S
%A Mele D
%A Marrone A
%A Biscaglia S
%A Barbato E
%A Campo G
%J Rev Cardiovasc Med
%V 24
%N 2
%D 2023 Feb
%M 39077421
%F 4.43
%R 10.31083/j.rcm2402062
%X <B>UNASSIGNED: </B>Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>NCT03079739.