Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study
Matteo Tebaldi1, Francesco Gallo2, Alessandra Scoccia1
1Cardiovascular Institute, Azienda Ospedaliera Universitaria S. Anna, 44124 Ferrara, Italy.
Insights
Fractional Flow Reserve (FFR) guidance for coronary lesions is safe and effective. FFR-guided strategies, including deferral, showed lower target vessel failure rates compared to angio-guided revascularization in a large prospective study.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Questions regarding the efficacy of Fractional Flow Reserve (FFR) have emerged in clinical practice.
- The HALE-BOPP study addresses these concerns through a prospective, international, multicenter trial.
Purpose of the Study:
- To evaluate the effectiveness and safety of an FFR-guided revascularization strategy for coronary lesions.
- To compare outcomes between angio-guided, FFR-guided revascularized, and FFR-deferred lesions.
Main Methods:
- Prospective, multicenter international study (HALE-BOPP) involving 1305 patients with 2422 treated vessels.
- Vessels categorized into angio-revascularized, FFR-revascularized, or FFR-deferred subgroups.
- Primary endpoint: Target Vessel Failure (TVF), including cardiac death, MI, and revascularization, analyzed at vessel and patient levels.
Main Results:
- Low rates of procedural complications (0.8% wire-related, 3.3% adenosine-related).
- FFR-deferred vessels showed a TVF incidence rate of 0.024 lesion/year.
- FFR-guided vessels (revascularized and deferred) demonstrated significantly lower TVF rates (0.029 lesion/year) compared to angio-revascularized vessels (0.049 lesion/year) over 3.6 years median follow-up.
Conclusions:
- An FFR-based strategy for deferring coronary lesions is reliable and safe.
- FFR guidance is associated with favorable clinical outcomes, reducing target vessel failure.
- The study supports the use of FFR in guiding revascularization decisions.
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.
More Related Videos
06:32Evaluation of Coronary Flow Reserve After Myocardial Ischemia Reperfusion in Rats
Published on: June 28, 2019
13:48Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultrasound
Published on: April 21, 2023
