{Reference Type}: Journal Article
{Title}: Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study.
{Author}: Tebaldi M;Gallo F;Scoccia A;Durante A;Tedeschi D;Verdoliva S;Cortese B;Bilotta F;Watkins S;Ielasi A;Valentini G;Pavasini R;Serenelli M;D'Aniello E;Arena M;Pompei G;Scala A;Scollo E;Gibiino F;Caglioni S;Mele D;Marrone A;Biscaglia S;Barbato E;Campo G;
{Journal}: Rev Cardiovasc Med
{Volume}: 24
{Issue}: 2
{Year}: 2023 Feb
{Factor}: 4.43
{DOI}: 10.31083/j.rcm2402062
{Abstract}: <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.