In a registry-based trial, FFR-guided PCI of nonculprit lesions did not result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than ...culprit-lesion-only PCI.
CONTEXT Coronary computed tomographic (CT) angiography is a noninvasive anatomic test for diagnosis of coronary stenosis that does not determine whether a stenosis causes ischemia. In contrast, ...fractional flow reserve (FFR) is a physiologic measure of coronary stenosis expressing the amount of coronary flow still attainable despite the presence of a stenosis, but it requires an invasive procedure. Noninvasive FFR computed from CT (FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), but its ability to identify ischemia has not been adequately examined to date. OBJECTIVE To assess the diagnostic performance of FFRCT plus CT for diagnosis of hemodynamically significant coronary stenosis. DESIGN, SETTING, AND PATIENTS Multicenter diagnostic performance study involving 252 stable patients with suspected or known CAD from 17 centers in 5 countries who underwent CT, invasive coronary angiography (ICA), FFR, and FFRCT between October 2010 and October 2011. Computed tomography, ICA, FFR, and FFRCT were interpreted in blinded fashion by independent core laboratories. Accuracy of FFRCT plus CT for diagnosis of ischemia was compared with an invasive FFR reference standard. Ischemia was defined by an FFR or FFRCT of 0.80 or less, while anatomically obstructive CAD was defined by a stenosis of 50% or larger on CT and ICA. MAIN OUTCOME MEASURES The primary study outcome assessed whether FFRCT plus CT could improve the per-patient diagnostic accuracy such that the lower boundary of the 1-sided 95% confidence interval of this estimate exceeded 70%. RESULTS Among study participants, 137 (54.4%) had an abnormal FFR determined by ICA. On a per-patient basis, diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of FFRCT plus CT were 73% (95% CI, 67%-78%), 90% (95% CI, 84%-95%), 54% (95% CI, 46%-83%), 67% (95% CI, 60%-74%), and 84% (95% CI, 74%-90%), respectively. Compared with obstructive CAD diagnosed by CT alone (area under the receiver operating characteristic curve AUC, 0.68; 95% CI, 0.62-0.74), FFRCT was associated with improved discrimination (AUC, 0.81; 95% CI, 0.75-0.86; P < .001). CONCLUSION Although the study did not achieve its prespecified primary outcome goal for the level of per-patient diagnostic accuracy, use of noninvasive FFRCT plus CT among stable patients with suspected or known CAD was associated with improved diagnostic accuracy and discrimination vs CT alone for the diagnosis of hemodynamically significant CAD when FFR determined at the time of ICA was the reference standard.
Background No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was ...superior to angiographic guidance alone in complex lesions. Methods Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. Results The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. Conclusions A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.
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 )
Abstract Objectives This study evaluated the association between atherosclerotic plaque characteristics (APCs) by coronary computed tomographic angiography (CTA), and lesion ischemia by fractional ...flow reserve (FFR). Background FFR is the gold standard for determining lesion ischemia. Although APCs by CTA—including aggregate plaque volume % (%APV), positive remodeling (PR), low attenuation plaque (LAP), and spotty calcification (SC)—are associated with future coronary syndromes, their relationship to lesion ischemia is unclear. Methods 252 patients (17 centers, 5 countries; mean age 63 years; 71% males) underwent coronary CTA, with FFR performed for 407 coronary lesions. Coronary CTA was interpreted for <50% and ≥50% stenosis, with the latter considered obstructive. APCs by coronary CTA were defined as: 1) PR, lesion diameter/reference diameter >1.10; 2) LAP, any voxel <30 Hounsfield units; and 3) SC, nodular calcified plaque <3 mm. Odds ratios (OR) and net reclassification improvement of APCs for lesion ischemia, defined by FFR ≤0.8, were analyzed. Results By FFR, ischemia was present in 151 lesions (37%). %APV was associated with a 50% increased risk of ischemia per 5% additional APV. PR, LAP, and SC were associated with ischemia, with a 3 to 5 times higher prevalence than in nonischemic lesions. In multivariable analyses, a stepwise increased risk of ischemia was observed for 1 (OR: 4.0, p < 0.001) and ≥2 (OR: 12.1, p < 0.001) APCs. These findings were APC dependent, with PR (OR: 5.3, p < 0.001) and LAP (OR: 2.1, p = 0.038) associated with ischemia, but not SC. When examined by stenosis severity, PR remained a predictor of ischemia for all lesions, whereas %APV and LAP were associated with ischemia for only ≥50%, but not for <50%, stenosis. Conclusions %APV and APCs by coronary CTA improve identification of coronary lesions that cause ischemia. PR is associated with all ischemia-causing lesions, whereas %APV and LAP are only associated with ischemia-causing lesions ≥50%. (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography; NCT01233518 )
Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one ...trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI.
The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) – is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint.
This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.
Coronary lesions of intermediate severity often cause ischemia, and fractional flow reserve (FFR)-guided revascularization for these coronary lesions is safe and effective. FFR derived from coronary ...computed tomography (FFRCT ) is a noninvasive method for diagnosis of lesion-specific ischemia, but its performance for intermediate stenoses has not been examined to date. We examined the performance of FFRCT versus FFR at the time of invasive angiography in 66 vessels of 60 patients who were identified as having an intermediate stenosis, defined by quantitative coronary angiographic percent diameter stenosis 40% to 69%. Ischemia for FFRCT and FFR was defined as ≤0.80. Diagnostic performance of FFRCT was determined compared to an invasive FFR standard. Mean age of the study group was 63.5 ± 8.1 years (81% men). Thirty-one patients (47%) demonstrated ischemia with an FFR ≤0.80, with 2 of 16 (12.5%), 21 of 37 (56.8%), and 8 of 13 (61.5%) lesions of 40% to 49%, 50% to 59%, and 60% to 69% stenosis causal of ischemia, respectively. At an FFR ≤0.80 cutoff for lesion-specific ischemia, accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of FFRCT were 86.4%, 90.3%, 82.9%, 82.4%, and 90.6%, respectively, with an area under the receiver operator characteristics curve of 0.95 (p <0.001) and good correlation to FFR (0.60, p <0.0001). No biases between FFRCT and FFR were noted by Bland–Altman analysis (0.03 ± 0.12, p = 0.054). In conclusion, FFRCT is a novel noninvasive method for diagnosis of lesion-specific ischemia of coronary lesions of intermediate stenosis severity.
In the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON), patients with an acute myocardial infarction with ST-segment elevation ...underwent percutaneous coronary intervention with either a sirolimus-eluting stent or an uncoated stent. The use of the sirolimus-eluting stent was associated with significant reductions in the rate of target-vessel failure and the severity of in-stent late luminal loss.
Patients with an acute myocardial infarction underwent percutaneous coronary intervention with either a sirolimus-eluting stent or an uncoated stent. The use of the sirolimus-eluting stent was associated with significant reductions in the rate of target-vessel failure and the severity of in-stent late luminal loss.
The use of sirolimus-eluting coronary-artery stents significantly reduces the incidence of restenosis after percutaneous coronary intervention (PCI), as compared with the use of uncoated stents.
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However, most randomized trials evaluating sirolimus-eluting stents have excluded patients with acute myocardial infarction with ST-segment elevation. Small series of patients with acute myocardial infarction have shown that the implantation of a sirolimus-eluting stent is associated with a low rate of restenosis.
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In the Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent vs. Abciximab and Bare-Metal Stent in Myocardial Infarction (STRATEGY) trial, the use of sirolimus-eluting stents reduced cardiovascular events, as compared with the . . .
Background and objectives: Myocardial perfusion imaging with cardiac single-photon emission tomography (SPECT) is widely available for the detection of coronary artery disease (CAD) with high ...diagnostic and prognostic accuracy for women. A large proportion of symptomatic women with true myocardial perfusion defects in SPECT referred to coronary angiography have an absence of CAD—a condition named INOCA (ischemia with nonobstructive CAD). Additionally, the INOCA endotypes are rarely correctly diagnosed, and therefore, no tailored therapy is prescribed. Materials and methods: The cardiac SPECT for women was performed from 2018 to 2021. Patients with perfusion defect were analyzed according to further prescribed diagnostic tests used to diagnose CAD. According to the diagnostic criteria, patients with INOCA were selected as candidates for invasive microvascular physiology measurements. The correlation was calculated between SPECT results and clinical characteristics, symptoms, and risk factors. Results: A total of 726 women with suspected CAD were analyzed. True myocardial perfusion defects were detected in 125 patients (17.2%). During coronary angiography in 70 (56.0%) women, atherosclerosis in epicardial arteries was not observed. In 17 (20.9%) patients, obstructive CAD was present. Correlation was found between perfusion defect in SPECT and cardiovascular risk factors, including overweight, obesity, arterial hypertension, and dyslipidemia. Women with typical angina were more likely to have INOCA, but with “noncardiac” symptoms—CAD. In total, 68 female patients met three inclusion criteria for INOCA and were selected as candidates for invasive diagnostic testing. Conclusions: The created registry proves the important role of cardiac SPECT and great need for the development of invasively detected physiological measurements. The combination of both interventions could significantly change the future directions for INOCA patients, improving treatment strategies and clinical outcomes, especially knowing the number of risk factors and varying clinical presentation. The study will be continued by performing invasive testing of coronary microvascular function to expand the competence about what is known about INOCA patients.
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