In a randomized trial of imaging-guided or angiography-guided PCI for complex coronary lesion revascularization procedures, imaging-guided PCI led to a lower risk of target-vessel failure than ...angiography-guided PCI.
Although the presence of ischemia is a key prognostic factor in patients with coronary artery disease, the presence of high-risk plaque characteristics (HRPC) is also associated with increased risk ...of cardiovascular events. Limited data exist regarding the prognostic implications of combined information on physiological stenosis severity assessed by fractional flow reserve (FFR) and plaque vulnerability by coronary computed tomography angiography (CTA)–defined HRPC.
The current study aimed to evaluate the: 1) association between physiological stenosis severity and coronary CTA-defined HRPC; and 2) prognostic implications of coronary CTA-defined HRPC according to physiological stenosis severity in patients with coronary artery disease.
A total of 772 vessels (299 patients) evaluated by both coronary CTA and FFR were analyzed. The presence and number of HRPC (minimum lumen area <4 mm2, plaque burden ≥70%, low attenuating plaque, positive remodeling, napkin-ring sign, or spotty calcification) were assessed using coronary CTA images. The risk of vessel-oriented composite outcome (VOCO) (a composite of vessel-related ischemia-driven revascularization, vessel-related myocardial infarction, or cardiac death) at 5 years was compared according to the number of HRPC and FFR categories.
The proportion of lesions with ≥3 HRPC was significantly decreased according to the increase in FFR values (58.6%, 46.5%, 36.8%, 15.7%, and 3.5% for FFR ≤0.60, 0.61 to ≤0.70, 0.71 to ≤0.80, 0.81 to ≤0.90, and >0.90, respectively; overall p value <0.001). Both FFR and number of HRPC showed significant association with the estimated risk of VOCO (p = 0.008 and p = 0.023, respectively). In the FFR >0.80 group, lesions with ≥3 HRPC showed significantly higher risk of VOCO than those with <3 HRPC (15.0% vs. 4.3%; hazard ratio: 3.964; 95% confidence interval: 1.451 to 10.828; p = 0.007). However, there was no significant difference in the risk of VOCO according to HRPC in the FFR ≤0.80 group. By multivariable analysis, the presence of ≥3 HRPC was independently associated with the risk of VOCO in the FFR >0.80 group.
Physiological stenosis severity and the number of HRPC were closely related, and both components had significant association with the risk of clinical events. However, the prognostic implication of HRPC was different according to FFR. Integration of both physiological stenosis severity and plaque vulnerability would provide better prognostic stratification of patients than either individual component alone, especially in patients with FFR >0.80. (Clinical Implication of 3-vessel Fractional Flow Reserve 3V FFR-FRIENDS study; NCT01621438)
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Objectives This study examined the performance of percent aggregate plaque volume (%APV), which represents cumulative plaque volume as a function of total vessel volume, by coronary computed ...tomography angiography (CTA) for identification of ischemic lesions of intermediate stenosis severity. Background Coronary lesions of intermediate stenosis demonstrate significant rates of ischemia. Coronary CTA enables quantification of luminal narrowing and %APV. Methods We identified 58 patients with intermediate lesions (30% to 69% diameter stenosis) who underwent invasive angiography and fractional flow reserve. Coronary CTA measures included diameter stenosis, area stenosis, minimal lumen diameter (MLD), minimal lumen area (MLA) and %APV. %APV was defined as the sum of plaque volume divided by the sum of vessel volume from the ostium to the distal portion of the lesion. Fractional flow reserve ≤0.80 was considered diagnostic of lesion-specific ischemia. Area under the receiver operating characteristic curve and net reclassification improvement (NRI) were also evaluated. Results Twenty-two of 58 lesions (38%) caused ischemia. Compared with nonischemic lesions, ischemic lesions had smaller MLD (1.3 vs. 1.7 mm, p = 0.01), smaller MLA (2.5 vs. 3.8 mm2 , p = 0.01), and greater %APV (48.9% vs. 39.3%, p < 0.0001). Area under the receiver operating characteristic curve was highest for %APV (0.85) compared with diameter stenosis (0.68), area stenosis (0.66), MLD (0.75), or MLA (0.78). Addition of %APV to other measures showed significant reclassification over diameter stenosis (NRI 0.77, p < 0.001), area stenosis (NRI 0.63, p = 0.002), MLD (NRI 0.62, p = 0.001), and MLA (NRI 0.43, p = 0.01). Conclusions Compared with diameter stenosis, area stenosis, MLD, and MLA, %APV by coronary CTA improves identification, discrimination, and reclassification of ischemic lesions of intermediate stenosis severity.
Abstract Background The prognostic impact of microvascular status in patients with high fractional flow reserve (FFR) is not clear. Objectives The goal of this study was to investigate the ...implications of coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) in patients who underwent FFR measurement. Methods Patients with high FFR (>0.80) were grouped according to CFR (≤2) and IMR (≥23 U) levels: group A, high CFR with low IMR; group B, high CFR with high IMR; group C, low CFR with low IMR; and group D, low CFR with high IMR. Patient-oriented composite outcome (POCO) of any death, myocardial infarction, and revascularization was assessed. The median follow-up was 658 days (interquartile range: 503.8 to 1,139.3 days). Results A total of 313 patients (663 vessels) were assessed with FFR, CFR, and IMR. Correlation ( r = 0.201; p < 0.001) and categorical agreement (kappa value = 0.178; p < 0.001) between FFR and CFR were modest. Low CFR was associated with higher POCO than high CFR (p = 0.034). There were no significant differences in clinical and angiographic characteristics among groups. Patients with high IMR with low CFR had the highest POCO (p = 0.002). Overt microvascular disease (p = 0.008), multivessel disease (p = 0.033), and diabetes mellitus (p = 0.033) were independent predictors of POCO. Inclusion of a physiological index significantly improved the discriminant function of a predictive model (relative integrated discrimination improvement 0.467 p = 0.037; category-free net reclassification index 0.648 p = 0.007). Conclusions CFR and IMR improved the risk stratification of patients with high FFR. Low CFR with high IMR was associated with poor prognosis. (Clinical, Physiological and Prognostic Implication of Microvascular Status; NCT02186093 )
The authors investigated the utility of noninvasive hemodynamic assessment in the identification of high-risk plaques that caused subsequent acute coronary syndrome (ACS).
ACS is a critical event ...that impacts the prognosis of patients with coronary artery disease. However, the role of hemodynamic factors in the development of ACS is not well-known.
Seventy-two patients with clearly documented ACS and available coronary computed tomographic angiography (CTA) acquired between 1 month and 2 years before the development of ACS were included. In 66 culprit and 150 nonculprit lesions as a case-control design, the presence of adverse plaque characteristics (APC) was assessed and hemodynamic parameters (fractional flow reserve derived by coronary computed tomographic angiography FFRCT, change in FFRCT across the lesion △FFRCT, wall shear stress WSS, and axial plaque stress) were analyzed using computational fluid dynamics. The best cut-off values for FFRCT, △FFRCT, WSS, and axial plaque stress were used to define the presence of adverse hemodynamic characteristics (AHC). The incremental discriminant and reclassification abilities for ACS prediction were compared among 3 models (model 1: percent diameter stenosis %DS and lesion length, model 2: model 1 + APC, and model 3: model 2 + AHC).
The culprit lesions showed higher %DS (55.5 ± 15.4% vs. 43.1 ± 15.0%; p < 0.001) and higher prevalence of APC (80.3% vs. 42.0%; p < 0.001) than nonculprit lesions. Regarding hemodynamic parameters, culprit lesions showed lower FFRCT and higher △FFRCT, WSS, and axial plaque stress than nonculprit lesions (all p values <0.01). Among the 3 models, model 3, which included hemodynamic parameters, showed the highest c-index, and better discrimination (concordance statistic c-index 0.789 vs. 0.747; p = 0.014) and reclassification abilities (category-free net reclassification index 0.287; p = 0.047; relative integrated discrimination improvement 0.368; p < 0.001) than model 2. Lesions with both APC and AHC showed significantly higher risk of the culprit for subsequent ACS than those with no APC/AHC (hazard ratio: 11.75; 95% confidence interval: 2.85 to 48.51; p = 0.001) and with either APC or AHC (hazard ratio: 3.22; 95% confidence interval: 1.86 to 5.55; p < 0.001).
Noninvasive hemodynamic assessment enhanced the identification of high-risk plaques that subsequently caused ACS. The integration of noninvasive hemodynamic assessments may improve the identification of culprit lesions for future ACS. (Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamic EMERALD; NCT02374775)
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This study aimed to compare and evaluate the efficacy of the blood pressure (BP) control and cholesterol‐lowering effects and safety of combination therapy with telmisartan, rosuvastatin, and ...ezetimibe versus rosuvastatin and ezetimibe double therapy or telmisartan single therapy in dyslipidemia patients with hypertension. After a wash‐out/therapeutic lifestyle change period of ≥4 weeks, a total of 100 eligible patients were randomized and received one of three treatments for 8 weeks: (1) telmisartan 80 mg/rosuvastatin 20 mg/ezetimibe 10 mg (TRE), (2) rosuvastatin 20 mg/ezetimibe 10 mg (RE), or (3) telmisartan 80 mg (T). The primary endpoint was the efficacy evaluation of TRE by comparing changes in mean sitting systolic blood pressure (msSBP) and mean percentage change in low‐density lipoprotein‐C (LDL‐C) from baseline after 8 weeks of treatment.
The least square (LS) mean (SE) changes in msSBP at 8 weeks compared with baseline were −23.02 (3.04) versus −7.18 (3.09) mmHg in the TRE and RE groups, respectively (p < .0001), and −25.80 (2.74) versus −14.92 (2.65) mmHg in the TRE and T groups, respectively (p = .0005). The percentage changes in the mean (SD) LDL‐C at 8 weeks compared with baseline were −54.97% (3.49%) versus −0.17% (3.23%) in the TRE and T groups, respectively (p < .0001). No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups.
TRE therapy significantly decreased msSBP and LDL‐C compared to RE or T therapy with comparable safety and tolerability profiles.
Abstract Objectives This study investigated the role of fractional myocardial mass (FMM), a vessel-specific myocardial mass, in the evaluation of physiological severity of stenosis. Using computed ...tomography angiography, the study investigated fractional myocardial mass, a concept of myocardial mass subtended by specific vessel, which could reduce anatomical-physiological mismatch. Background Discordance between anatomical stenosis and physiological severity is common but remains poorly understood. Methods This multicenter study enrolled 463 patients with 724 lesions, who underwent coronary computed tomography angiography (CCTA) and invasive coronary angiography with fractional flow reserve (FFR) measurement. FMM was assessed by allometric scaling analysis of arterial tree length and myocardial mass from CCTA. Results FFR <0.80, a criteria for vessel-specific physiological stenosis, was found in 281 vessels (39%). FMM decreased consistently according to the vessel downstream (p < 0.001, all). The frequency of FFR <0.80 increased in proportion to FMM and inverse proportion to angiographic minimal luminal diameter (MLD) (p < 0.001). In per-vessel analysis, FMM per MLD (FMM/MLD) showed good correlation with FFR (r = 0.61) and was superior to diameter stenosis (DS) for FFR <0.80 by receiver operating characteristic and reclassification analysis (C-statistics = 0.84 versus 0.74, net reclassification improvement NRI = 0.63, integrated discrimination improvement IDI = 0.18; p < 0.001, all). The optimal cutoff of FMM/MLD was 29 g/mm, with sensitivity = 75%, specificity = 77%, positive predictive value = 68%, negative predictive value = 83%, and accuracy = 77%. Addition of FMM/MLD to DS could further discriminate vessels with FFR <0.80 (C-statistic = 0.86 vs. 0.84, NRI = 0.34, IDI = 0.03; p < 0.005, all). In per-range classification analysis, agreement between FFR and FMM/MLD maintained >80% when the severity of disease was away from cutoff. Conclusions FMM/MLD could find physiological severity of coronary artery with higher accuracy than anatomical stenosis. FMM may explain the anatomical-physiological discordance.
The aim of this study was to determine the diagnostic performance of a new method for quantifying fractional flow reserve (FFR) with computational fluid dynamics (CFD) applied to coronary computed ...tomography angiography (CCTA) data in patients with suspected or known coronary artery disease (CAD).
Measurement of FFR during invasive coronary angiography is the gold standard for identifying coronary artery lesions that cause ischemia and improves clinical decision-making for revascularization. Computation of FFR from CCTA data (FFR(CT)) provides a noninvasive method for identifying ischemia-causing stenosis; however, the diagnostic performance of this new method is unknown.
Computation of FFR from CCTA data was performed on 159 vessels in 103 patients undergoing CCTA, invasive coronary angiography, and FFR. Independent core laboratories determined FFR(CT) and CAD stenosis severity by CCTA. Ischemia was defined by an FFR(CT) and FFR ≤0.80, and anatomically obstructive CAD was defined as a CCTA with stenosis ≥50%. Diagnostic performance of FFR(CT) and CCTA stenosis was assessed with invasive FFR as the reference standard.
Fifty-six percent of patients had ≥1 vessel with FFR ≤0.80. On a per-vessel basis, the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 84.3%, 87.9%, 82.2%, 73.9%, 92.2%, respectively, for FFR(CT) and were 58.5%, 91.4%, 39.6%, 46.5%, 88.9%, respectively, for CCTA stenosis. The area under the receiver-operator characteristics curve was 0.90 for FFR(CT) and 0.75 for CCTA (p = 0.001). The FFR(CT) and FFR were well correlated (r = 0.717, p < 0.001) with a slight underestimation by FFR(CT) (0.022 ± 0.116, p = 0.016).
Noninvasive FFR derived from CCTA is a novel method with high diagnostic performance for the detection and exclusion of coronary lesions that cause ischemia.
In this trial involving 2492 patients, coronary revascularization guided by iFR, as compared with fractional flow reserve-guided revascularization, was within the prespecified margin for ...noninferiority with respect to major adverse cardiac events.
For the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization,
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but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis.
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FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI).
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Consequently, FFR is now included in the appropriate-use criteria for . . .
Objectives This study sought to determine whether computational modeling can be used to predict the functional outcome of coronary stenting by virtual stenting of ischemia-causing stenoses identified ...on the pre-treatment model. Background Computed tomography (CT)-derived fractional flow reserve (FFR) is a novel noninvasive technology that can provide computed (FFR ct ) using standard coronary CT angiography protocols. Methods We prospectively enrolled 44 patients (48 lesions) who had coronary CT angiography before angiography and stenting, and invasively measured FFR before and after stenting. FFR ct was computed in blinded fashion using coronary CT angiography and computational fluid dynamics before and after virtual coronary stenting. Virtual stenting was performed by modification of the computational model to restore the area of the target lesion according to the proximal and distal reference areas. Results Before intervention, invasive FFR was 0.70 ± 0.14 and noninvasive FFR ct was 0.70 ± 0.15. FFR after stenting and FFR ct after virtual stenting were 0.90 ± 0.05 and 0.88 ± 0.05, respectively (R = 0.55, p < 0.001). The mean difference between FFR ct and FFR was 0.006 for pre-intervention (95% limit of agreement: –0.27 to 0.28) and 0.024 for post-intervention (95% limit of agreement: –0.08 to 0.13). Diagnostic accuracy of FFR ct to predict ischemia (FFR ≤0.8) prior to stenting was 77% (sensitivity: 85.3%, specificity: 57.1%, positive predictive value: 83%, and negative predictive value: 62%) and after stenting was 96% (sensitivity: 100%, specificity: 96% positive predictive value: 50%, and negative predictive value: 100%). Conclusions Virtual coronary stenting of CT-derived computational models is feasible, and this novel noninvasive technology may be useful in predicting functional outcome after coronary stenting. (Virtual Coronary Intervention and Noninvasive Fractional Flow Reserve FFR; NCT01478100 )
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