Long-term Outcome of Deferred Lesion Based on FFR (HALE-BOPP)

The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation

Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices. The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Diagnostic test: fractional flow reserve

Detailed Description

Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices.

The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

All centers capable of performing FFR were invited to participate and there were no predefined exclusion criteria, other than the patient's unwillingness to provide written informed consent.

The decision to perform FFR was left to the operator in each case. The study primary purpose was to evaluate, in the routine daily practice, the long-term clinical outcome of coronary lesions where the treatment was deferred based on FFR result.

An independent corelab will review all angiograms to perform quantitative coronary analysis, calculation of syntax score, residual syntax score, functional syntax score and, in ACS patients, discrimination between culprit and non culprit lesions An indipendent committee will assess and adjudicate all adverse events.

• Study Type: Observational
• Enrollment (Actual): 1305

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Istituto Clinico Sant'Anna
  • Como, Italy
    • Ospedale Valduce
  • Milano, Italy
    • Clinica Sant'Ambrogio
  • Milano, Italy
    • Istituto Auxologico Italiano
  • Sassari, Italy
    • AOU di Sassari
  • Avellino
    • Mercogliano, Avellino, Italy
      • Clinica Montevergine SPA
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital of Ferrara
  • L'Aquila
    • Avezzano, L'Aquila, Italy
      • Ospedale San Filippo e Nicola
  • Milano
    • Paderno Dugnano, Milano, Italy
      • Clinica San Carlo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.

Description

Inclusion Criteria:

• written consent
• age >18 years
• FFR assessment in at least one coronary lesion

Exclusion Criteria:

• life expectancy <1 year because of known noncardiovascular comorbidity
• unwillingness to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fractional flow reserve group; consecutive patients undergoing coronary artery angiography for established or suspected ischemic heart disease and receiving in at least one lesion FFR assessment	Diagnostic test: fractional flow reserve; assessment with FFR in at least one coronary lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target vessel failure	cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target vessel failure	cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.	3 years
target vessel failure	cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.	5 years

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 161082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No