Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)– and fractional flow reserve (FFR)–guided revascularization strategies. Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038

Clinical Events After Deferral of LAD Revascularization Following Physiological Coronary Assessment

BACKGROUND Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p ¼ 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p ¼ 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p ¼ 0.06). CONCLUSIONS iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). // Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. // Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. // Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). // Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year

Beam compression of multistatic intravascular ultrasound data by an adaptive kernel function

International audienc

Validation of coronary flow reserve measurements by thermodilution in clinical practice.

Contains fulltext : 59099.pdf (publisher's version ) (Closed access)BACKGROUND: Coronary flow reserve (CFR) and fractional flow reserve (FFR) provide complementary information on the coronary circulation. Using a pressure wire, it is possible to calculate CFR by thermodilution (CFR(thermo)), so that FFR and CFR can be measured with a single guide wire. The present multicentric study was performed to compare the feasibility of CFR(thermo)obtained with an improved algorithm and a standardized injection technique and its agreement with Doppler-derived CFR (CFR(Doppler)). METHODS AND RESULTS: In 86 patients with coronary artery disease recruited during 1 week in eight centres FFR, CFR(thermo)and CFR(Doppler)were measured. FFR could be obtained in all patients (100%). An optimal CFR(Doppler)could be obtained in 69% of the patients. CFR(thermo)could be obtained in 97% of the patients. A significant correlation was found between CFR(Doppler)and CFR(thermo)(r=0.79, P<0.0001) but CFR(thermo)tended to be higher than CFR(Doppler). CONCLUSIONS: In a setting close to 'real world' practice, this multicentric study confirms the feasibility and reliability of thermodilution-derived CFR. In addition, the safety and the swiftness of assessing FFR and CFR with one single guide wire makes the latter a unique clinical tool for the evaluation of the coronary circulation

Validation of coronary flow reserve measurements by thermodilution in clinical practice.

BACKGROUND: Coronary flow reserve (CFR) and fractional flow reserve (FFR) provide complementary information on the coronary circulation. Using a pressure wire, it is possible to calculate CFR by thermodilution (CFR(thermo)), so that FFR and CFR can be measured with a single guide wire. The present multicentric study was performed to compare the feasibility of CFR(thermo)obtained with an improved algorithm and a standardized injection technique and its agreement with Doppler-derived CFR (CFR(Doppler)). METHODS AND RESULTS: In 86 patients with coronary artery disease recruited during 1 week in eight centres FFR, CFR(thermo)and CFR(Doppler)were measured. FFR could be obtained in all patients (100%). An optimal CFR(Doppler)could be obtained in 69% of the patients. CFR(thermo)could be obtained in 97% of the patients. A significant correlation was found between CFR(Doppler)and CFR(thermo)(r=0.79, P<0.0001) but CFR(thermo)tended to be higher than CFR(Doppler). CONCLUSIONS: In a setting close to 'real world' practice, this multicentric study confirms the feasibility and reliability of thermodilution-derived CFR. In addition, the safety and the swiftness of assessing FFR and CFR with one single guide wire makes the latter a unique clinical tool for the evaluation of the coronary circulation