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Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A
Umberto Barbero1, Fabrizio D'Ascenzo1, Gianluca Campo1
1Division of Cardiology, Cardio-Thoracic Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Corso A. M. Dogliotti, 14, 10126 Torino, Italy.
Insights
Deferring revascularization guided by fractional flow reserve (FFR) is safe for most patients with anatomically significant coronary artery disease. However, patients with ostial disease and renal impairment require further risk stratification.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- Fractional flow reserve (FFR)-guided coronary intervention is recommended for intermediate stenoses.
- Concerns exist regarding FFR-guided approach in anatomically prognostic disease.
Purpose of the Study:
- To evaluate the safety and outcomes of deferring revascularization in patients with FFR-negative lesions in anatomically significant coronary sites.
- To identify predictors of major adverse cardiovascular events (MACE) in this patient cohort.
Main Methods:
- Prospective, multicenter study enrolling 292 patients with FFR-negative lesions in high-risk anatomical locations.
- Revascularization was deferred, and patients were followed for MACE (death, myocardial infarction, target lesion revascularization).
- Subgroup analyses included clinical presentation, lesion localization, and renal function.
Main Results:
- After 1-year, MACE occurred in 5% of patients, primarily driven by target lesion revascularization (2.7%).
- At a mean follow-up of 22.2 months, MACE occurred in 11.6%.
- Impaired renal function and ostial disease were identified as independent predictors of MACE and target lesion revascularization.
Conclusions:
- FFR-guided deferral of revascularization is generally safe in anatomically prognostic coronary disease.
- Further evaluation is needed for risk stratification in patients with ostial disease and renal impairment.
- The study was registered on ClinicalTrials (NCT02590926).
Background:
FFR-guided coronary intervention is recommended for patients with intermediate stenoses. However, concerns exist with this approach in anatomically prognostic disease.
Methods:
In this prospective, multicentre study, we consecutively enrolled patients found to have FFR negative lesions in anatomically significant sites: left main; proximal LAD; last remaining patent vessel; and multiple vessels with concomitant impaired left ventricular systolic function (EF < 40%). As per recommendation, revascularisation was deferred, and patients included into a registry. The primary endpoint was MACE (death, myocardial infarction and unplanned target lesion revascularization). Secondary endpoints were the above individual components. Subgroup analyses were performed for clinical presentation (stable vs. ACS), localization of lesion (ostial vs. non ostial) and renal function.
Results:
The registry included 292 patients with 297 deferred stenoses. After 1-year, the primary endpoint occurred in 5% of patients, mainly driven by TLR (2.7%). Cardiovascular death occurred in 0.8% and AMI in 0.8%. During a follow-up of 22.2 ± 11 months, MACE occurred in 11.6%. Cardiovascular death occurred in 1.8% and AMI in 2.1%. After multivariate analysis, impaired renal function (OR 1.99; CI 95% 1.74-5.41; p = 0.046) and ostial disease (OR 2.88; CI 95% 1.04-7.38; p = 0.041) were found to be predictors of MACE. Impaired renal function also predicted TLR (OR 2.43; CI 95% 1.17-5.02; p = 0.017).
Conclusion:
FFR-guided revascularisation deferral is safe in the majority of anatomically prognostic disease. However, further evaluation is required in the risk stratification of those patients with ostial disease and renal disease. Registered on ClinicalTrials, NCT02590926.
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