Five-Year Outcomes After Fractional Flow Reserve–Guided Deferral of Revascularization in Infarct-Related Artery Lesions
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SUBMITTER: Ohashi H
PROVIDER: S-EPMC11307784 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:Background Chronic kidney disease (CKD) might influence fractional flow reserve (FFR) value, potentially attenuating its prognostic utility. However, few large-scale data are available regarding clinical outcomes after FFR-guided deferral of revascularization in patients with CKD. Methods and Results From the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1218 patients were divided into 3 groups according to renal function: (1) non-CKD (estimated glomerular filtration rate ≥60 mL/min per 1.73 m2), n=385; (2) CKD (estimated glomerular filtration rate 15-59 mL/min per 1.73 m2, n=763); and (3) end-stage renal disease (ESRD) (eGFR <15 mL/min per 1.73 m2, n=70). The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinical driven target vessel revascularization. Cumulative 5-year incidence of TVF was significantly higher in the ESRD group than in the CKD and non-CKD group, whereas it did not differ between the CKD and non-CKD groups (26.3% versus 11.9% versus 9.5%, P<0.001). Although the 5-year TVF risk increased as the FFR value decreased regardless of renal function, patients with ESRD had a remarkably higher risk of TVF at every FFR value than those with CKD and non-CKD. Conclusions At 5 years, patients with ESRD showed a higher incidence of TVF than patients with CKD and non-CKD, although with similar outcomes between patients with CKD and non-CKD. Patients with ESRD had an excess risk of 5-year TVF at every FFR value compared with those with CKD and non-CKD. Registration URL: https://www.umin.ac.jp; Unique identifier: UMIN000014473.
| S-EPMC10757552 | biostudies-literature
Project description:BackgroundBecause the clinical benefit of antiplatelet therapy (APT) for patients with nonsignificant coronary artery disease (CAD) remains poorly understood, we evaluated it in patients after fractional flow reserve (FFR)-guided deferral of revascularization.Methods and resultsFrom the J-CONFIRM (Long-Term Outcomes of Japanese Patients with Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), we investigated 265 patients with deferred lesions who did not require APT for secondary prevention of cardiovascular disease. A 2-year landmark analysis assessed the relationship between APT at 2 years and 5-year major cardiac adverse events (MACE: composite of all-cause death, target vessel-related myocardial infarction, clinically driven target vessel revascularization). Of the 265 patients, 163 (61.5%) received APT. The 5-year MACE did not significantly differ between the APT and non-APT groups after adjustment for baseline clinical characteristics (9.2% vs. 6.9%, inverse probability weighted hazard ratio, 1.40 [95% confidence interval, 0.53-3.69]; P=0.49). There was a marginal interaction between the effect of APT on MACE and FFR values (< or ≥0.84) (P for interaction=0.066).ConclusionsThe 5-year outcomes after FFR-guided deferral of revascularization did not significantly differ between the APT and non-APT groups, suggesting that APT might not be a critical requirement for nonsignificant obstructive CAD patients not requiring APT for secondary prevention of cardiovascular disease.
| S-EPMC11309776 | biostudies-literature
Project description:Limited data are available regarding comparative prognosis after percutaneous coronary intervention (PCI) versus deferral of revascularization in patients with intermediate stenosis with abnormal fractional flow reserve (FFR) but preserved coronary flow reserve (CFR). From the International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713), a total of 330 patients (338 vessels) who had coronary stenosis with FFR ≤ 0.80 but CFR > 2.0 were selected for the current analysis. Patient-level clinical outcome was assessed by major adverse cardiac events (MACE) at 5 years, a composite of all-cause death, target-vessel myocardial infarction (MI), or target-vessel revascularization. Among the study population, 231 patients (233 vessels) underwent PCI and 99 patients (105 vessels) were deferred. During 5 years of follow-up, cumulative incidence of MACE was 13.0% (31 patients) without significant difference between PCI and deferred groups (12.7% vs. 14.0%, adjusted HR 1.301, 95% CI 0.611-2.769, P = 0.495). Multiple sensitivity analyses by propensity score matching and inverse probability weighting also showed no significant difference in patient-level MACE and vessel-specific MI or revascularization. In this hypothesis-generating study, there was no significant difference in clinical outcomes between PCI and deferred groups among patients with intermediate stenosis with FFR ≤ 0.80 but CFR > 2.0. Further study is needed to confirm this finding.Clinical Trial Registration: International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713; registration date: 10/01/2018).
| S-EPMC8080642 | biostudies-literature
Project description:Fractional flow reserve (FFR)-guided percutaneous coronary intervention has shown favorable long-term clinical outcomes. However, limited data exist evaluating the FFR assessment among the chronic kidney disease (CKD) population. The aim of this study was to evaluate the long-term clinical outcomes of FFR-guided coronary revascularization in patients with CKD. A total of 242 CKD patients who underwent FFR assessment were retrospectively analyzed. Patients were divided into two groups: revascularization (FFR ≤ 0.80) and non-revascularization (FFR > 0.80). The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel failure (TVF). The key secondary endpoint was TVF. The Cox regression model was used for risk evaluation. With 91% of the ischemic vessels revascularized, the revascularization group had higher risks for both the primary endpoint (adjusted hazard ratio [aHR]: 2.06; 95% confidence interval [CI], 1.07-3.97; p = 0.030) and key secondary endpoint (aHR: 2.19, 95% CI: 1.10-4.37; p = 0.026), during a median follow-up of 2.9 years. This result was consistent among different CKD severities. In patients with CKD, functional ischemia in coronary artery stenosis was associated with poor clinical outcomes despite coronary revascularization.
| S-EPMC8781197 | biostudies-literature
Project description:BackgroundDeferral of coronary revascularization is safe whether guided by instantaneous wave-free ratio (iFR) or by fractional flow reserve (FFR). We aimed to assess long-term outcomes in patients deferred from revascularization based on iFR or FFR in a large real-world population.MethodsFrom 2013 through 2017, 201,933 coronary angiographies were registered in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART). We included all patients (n = 11,324) with at least 1 coronary lesion deferred from PCI during an index procedure using iFR (>0.89; n = 1998) or FFR (>0.80; n = 9326). The primary outcome was major adverse cardiac events (MACE) defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. A multivariable-adjusted Cox proportional hazards model was used, with analysis for interaction of prespecified subgroups.ResultsPatients presented with stable angina pectoris (iFR 46.9% vs FFR 48.6%), unstable angina or non-ST-elevation myocardial infarction (iFR 37.7% vs FFR 33.1%), ST-elevation myocardial infarction (iFR 1.9% vs FFR 1.6%), and other indications (iFR 12.5% vs FFR 15.7%). The median follow-up was 2 years for both iFR and FFR groups. At the conclusion of the study, the cumulative MACE risks were 26.7 for the iFR group and 25.9% for FFR group. In the adjusted analysis, no difference was found between the 2 groups (adjusted hazard ratio: iFR vs FFR, 0.947; 95% CI, 0.84-1.08; P = 39). Consistent with the overall findings, the prespecified subgroups showed no interaction with the FFR/iFR results.ConclusionsDeferral of revascularization showed similar long-term safety whether based on iFR or on FFR.
| S-EPMC11307766 | biostudies-literature
Project description:IntroductionFractional flow reserve (FFR) is recommended by society guidelines for assessment of the hemodynamic significance of intermediate coronary lesions when non-invasive evidence of myocardial ischemia is unavailable. However, the prevalence of FFR usage in current practice and how FFR values impact revascularization decisions are not well known.MethodsAt a single-center Veterans Administration Hospital, all subjects referred for coronary angiography for any indication from the period from May 2012 until January 2014 were prospectively entered into a database. FFR was measured in all intermediate coronary lesions (30-70% stenosis). Based on the FFR results, the lesions were categorized into 3 different groups: FFR > 0.80 (non-ischemic), FFR 0.75-0.80 (gray zone), and FFR < 0.75 (ischemic).ResultsA total of 1482 cardiac catheterizations were performed during the study period. FFR was performed in 347 (23%) of these procedures. The total numbers of intermediate coronary lesions evaluated with FFR were 429. The mean FFR value was 0.79 (median = 0.80; interquartile range 0.64-0.96). Among 211 non-ischemic lesions, revascularization was deferred in 201 (95%). In the gray-zone group (73 lesions), 35 (48%) lesions were treated with percutaneous coronary intervention (PCI), 11 (15%) lesions were referred for coronary artery bypass grafting surgery (CABG), and 27 (37%) lesions were treated medically. In the ischemic group (145 lesions), 82 (57%) lesions were treated with PCI, 41 (28%) lesions were referred for CABG, and 22 (15%) lesions were treated medically.ConclusionAt a Veterans Administration Hospital, FFR was performed in approximately one out of four total catheterizations. FFR documented lack of ischemia in about half of the intermediate coronary lesions, and thus reduced the need for many revascularization procedures.
| S-EPMC4675752 | biostudies-literature
Project description:Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is recommended in revascularization guidelines for intermediate lesions. However, recent studies comparing FFR-guided PCI with non-physiology-guided revascularization have reported conflicting results. PubMed and Embase were searched for studies comparing FFR-guided PCI with non-physiology-guided revascularization strategies (angiography-guided, intracoronary imaging-guided, coronary artery bypass grafting). Data were pooled by meta-analysis using random-effects model. 26 studies enrolling 78,897 patients were included. FFR-guided PCI as compared to non-physiology-guided coronary revascularization had lower risk of all-cause mortality (odds ratio [OR] 0.79 95% confidence interval [CI] 0.64-0.99, I2 = 53%) and myocardial infarction (MI) (OR 0.74 95% CI 0.59-0.93, I2 = 44.7%). However, no differences between groups were found in terms of major adverse cardiac events (MACEs) (OR 0.86 95% CI 0.72-1.03, I2 = 72.3%) and repeat revascularization (OR 1 95% CI 0.82-1.20, I2 = 43.2%). Among patients with coronary artery disease (CAD), FFR-guided PCI as compared to non-physiology-guided revascularization was associated with a lower risk of all-cause mortality and MI.
| S-EPMC10371824 | biostudies-literature
Project description:ObjectivesThe aim was to assess long-term outcome after deferring intervention of coronary lesions with a fractional flow reserve (FFR) value of >0.80 in a real-world patient population and then to identify factors associated with deferred target lesion failure (DTLF).BackgroundDeferring coronary interventions of intermediate lesions based on FFR measurement is safe, irrespective of the extent of coronary artery disease. However, FFR values near the cut-off of >0.80 may have less favorable outcome.MethodsA retrospective analysis was performed in patients with deferred coronary intervention based on FFR value >0.80. The primary endpoint was DTLF, a composite of acute coronary syndrome (ACS) and any coronary revascularization, related to the initially deferred stenosis.ResultsA total of 600 patients, mean age of 66 ± 10 years, and 751 coronary lesions with negative FFR values (mean 0.88 ± 0.04) were included. The mean follow-up was 27 ± 15 months. DTLF occurred in 44 patients (7.3%), revascularization in 42 (7%), and ACS without revascularization in 2 patients (0.3%). Patients with DTLF more often had diabetes mellitus, previous coronary artery bypass grafting, multivessel disease (MVD), and lower FFR at inclusion. Multivariable regression analysis showed that lower deferred FFR values [FFR 0.81-0.85: hazard ratio (HR) 2.79 (95% CI [confidence interval]; 1.46-5.32), p .002], MVD [HR 1.98 (95% CI; 1.05-3.75), p .036], distal lesions [HR 2.43 (95% CI; 1.29-4.57), p .006], and lesions located in a saphenous vein graft (SVG) [HR 6.35 (95% CI; 1.81-22.28), p .004] were independent predictors for DTLF.ConclusionsThe long-term rate of DTLF of initially deferred coronary lesions was 7.3%. Independent predictors for DTLF are lower deferred FFR value, the presence of MVD, distal lesions, and lesions in SVG.
| S-EPMC7983981 | biostudies-literature
Project description:Assessing coronary physiology after stent implantation facilitates the optimisation of percutaneous coronary intervention (PCI). Coronary artery disease (CAD) patterns can be characterised by the pullback pressure gradient (PPG) index. The impact of focal vs. diffuse disease on physiology-guided incremental optimisation strategy (PIOS) is unknown. This is a sub-study of the TARGET-FFR randomized clinical trial (NCT03259815). The study protocol directed that optimisation be attempted for patients in the PIOS arm when post-PCI FFR was <0.90. Overall, 114 patients (n = 61 PIOS and 53 controls) with both pre-PCI fractional flow reserve (FFR) pullbacks and post-PCI FFR were included. A PPG ≥ 0.74 defined focal CAD. The PPG correlated significantly with post-PCI FFR (r = 0.43; 95% CI 0.26 to 0.57; p-value < 0.001) and normalised delta FFR (r = 0.49; 95% CI 0.34 to 0.62; p-value < 0.001). PIOS was more frequently applied to vessels with diffuse CAD (6% focal vs. 42% diffuse; p-value = 0.006). In patients randomized to PIOS, those with focal disease achieved higher post-PCI FFR than patients with diffuse CAD (0.93 ± 0.05 vs. 0.83 ± 0.07, p < 0.001). There was a significant interaction between CAD patterns and the randomisation arm for post-PCI FFR (p-value for interaction = 0.004). Physiology-guided stent optimisation was applied more frequently to vessels with diffuse disease; however, patients with focal CAD at baseline achieved higher post-PCI FFR.
| S-EPMC10417445 | biostudies-literature
Project description:Background An angiography-based supervised machine learning ( ML ) algorithm was developed to classify lesions as having fractional flow reserve ≤0.80 versus >0.80. Methods and Results With a 4:1 ratio, 1501 patients with 1501 intermediate lesions were randomized into training versus test sets. Between the ostium and 10 mm distal to the target lesion, a series of angiographic lumen diameter measurements along the centerline was plotted. The 24 computed angiographic features based on the diameter plot and 4 clinical features (age, sex, body surface area, and involve segment) were used for ML by XGBoost. The model was independently trained and tested by 2000 bootstrap iterations. External validation with 79 patients was conducted. Including all 28 features, the ML model with 5-fold cross-validation in the 1204 training samples predicted fractional flow reserve ≤0.80 with overall diagnostic accuracy of 78±4% (averaged area under the curve: 0.84±0.03). The 12 high-ranking features selected by scatter search were involved segment; body surface area; distal lumen diameter; minimal lumen diameter; length of a lumen diameter <2.0 mm, <1.5 mm, and <1.25 mm; mean lumen diameter within the worst segment; sex; diameter stenosis; distal 5-mm reference lumen diameter; and length of diameter stenosis >70%. Using those 12 features, the ML predicted fractional flow reserve ≤0.80 in the test set with sensitivity of 84%, specificity of 80%, and overall accuracy of 82% (area under the curve: 0.87). The averaged diagnostic accuracy in bootstrap replicates was 81±1% (averaged area under the curve: 0.87±0.01). External validation showed accuracy of 85% (area under the curve: 0.87). Conclusions Angiography-based ML showed good diagnostic performance in identifying ischemia-producing lesions and reduced the need for pressure wires.
| S-EPMC6405668 | biostudies-literature