The Absorb GT1 Bioresorbable Vascular Scaffold System　- 5-Year Post-Market Surveillance Study in Japan.

BACKGROUND: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

Impact of minimum contrast media volumes during percutaneous coronary intervention for chronic total occlusion lesion.

Contrast media exposure is associated with contrast-induced nephropathy (CIN) following percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Aim of this study is to assess the utility of minimum contrast media volume (CMV ≤ 50 mL) during CTO-PCI for CIN prevention in patients with chronic kidney disease (CKD). We extracted data from the Japanese CTO-PCI expert registry; 2863 patients with CKD who underwent CTO-PCI performed from 2014 to 2020 were divided into two groups: minimum CMV (n = 191) and non-minimum CMV groups (n = 2672). CIN was defined as an increased serum creatinine level of ≥ 25% and/or ≥ 0.5 mg/dL compared with baseline levels within 72 h of the procedure. In the minimum CMV group, the CIN incidence was lower than that in the non-minimum CMV group (1.0% vs. 4.1%; p = 0.03). Patient success rate was higher and complication rate was lower in the minimum CMV group than in the non-minimum CMV group (96.8% vs. 90.3%; p = 0.02 and 3.1% vs. 7.1%; p = 0.03). In the minimum CMV group, the primary retrograde approach was more frequent in the case of J-CTO = 1,2 and 3-5 groups compared to that in non-minimum CMV-PCI group (J-CTO = 0; 11% vs. 17.7%, p = 0.06; J-CTO = 1; 22% vs. 35.8%, p = 0.01; J-CTO = 2; 32.4% vs. 46.5%, p = 0.01; and J-CTO = 3-5; 44.7% vs. 80.0%, p = 0.02). Minimum CMV-PCI for CTO in CKD patients could reduce the incidence of CIN. The primary retrograde approach was observed to a greater extent in the minimum CMV group, especially in cases of difficult CTO.

Procedural results and in-hospital outcomes of percutaneous coronary intervention for chronic total occlusion in patients with reduced left ventricular ejection fraction: Sub-analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: To evaluate the procedural results and in-hospital outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients with reduced left ventricular ejection fraction (LVEF). BACKGROUND: While the technical success of general CTO-PCI has improved, CTO-PCI patients with reduced LVEF remain at high-risk for adverse events. METHODS: The data of 820 patients with LVEF ≤ 35% (Group 1), 1816 patients with LVEF = 35%-50% (Group 2), and 5503 patients with LVEF ≥ 50% (Group 3), registered in the Japanese CTO-PCI Expert Registry from January 2014 to December 2019, were retrospectively analyzed. The primary endpoint was in-hospital major adverse cardiac or cerebrovascular events (MACCEs), including death, myocardial infarction, stent thrombosis, stroke, and emergent revascularization. Secondary endpoints included procedural details, guidewire success, and technical success. RESULTS: There were no differences in guidewire and technical success rates between the groups. In-hospital MACCEs was significantly higher in Group 1 (Group 1 vs. Group 2 vs. Group 3: 3.4% vs. 1.7% vs. 1.5%, p = 0.001) and was especially driven by death (1.3% vs. 0.3% vs. 0.1%, p < 0.001) and stroke (0.7% vs. 0.2% vs. 0.2%, p = 0.007). Multivariate analysis showed that LVEF ≤ 35% (odds ratio [OR]; 1.58, 95% confidence interval [CI]; 1.04-2.41, p = 0.03) and New York Heart Association (NYHA) class ≥ 3 (OR; 2.01, 95% CI; 1.03-3.93, p = 0.04) were predictors of in-hospital MACCEs. CONCLUSIONS: In-hospital MACCEs were significantly higher in patients with LVEF ≤ 35%. LVEF ≤;35% and NYHA class ≥ 3 were predictors of in-hospital MACCEs after CTO-PCI.

The diagnostic performance of on-site workstation-based computed tomography-derived fractional flow reserve. Comparison with myocardium perfusion imaging.

To compare the diagnostic performance of on-site workstation-based computed tomography-derived fractional flow reserve (CT-FFR)Few data of CT-FFR were reported regarding the diagnostic performance for detecting hemodynamically significant coronary artery disease (CAD). This retrospective single-center analysis included 132 vessels in 77 patients who underwent CT angiography, myocardial perfusion imaging (MPI), and invasive FFR. The correlation coefficient between CT-FFR and invasive FFR and optimal cut-off value for CT-FFR to identify invasive FFR ≤ 0.8 were evaluated. The diagnostic accuracies of CT- FFR, and MPI were evaluated using an area under the receiver-operating characteristic curve (AUC) with invasive FFR as a reference standard. Diagnostic performance of CT-FFR was also evaluated concerning lesion characteristics, including intermediate lesions, left main lesions, tandem lesions, and/or diffuse lesions, and coronary calcium (Agatston score over 400). The Receiver Operating Characteristic curve analysis showed that the optimal cut-off value of CT-FFR for detecting invasive FFR ≤ 0.80 was 0.80 [AUC = 0.83, 95%CI: 0.76-0.90). Diagnostic sensitivity, specificity, positive and negative predictive value, and accuracy of CT-FFR when compared with those of MPI regarding per-patient analysis were 93% vs. 63%, 48% vs. 61%, 81% vs. 79%, 73% vs. 41%, and 79% vs. 62%, respectively, and for per-vessel analysis were 89% vs. 24%, 66% vs. 82%, 75% vs. 61%, 83% vs. 48%, and 78% vs. 51%, respectively. The AUC of the CT-FFR was significantly higher than MPI (0.83 vs. 0.57, p < 0.0001) regarding the per-vessel analysis. No differences in the diagnostic performance of CT-FFR were noted in the presence of intermediate lesions, left main lesions, tandem lesions, and/or diffuse lesions, and severe coronary calcium. On-site CT-FFR delivered a higher diagnostic performance than MPI for detecting CAD with invasive FFR ≤ 0.8, indicating the potential of CT-FFR as the gatekeeper of invasive coronary angiogram as well as percutaneous coronary intervention.

Predictors of prolonged guidewire manipulation time for native coronary chronic total occlusion percutaneous coronary intervention via primary antegrade approach.

OBJECTIVES: This study aimed to identify the predictive factors for the guidewire manipulation time (GWMT) of ≥20 and 30 min for chronic total occlusion-percutaneous coronary intervention (CTO-PCI) via the primary antegrade approach (PAA). BACKGROUND: Selection of primary retrograde approach (PRA) and the optimal timing to switch from antegrade to retrograde approach for coronary CTO-PCI is still debatable. METHODS: Using the Japanese CTO-PCI expert registry data, we selected and analyzed 4461 patients who underwent CTO-PCI via PAA alone. The considerable lesion/anatomical factors for GWMT ≥20 and 30 min were analyzed. The risks of prolonged GWMT ≥20 and 30 min were stratified as easy, intermediate, difficult, and very difficult according to the multivariate analysis. RESULTS: Nine lesion/anatomical characteristics (blunt stump, side branch at proximal cap, bifurcation at the exit point, calcification, tortuosity, occlusion length ≥ 20 mm, reattempt, nonleft anterior descending artery (nonleft anterior descending artery [LAD]), and tandem CTO) were independent predictors of GWMT ≥20 min (all p < 0.05). Excluding the nonLAD and tandem CTO, the same factors of GWMT ≥20 min correlated with GWMT ≥30 min (all p < 0.05). The distributions were increased in easy, intermediate, difficult, and very difficult subsets of GWMT ≥20 min (58.3%, 77.2%, 89.1%, and 100%) and GWMT ≥30 min (47.5%, 69.2%, 83.9%, and 100%). CONCLUSIONS: These predictive factors of prolonged GWMT should be assessed before CTO-PCI via PAA and when considering an adequate timing to switch the retrograde or PRA if clinically available.

Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement　- Primary Outcomes From the Japanese Disrupt CAD IV Study.

BACKGROUND: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance and optimize stent deployment. The objective of this study was to assess the safety and effectiveness of IVL treatment of de novo stenoses involving severely calcified coronary vessels in a Japanese population.Methods and Results:Disrupt CAD IV (NCT04151628) was a prospective, multicenter study designed for Japanese regulatory approval of coronary IVL (SWM-1234). The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days. The primary effectiveness endpoint was procedural success (residual stenosis <50% by QCA without in-hospital MACE). Noninferiority analyses for the primary endpoints were performed by comparing the CAD IV cohort with a propensity-matched historical IVL control group. Patients (intent-to-treat, n=64) were enrolled from 8 centers in Japan. Severe calcification by core laboratory assessment was present in all lesions, with a calcified length of 49.8±15.5 mm and a calcium angle of 257.9±78.4° by optical coherence tomography. Primary endpoints were achieved with non-inferiority demonstrated for freedom from 30-day MACE (CAD IV: 93.8% vs. Control: 91.2%, P=0.008), and procedural success (CAD IV: 93.8% vs. Control: 91.6%, P=0.007). No perforations, abrupt closures, or slow/no-reflow events occurred at any time during the procedures. CONCLUSIONS: Coronary IVL demonstrated high procedural success with low MACE rates in severely calcified lesions in a Japanese population.

Comparison of the catheter ablation outcome in patients between targeting the entrance and exit of the reentry circuit in verapamil-sensitive atrial tachycardia originating from the atrioventricular-node vicinity.

Verapamil-sensitive atrial tachycardia originating from the atrioventricular node vicinity (AVN-AT) can be eliminated with radiofrequency energy (RF) deliveries targeting either the entrance or exit of its reentry circuit. However, the outcome of these different approaches has not been clarified well. Thus, we compared the catheter ablation outcome targeting the entrance of reentry circuit, identified by the entrainment method (Ent-Group; 21 patients) with that targeting the earliest atrial activation site (EAAS) during AT (Exit-Group; 16 patients). There was no significant difference in the tachycardia cycle length (441.4 ± 87.4 vs. 392.8 ± 64.8 ms, p = 0.0704) or distance from the His bundle (HB) site to the EAAS (6.5 ± 2.0 vs. 7.6 ± 1.8 mm, p = 0.0822) between the Ent- and Exit-Groups. However, distance from the successful ablation site to the HB site in the Ent-Group was significantly longer than that in the Exit-Group (13.4 ± 3.1 vs. 7.6 ± 1.8 mm, p < 0.0001), resulting in more frequent transient atrioventricular block episodes in the Exit-Group than Ent-Group (31.3 vs. 0%, p < 0.01). Initial ATs (AT1s) were terminated in all patients in both Groups. However, ATs accompanied by shifting in the EAAS (AT2) were induced more frequently in the Exit-Group than Ent-Group (50.0 vs. 14.3%, p < 0.02) after eliminating AT1. RF deliveries to the EAAS eliminated all AT2s. The number of RF deliveries was greater in the Exit-Group than Ent-Group (6.9 ± 3.3 vs. 3.9 ± 1.6, p < 0.001). In conclusion, RF ablation targeting the entrance sites can avoid AVN injury and is superior in reducing the number of RF deliveries and occurrence of different ATs than targeting the exit sites in the AVN-AT.

Correction to: Three-dimensional assessment of coronary high-intensity plaques with T1-weighted cardiovascular magnetic resonance imaging to predict periprocedural myocardial injury after elective percutaneous coronary intervention.

In the original publication of this article [1] the wording of '3Di-PMR' was different between the text and figures.

Three-dimensional assessment of coronary high-intensity plaques with T1-weighted cardiovascular magnetic resonance imaging to predict periprocedural myocardial injury after elective percutaneous coronary intervention.

BACKGROUND: Periprocedural myocardial injury (pMI) is a common complication of elective percutaneous coronary intervention (PCI) that reduces some of the beneficial effects of coronary revascularization and impacts the risk of cardiovascular events. We developed a 3-dimensional volumetric cardiovascular magnetic resonance (CMR) method to evaluate coronary high intensity plaques and investigated their association with pMI after elective PCI. METHODS: Between October 2012 and October 2016, 141 patients with stable coronary artery disease underwent T1-weighted CMR imaging before PCI. A conventional 2-dimensional CMR plaque-to-myocardial signal intensity ratio (2D-PMR) and the newly developed 3-dimensional integral of PMR (3Di-PMR) were measured. 3Di-PMR was determined as the sum of PMRs above a threshold of > 1.0 for voxels in a target plaque. pMI was defined as high-sensitivity cardiac troponin T > 0.07 ng/mL. RESULTS: pMI following PCI was observed in 46 patients (33%). 3Di-PMR was significantly higher in patients with pMI than those without pMI. The optimal 3Di-PMR cutoff value for predicting pMI was 51 PMR*mm3 and the area under the receiver operating characteristic curve (0.753) was significantly greater than that for 2D-PMR (0.683, P = 0.015). 3Di-PMR was positively correlated with lipid volume (r = 0.449, P < 0.001) based on intravascular ultrasound. Stepwise multivariable analysis showed that 3Di-PMR ≥ 51 PMR*mm3 and the presence of a side branch at the PCI target lesion site were significant predictors of pMI (odds ratio [OR], 11.9; 95% confidence interval [CI], 4.6-30.4, P < 0.001; and OR, 4.14; 95% CI, 1.6-11.1, P = 0.005, respectively). CONCLUSIONS: 3Di-PMR coronary assessment facilitates risk stratification for pMI after elective PCI. TRIAL REGISTRATION: retrospectively registered.

Determinants of insufficient improvement in fractional flow reserve following percutaneous coronary intervention.

Fractional flow reserve (FFR) has become an increasingly important index for decision making concerning coronary revascularization. It is commonly accepted that significant improvement in FFR following percutaneous coronary intervention (PCI) is associated with better symptomatic relief and a lower event rate. However, in lesions with insufficient FFR improvement, PCI may not improve prognosis. Leading to the observation that the clinical and angiographic characteristics associated with insufficient FFR improvement have not been fully explored. The purpose of this study was to investigate the factors associated with insufficient improvement in FFR. Using our own PCI database, established between January 2014 and December 2018, we identified 220 stable coronary artery lesions, which had been evaluated for both pre- and post-PCI FFR values. All 220 of these lesions were included in this study. The improvement in FFR (ΔFFR) was calculated in each lesion with the lowest quartile of ΔFFR being defined as the lowest ΔFFR group, and the other quartiles being defined as the intermediate-high ΔFFR group. The mean ΔFFR in the lowest and intermediate-high ΔFFR groups was 0.07 ± 0.02 and 0.21 ± 0.11, respectively. In multivariate logistic regression analysis, a short total stent length (10 mm increase: OR 0.67, 95% CI 0.47-0.96, P = 0.030), higher pre-PCI FFR (0.1 increase: OR 4.07, 95% CI 1.83-9.06, P = 0.001), in-stent restenosis (ISR) (OR 8.02, 95% CI 1.26-51.09, P = 0.028), myocardial infarction (MI) in the target vessel (OR 6.87, 95% CI 1.19-39.69, P = 0.031) and non-use of intravascular imaging (OR 0.35, 95% CI 0.12-0.99, P = 0.048) were significantly associated with the lowest ΔFFR group. The use of short stents, higher pre-PCI FFR values, ISR, MI in the target vessel, and non-use of intravascular imaging were significantly associated with insufficient FFR improvement. It was conversely suggested that full coverage and adequate dilatation of the lesions under an intravascular imaging guidance might contribute to an improvement in FFR.

Clinical impact of successful recanalization for chronic total occlusion: insights from stress myocardial perfusion imaging.

The clinical benefits of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is still controversial. The purpose of this study is to assess the quantitative therapeutic benefits of successful PCI for CTO from the clinical data acquired by myocardial perfusion imaging (MPI). Consecutive 42 patients, who were successfully revascularized of CTO between August 2013 and March 2018, were examined. A stress MPI was performed before CTO PCI and at follow-up, and the changes in quantitative gated and perfusion single photon emission computed tomography parameters were examined. The follow-up interval was 18 ± 9 (median 14) months, during which 36 patients were maintained patency (patent CTO), while 6 were re-occluded (R/O CTO). The reduction in the % myocardial ischemia and the improvement in the ejection fraction were significantly higher in the patent CTO group than those in the R/O CTO group (67.5 ± 37.0% vs. - 56.4 ± 84.9%, p < 0.0001, 20.7 ± 49.8% vs. - 9.2 ± 20.6%, p = 0.0247, respectively). Interestingly, the improvements we observed were predominantly in the patients with LAD CTO rather than those with RCA or LCx CTO. Successful CTO PCI was able to reduce myocardial ischemia and improve the cardiac function when the patency after CTO PCI was maintained, with the most notable significance in the patients with LAD CTO.

Prasugrel effectively reduces the platelet reactivity units in patients with genetically metabolic dysfunction of cytochrome P450 2C19 who are treated with long-term dual antiplatelet therapy after undergoing drug-eluting stent implantation.

Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 inhibitor is administered following percutaneous coronary intervention (PCI) with coronary stent implantation. Several studies have reported the effects of switching between P2Y12 inhibitors on platelet reactivity (P2Y12 reaction units: PRU), from acute to late phase after PCI. However, the effect of switching at very late phase is unknown. This study examined the effect on PRU in Japanese coronary heart disease patients with long-term DAPT (aspirin + clopidogrel) when switching from clopidogrel to prasugrel. Ninety-six patients were enrolled in this study. The median DAPT duration at enrollment was 1824.0 days. Twenty-three patients with PRU ≥ 208 at enrollment were randomly assigned into either continuing to receive clopidogrel (Continued Group; n = 11) or switching to prasugrel (Switched Group; n = 12). The primary endpoint was the rate of patients who achieved PRU < 208 at the end of 12 weeks of treatment, which was significantly higher in Switched Group relative to Continued Group (90.0% vs. 36.4%; P = 0.024). The secondary endpoint was the PRU at week 12 in groups subdivided according to cytochrome P450 (CYP) 2C19 genotypes. At week 12, extensive metabolizers (EM Group) had 202.3 ± 60.0 and 174.5 ± 22.3 in Continued Group and Switched Group (P = 0.591), respectively; intermediate and poor metabolizers (non-EM Group) had 229.4 ± 36.9 and 148.4 ± 48.4 in Continued Group and Switched Group (P = 0.002), respectively. The PRU for non-EM Group was significantly reduced in Switched Group. Thus, for patients with long-term DAPT (aspirin + clopidogrel) after PCI with coronary stent implantation, switching from clopidogrel to prasugrel resulted in a stable reduction in PRU, regardless of CYP2C19 polymorphism.

Assessment of reattempted percutaneous coronary intervention strategy for chronic total occlusion after prior failed procedures: Analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: We aimed to investigate strategies for reattempted percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs) by highly skilled operators after a failed attempt. BACKGROUND: Development of complex techniques and algorithms has been standardized for CTO-PCI. However, there is no appropriate strategy for CTO-PCI after a failed procedure. METHOD: From 2014 to 2016, the Japanese CTO-PCI Expert Registry included 4,053 consecutive CTO-PCIs (mean age: 66.8 ± 10.9 years; male: 85.6%; Japanese CTO [J-CTO] score: 1.92 ± 1.15). Initial outcomes and strategies for reattempted CTO-PCIs were evaluated and compared with first-attempt CTO-PCIs. RESULTS: Reattempt CTO-PCIs were performed in 820 (20.2%) lesions. The mean J-CTO score of reattempt CTO-PCIs was higher than that of first-attempt CTO-PCIs (2.86 ± 1.03 vs. 1.68 ± 1.05, p < .001). The technical success rate of reattempt CTO-PCIs was lower than that of first-attempt CTO-PCIs (86.7% vs. 90.8%, p < .001). Regarding successful CTO-PCIs, the strategies comprised antegrade alone (reattempt: 36.1%, first attempt: 63.8%), bidirectional approach (reattempt: 54.4%, first attempt: 30.3%), and antegrade approach following a failed bidirectional approach (reattempt: 9.4%, first attempt: 5.4%). Parallel wire technique, intravascular ultrasound guide crossing, and bidirectional approach technique were frequently performed in reattempt CTO-PCIs. Reattempt CTO-PCIs showed higher rates of myocardial infarction (2.1% vs. 0.9%, p < .001) and coronary perforation (6.9% vs. 4.2%, p = .002) than first-attempt CTO-PCIs. CONCLUSIONS: The technical success rate of reattempt CTO-PCIs is lower than that of first-attempt CTO-PCIs. However, using more complex strategies, the success rate of reattempt CTO-PCI can be improved by highly skilled operators.

Clinical Impact of Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve on Japanese Population in the ADVANCE Registry.

BACKGROUND: Coronary computed tomography angiography (cCTA)-derived fractional flow reserve (FFRCT) is a promising diagnostic method for the evaluation of coronary artery disease (CAD). However, clinical data regarding FFRCTin Japan are scarce, so we assessed the clinical impact of using FFRCTin a Japanese population.Methods and Results:The ADVANCE registry is an international prospective FFRCTregistry of patients suspected of CAD. Of 5,083 patients, 1,829 subjects enrolled from Japan were analyzed. Demographics, symptoms, cCTA, FFRCT, treatment strategy, and 90-day major cardiovascular events (MACE) were assessed. Reclassification of treatment strategy between cCTA alone and cCTA+FFRCToccurred in 55.8% of site investigations and in 56.9% in the core laboratory analysis. Patients with positive FFR (FFRCT≤0.80) were less likely to have non-obstructive disease on invasive coronary angiography than patients with negative FFR (FFRCT>0.80) (20.5% vs. 46.1%, P=0.0001). After FFRCT, 67.0% of patients with positive results underwent revascularization, whereas 96.1% of patients with negative FFRCTwere medically treated. MACE occurred in 5 patients with positive FFRCT, but none occurred in patients with negative FFRCTwithin 90 days. CONCLUSIONS: In this Japanese population, FFRCTmodified the treatment strategy in more than half of the patients. FFRCTshowed potential for stratifying patients suspected of CAD properly into invasive or non-invasive management pathways.

Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry.

Aims: Non-invasive assessment of stable chest pain patients is a critical determinant of resource utilization and clinical outcomes. Increasingly coronary computed tomography angiography (CCTA) with selective CCTA-derived fractional flow reserve (FFRCT) is being used. The ADVANCE Registry, is a large prospective examination of using a CCTA and FFRCT diagnostic pathway in real-world settings, with the aim of determining the impact of this pathway on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE). Methods and results: A total of 5083 patients with symptoms concerning for coronary artery disease (CAD) and atherosclerosis on CCTA were enrolled at 38 international sites from 15 July 2015 to 20 October 2017. Demographics, symptom status, CCTA and FFRCT findings, treatment plans, and 90 days outcomes were recorded. The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management plans occurred in 66.9% [confidence interval (CI): 64.8-67.6] of patients. Non-obstructive coronary disease was significantly lower in ICA patients with FFRCT ≤0.80 (14.4%) compared to patients with FFRCT >0.80 (43.8%, odds ratio 0.19, CI: 0.15-0.25, P < 0.001). In total, 72.3% of subjects undergoing ICA with FFRCT ≤0.80 were revascularized. No death/myocardial infarction (MI) occurred within 90 days in patients with FFRCT >0.80 (n = 1529), whereas 19 (0.6%) MACE [hazard ratio (HR) 19.75, CI: 1.19-326, P = 0.0008] and 14 (0.3%) death/MI (HR 14.68, CI 0.88-246, P = 0.039) occurred in subjects with an FFRCT ≤0.80. Conclusions: In a large international multicentre population, FFRCT modified treatment recommendation in two-thirds of subjects as compared to CCTA alone, was associated with less negative ICA, predicted revascularization, and identified subjects at low risk of adverse events through 90 days.

Characteristics of time-activity curves obtained from dynamic 11C-methionine PET in common primary brain tumors.

PURPOSE: The aim of this study was to assess whether dynamic PET with 11C-methionine (MET) (MET-PET) is useful in the diagnosis of brain tumors. METHODS: One hundred sixty patients with brain tumors (139 gliomas, 9 meningiomas, 4 hemangioblastomas and 8 primary central nervous system lymphomas [PCNSL]) underwent dynamic MET-PET with a 3-dimensional acquisition mode, and the maximum tumor MET-standardized uptake value (MET-SUV) was measured consecutively to construct a time-activity curve (TAC). Furthermore, receiver operating characteristic (ROC) curves were generated from the time-to-peak (TTP) and the slope of the curve in the late phase (SLOPE). RESULTS: The TAC patterns of MET-SUVs (MET-TACs) could be divided into four characteristic types when MET dynamics were analyzed by dividing the MET-TAC into three phases. MET-SUVs were significantly higher in early and late phases in glioblastoma compared to anaplastic astrocytoma, diffuse astrocytoma and the normal frontal cortex (P < 0.05). The SLOPE in the late phase was significantly lower in tumors that included an oligodendroglial component compared to astrocytic tumors (P < 0.001). When we set the cutoff of the SLOPE in the late phase to - 0.04 h-1 for the differentiation of tumors that included an oligodendroglial component from astrocytic tumors, the diagnostic accuracy was 74.2% sensitivity and 64.9% specificity. The area under the ROC curve was 0.731. CONCLUSIONS: The results of this study show that quantification of the MET-TAC for each brain tumor identified by a dynamic MET-PET study could be helpful in the non-invasive discrimination of brain tumor subtypes, in particular gliomas.

Effect of pioglitazone on cardiometabolic profiles and safety in patients with type 2 diabetes undergoing percutaneous coronary artery intervention: a prospective, multicenter, randomized trial.

Pioglitazone has superior antiatherosclerotic effects compared with other classes of antidiabetic agents, and there is substantial evidence that pioglitazone improves cardiovascular (CV) outcomes. However, there is also a potential risk of worsening heart failure (HF). Therefore, it is clinically important to determine whether pioglitazone is safe in patients with type 2 diabetes mellitus (T2DM) who require treatment for secondary prevention of CV disease, since they have an intrinsically higher risk of HF. This prospective, multicenter, open-label, randomized study investigated the effects of pioglitazone on cardiometabolic profiles and CV safety in T2DM patients undergoing elective percutaneous coronary intervention (PCI) using bare-metal stents or first-generation drug-eluting stents. A total of 94 eligible patients were randomly assigned to either a pioglitazone or conventional (control) group, and pioglitazone was started the day before PCI. Cardiometabolic profiles were evaluated before PCI and at primary follow-up coronary angiography (5-8 months). Pioglitazone treatment reduced HbA1c levels to a similar degree as conventional treatment (pioglitazone group 6.5 to 6.0%, P < 0.01; control group 6.5 to 5.9%, P < 0.001), without body weight gain. Levels of high-molecular weight adiponectin increased more in the pioglitazone group than the control group (P < 0.001), and the changes were irrespective of baseline glycemic control. Furthermore, pioglitazone significantly reduced plasma levels of natriuretic peptides and preserved cardiac systolic and diastolic function (assessed by echocardiography) without incident hospitalization for worsening HF. The incidence of clinical adverse events was also comparable between the groups. These results indicate that pioglitazone treatment before and after elective PCI may be tolerable and clinically safe and may improve cardiometabolic profiles in T2DM patients.

Acute effects of statin on reduction of angiopoietin-like 2 and glyceraldehyde-derived advanced glycation end-products levels in patients with acute myocardial infarction: a message from SAMIT (Statin for Acute Myocardial Infarction Trial).

Experimental ischemia-reperfusion models have shown that 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, statins, have cardioprotective effects. SAMIT (Statin Acute Myocardial Infarction Trial) is a multicenter prospective open randomized trial, designed to evaluate the effects of statin treatment from the earliest stage on cardioprotection in patients with acute myocardial infarction (AMI). Patients were randomly assigned to receive atorvastatin (initial dose of 40 mg at admission followed by the maintenance dose of 10 mg/day for 30 days) or not (control), and then immediately underwent percutaneous coronary intervention (PCI) for the culprit lesion. The primary endpoints were infarct size and left ventricular function. The secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) and various biomarkers. There were no significant differences in baseline characteristics between 2 groups of the statin treatment group and the control group. The left ventricular ejection fraction increased at 6 months after the onset of AMI, compared with the baseline level in the atorvastatin group (P < 0.05), while it did not change in the control group. Although there were no significant differences in the MACCE, the changes in the levels of angiopoietin-like protein 2 (ANGPTL2) (P < 0.05), and glyceraldehyde-derived advanced glycation end-products, (TAGE) (P < 0.01) were suppressed at 2 weeks in the atorvastatin group, compared with the control group. Statin therapy started early after the onset reduced the levels of ANGPTL2 and TAGE, and thus, might have cardioprotective effects in patients with AMI.

Myocardial Perfusion Imaging and Fractional Flow Reserve-Therapeutic Strategy Based on Myocardial Ischemia Evaluation in Patients with Coronary Artery Disease.

Indications for percutaneous coronary intervention (PCI) among patients with stable coronary artery disease (CAD) have historically been decided after morphological evaluation using coronary angiography (CAG). Recently, the importance of physiological evaluation has been recognized using either myocardial perfusion imaging (MPI) or fractional flow reserve (FFR). The results of the recent COURAGE trial showed that PCI did not improve mortality rates in medically optimized patients with stable CAD. However, a nuclear sub-study of that trial in which participants underwent MPI before and after PCI+ optimal medical therapy (OMT), found a greater reduction in ischemia compared with OMT alone. Moreover, the unadjusted risk for death or myocardial infarction in patients with ischemia reduction was lower. In contrast, the FAME study indicated that FFR-guided PCI improved the outcomes of patients with multi-vessel CAD compared with angiography-guided PCI. The FAME II study also indicated the validity of FFR-guided PCI. Thus, FFR evaluation of ischemia is becoming more popular worldwide from the viewpoint of intervention. Both MPI and FFR reflect physiological ischemia, but their findings do not necessarily match up. One reason is that MPI reflects myocardial ischemia whereas FFR reflects coronary artery ischemia. Thus, cardiologists regard the findings of these modalities conflicting when considering practicality and diagnostic accuracy. This article compares the features of MPI and FFR and discusses an appropriate strategy with which to evaluate CAD.