Two-year outcomes of endovascular therapy for femoropopliteal arterial lesions for patients with high bleeding risk.

The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for femoropopliteal arterial lesions has not been thoroughly investigated. The study population comprised 165 patients undergoing initial EVT for femoropopliteal lesions between June 2018 and June 2020. They were divided into two groups according to the ARC-HBR criteria. The primary end point was a composite of all-cause death, Bleeding Academic Research Consortium type 3 or 5 bleeding, and target lesion revascularization (TLR) within 2 years of EVT. The 165 patients were divided into two groups: 125 (75.8%) patients at HBR (HBR group) and 40 (24.2%) patients at no HBR (non-HBR group). The cumulative incidence of the primary endpoint was significantly higher in the HBR group than in the non-HBR group (40.6% vs. 0%, log-rank p < 0.001). The HBR group had a significantly higher risk of all-cause death, major bleeding, and TLR than the non-HBR group (25.2% vs. 0%, log-rank p = 0.004, 13.9% vs. 0%, log-rank p = 0.047, 16.8% vs. 0%, log-rank p = 0.035). Most patients with peripheral artery disease were classified as HBR patients, and HBR patients were at higher risk of death, major bleeding, and TLR than non-HBR patients.

Fifteen-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation.

BACKGROUND: Clinical outcomes after percutaneous coronary intervention have improved with the use of drug-eluting stents, but data beyond 10 years are limited. The purpose of this study was to evaluate the clinical outcomes of patients undergoing sirolimus-eluting stent implantation with follow-up beyond 10 years and to determine the impact of clinical and angiographic characteristics on long-term prognosis.Methods and Results: The clinical outcomes of 885 patients who had undergone sirolimus-eluting stent implantation at a single institution were retrospectively reviewed. Primary endpoints included in the analysis were clinically driven target lesion revascularization (cTLR) and target lesion revascularization (TLR). Univariate and multivariate nominal logistic regression was used for data analysis. The incidence rates of cTLR and TLR beyond 10 years after sirolimus-eluting stent implantation were 16.4% and 36.8%, respectively, with cTLR tending to decrease beyond 10 years. Acute coronary syndrome was a predominant trigger for cTLR. Age, statin use, and stent restenosis emerged as predictors of cTLR within 10 years, but no significant predictors other than age were identified beyond 10 years. CONCLUSIONS: Events continue to occur beyond 10 years after sirolimus-eluting stent implantation, with a trend toward an increase in acute coronary syndromes. It is important to be vigilant about the occurrence of acute coronary syndromes during long-term follow-up.

Comparison and Validation of Long-Term Bleeding Events for Academic Bleeding Risk (ARC-HBR) Criteria and Contemporary Risk Scores for Percutaneous Coronary Intervention With a Second-Generation Drug Eluting Stent.

BACKGROUND: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined a consensus clinical criterion for patients at HBR undergoing percutaneous coronary intervention (PCI). This study aimed to validate and compare the ARC-HBR criteria and the contemporary risk score for long-term bleeding outcomes using a cohort of patients undergoing PCI.Methods and Results: This study analyzed 3,410 patients who underwent PCI between 2010 and 2013. The endpoint was defined as incidence of The Bleeding Academic Research Consortium 3 or 5 bleeding events. In addition to ARC-HBR, this study validated the predictability of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score, Patterns of non-adherence to Anti-platelet Regimens In Stented patients (PARIS) bleeding score, and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) bleeding scores for bleeding events. There was a trend toward an increase in bleeding events, as the risk score increased for all bleeding risk scores used in this study. The ARC-HBR criteria had higher diagnostic sensitivity for bleeding events than other bleeding risk scores. CONCLUSIONS: Patients with a higher number of risk factors in each of the four bleeding risk scores had a higher risk of long-term bleeding events. In comparison to other contemporary risk scores, the ARC-HBR criteria were more sensitive in the identification of patients with bleeding events in the long-term.

Comparison of original and modified Academic Research Consortium for High Bleeding Risk definitions in real-world practice.

BACKGROUND: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined high bleeding risk (HBR) in patients undergoing percutaneous coronary intervention. We have reported a simplified HBR (S-HBR), excluding six items with prevalences under 1% from ARC-HBR. The Japanese Circulation Society developed an HBR specific to Japanese (J-HBR), adding three items to ARC-HBR in consideration of ethnicity. Data comparing each HBR are scarce. METHODS: Patients treated with second-generation drug-eluting stents between January 2010 and December 2013 were enrolled, in whom all items of ARC-HBR, and the incidences of major bleeding and ischemic events were examined. Also, the diagnostic values of ARC-HBR, S-HBR, and J-HBR at 1 and 7 years post procedure were compared by using receiver-operating characteristic curves. RESULTS: The study sample consisted of 3430 patients. Mean follow-up period was 2299 ±â€¯904 days. The incidence of major bleeding at 1 and 7 years in each definition was as follows: ARC-HBC, 3.3% and 10.6%; S-HBR, 3.3% and 10.7%; and J-HBR, 2.9% and 10.0%. The diagnostic value of J-HBR for major bleeding at 1 year was lower than that of ARC-HBR (C statistics 0.64 vs. 0.68, p < 0.001). Other diagnostic values of S-HBR and J-HBR were comparable to those of ARC-HBR. CONCLUSIONS: S-HBR was as useful as ARC-HBR in predicting both short- and long-term HBR, and J-HBR is useful for predicting long-term HBR.

Feasibility and safety of coronary catheterization with the distal radial approach for hemodialysis patients.

BACKGROUND: The distal radial approach (DRA) has been proposed as an alternative approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). However, its outcomes in hemodialysis (HD) patients have not been well studied in detail. We aimed to determine the feasibility and safety of coronary intervention with the DRA for HD patients. METHODS: We performed CAG or PCI with the DRA in 2500 consecutive patients between October 2018 and February 2020. The patients included 98 HD patients (HD group) and 2402 non-HD patients (non-HD group). The primary endpoints were the rates of procedural success and puncture site-related complications. The secondary endpoints were puncture site-related complications one year after the procedure. As a subanalysis, we also compared the outcomes on the basis of CAG and PCI. RESULTS: The procedural success rates were similar in the HD and non-HD groups (80.6% vs. 82.6%, p = 0.61 for the entire cohort; 78.3% vs. 80.9%, p = 0.58 for CAG; and 86.2% vs. 88.0%, p = 0.78 for PCI). The bleeding complications rates were low and there was no difference between groups (6.1% vs. 4.1%, p = 0.33 for the entire cohort; 0% vs. 2.2%, p = 0.21 for CAG; and 20.7% vs. 10.3%, p = 0.079 for PCI). Radial artery occlusion occurred in only one patient in the HD group after the procedure. CONCLUSIONS: Although modified hemostasis methods could be necessary for HD patients undergoing PCI, coronary intervention with the DRA is feasible and safe for both HD and non-HD patients.

Gastrointestinal and Intracranial Bleeding Events After Second-Generation Drug-Eluting Stent Implantation　- Their Association With High Bleeding Risk, Predictors, and Clinical Outcomes.

BACKGROUND: Gastrointestinal bleeding (GIB) and intracranial bleeding (ICB) are frequently observed as major bleeding events after percutaneous coronary intervention (PCI); however, there are few reports on these predictors and their association with the Academic Research Consortium for High Bleeding Risk (ARC-HBR).Methods and Results: The study included 3,453 patients who underwent PCI with second-generation drug-eluting stents between 2010 and 2013. Mean follow up was 2,663±596 days. The cumulative incidences of GIB and ICB were significantly higher in the HBR group than in the non-HBR group (6.3% vs. 1.9%, P<0.001, 5.5% vs. 2.3%, P<0.001). Older age, oral anticoagulant (OAC), and severe chronic kidney disease were independent predictors of GIB (hazard ratios [HR], 1.64; 95% confidence intervals [CI], 1.11-2.41; P=0.012; HR, 1.94; 95% CI, 1.23-3.05; P=0.004; HR, 1.80; 95% CI, 1.02-3.19, P=0.043 respectively), and low body weight, OAC, and left main coronary artery stenting were independent predictors of ICB by multivariate logistic regression analysis (HR, 1.83; 95% CI, 1.20-2.80; P=0.005; HR, 2.04; 95% CI, 1.31-3.19; P=0.002; HR, 1.79; 95% CI, 1.18-2.70; P=0.006 respectively). CONCLUSIONS: ARC-HBR was consistently associated with GIB and ICB within a 7-year period. GIB and ICB had three predictors each. Of these, only OAC administration was common, and the other two were different.

Delayed stenosis regression after drug-coated balloon angioplasty for femoropopliteal artery lesions.

Paclitaxel has the potential for inducing lumen enlargement by vessel enlargement, healing of dissection, and plaque regression. This study was carried out to determine the possibility of and the relevant factors of delayed stenosis regression after drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) artery lesions. A total 105 de novo FP lesions were finalized with DCB angioplasty in our institute between May 2018 and June 2020. Among them, cases in which residual stenosis was detected by duplex ultrasonography (DUS) after the procedure were included in this study. Significant stenosis was defined as peak systolic velocity ratio ≥ 2.4 by DUS. Follow-up DUS was routinely performed 6 months after the procedure, and we defined cases without stenosis as cases of delayed stenosis regression according to the follow-up DUS. DUS showed that 26 (25.5%) of 102 lesions had residual stenosis after DCB angioplasty, and delayed stenosis regression was observed in 12 (57.1%) of 21 lesions 6 months after the procedure. The percentage of lesions containing calcified plaque as detected by intravascular ultrasound analysis was significantly higher in the non-regression group than in the regression group (18.2% vs. 77.8%, p = 0.02). Vessel remodeling and dissection patterns were not associated with delayed stenosis regression. The results of our analyses indicate that delayed stenosis regression may occur after DCB angioplasty for FP lesions in more than half of cases with residual stenosis. Delayed stenosis regression may be difficult in cases of calcified lesions.

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events.

BACKGROUND: The validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definitions of early (<1 year), late (1-4 years), and very late (>4 years) bleeding events is unknown.Methods and Results:This study was performed on patients (n=3,453) implanted with second-generation drug-eluting stents (DES) between 2010 and 2013. Data on all criteria of the ARC-HBR definition were collected retrospectively. The primary endpoint was Bleeding Academic Research Consortium Type 3 or 5 bleeding events; the ischemic endpoint was a composite of cardiac death, myocardial infarction, and ischemic stroke. The mean follow-up period was 7.5 years. Compared with non-high bleeding risk (HBR) patients, HBR patients (n=1,840; 53.3%) had an increased risk of the primary endpoint (early events, 3.6% vs. 0.5% [P<0.0001]; late events, 5.3% vs. 2.5% [P<0.0001]; very late events, 5.5% vs. 2.1% [P<0.0001]) and of ischemic events during follow-up. The discrimination ability of the ARC-HBR definition for late and very late bleeding events was comparable to that of early bleeding events (C statistics 0.679, 0.621, and 0.620, respectively) with high negative predictive value (96.6%, 95.1%, and 93.1%, respectively). Multivariate analysis revealed the different effects of individual criteria on bleeding events in each follow-up period. CONCLUSIONS: The ARC-HBR definition consistently identified patients at risk of long-term bleeding and ischemic events after second-generation DES implantation.

Impact of Guidewire Route on Severe Dissection After Balloon Angioplasty for Femoropopliteal Chronic Total Occlusion Lesions: An Intravascular Ultrasound Analysis.

OBJECTIVE: To determine the impact of the guidewire route on severe dissection after balloon angioplasty for femoropopliteal chronic total occlusion (CTO) lesions using a new intravascular ultrasound (IVUS) assessed classification scheme corresponding to a conventional angiographic classification scheme. METHODS: Images for 21 femoropopliteal CTO lesions treated endovascularly between May 2018 and December 2019 were used for analysis. IVUS images after guidewire passage and those after balloon angioplasty were evaluated at 1 cm intervals. Cross sectional images were obtained (n = 219) and divided into two groups by the guidewire route: those in which the guidewire passed through the inner half of the luminal radius (central wiring group, 139 cross sectional images) and those in which the guidewire passed through the outer half of the luminal radius (eccentric wiring group, 80 cross sectional images). Angiographically severe dissection was defined as Type C or greater according to the National Heart, Lung, and Blood Institute classification, to which six dissection morphology patterns were applied based on IVUS images (Types A - E2). RESULTS: Central wiring was achieved in an average of 69.6 ± 28.0% of the CTO length from per limb analysis. Among the IVUS assessed dissection morphology patterns, Types D - E2 were more frequently correlated with angiographically severe dissection than were Types A - C (57.5% vs. 13.7%, p < .001). Multivariable analysis showed that soft plaque was a predictive factor for (odds ratio [OR] 2.14; 95% confidence interval [CI] 1.007 - 4.72; p = .048) and central wiring was a protective factor (OR 0.27; 95% CI 0.14 - 0.49; p < .001) against Type D - E2 dissection patterns assessed by IVUS after balloon angioplasty. CONCLUSION: Lesions with Type D - E2 dissection patterns assessed by IVUS were correlated with angiographically severe dissection. Central wiring may be useful for preventing severe dissection after balloon angioplasty for femoropopliteal CTO lesions.

Impact of ischemic risk factors on long-term outcomes in patients with and without high bleeding risk.

Background The current guidelines have recommended to shorten the dual antiplatelet therapy duration in patients at high bleeding risk (HBR) to minimize the bleeding complications. The impact of ischemic risk factors (IRF) on long-term ischemic events in patients with and without HBR after percutaneous coronary intervention remains unclear. Methods The study population comprised 1219 patients who were treated with everolimus-eluting stents between 2010 and 2011. The mean follow-up period was 2996 ± 433 days. HBR was defined as set by the Academic Research Consortium. IRF was defined as high-risk features of stent-driven recurrent ischemic events endorsed in the 2017 European Society of Cardiology Guidelines. Major bleeding was defined as the occurrence of Bleeding Academic Research Consortium type 3 or 5 bleeding. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. Results The 1219 patients were divided into two groups: 614 patients at HBR (HBR group) and 605 patients at no HBR (non-HBR group). The rate of IRF patients was significantly higher in the HBR group than in the non-HBR group (81.4% versus 47.6%, P < 0.001). The cumulative rate of ischemic events in the HBR group was significantly higher in IRF patients than in non-IRF patients (21.0% versus 7.0%, log rank P < 0.001), whereas that in the non-HBR group was not significantly different between IRF and non-IRF patients (10.1% versus 6.3%, log rank P = 0.09). Conclusions More than 80% of HBR patients treated with everolimus-eluting stents were at IRF. A combination of HBR and IRF may increase the risk of long-term ischemic events.

Impact of high-dose statin on cardiovascular outcomes in real-world patients with ST-elevation acute myocardial infarction.

Little is known about the impact of a high-dose statin on cardiovascular outcomes after ST-elevation acute myocardial infarction (STEMI) in real-world Japanese patients. Between July 2011 and June 2017, 1110 consecutive STEMI patients underwent primary percutaneous coronary intervention at our hospital and were discharged. A high-dose statin was administered in 117 patients (10.5%) and non-high-dose statin was administered in 947 patients (85.3%). The low-density lipoprotein cholesterol level was significantly higher in the high-dose statin group at admission (129.8 ± 44.9 vs. 110.4 ± 32.7, p < 0.0001), but the levels were not significantly different at follow-up (86.7 ± 25.7 vs. 85.0 ± 25.0, p = 0.52). The cumulative 2-year incidence of a composite of cardiac death, myocardial infarction, ischemic stroke, and any unplanned coronary revascularization was significantly lower in the high-dose statin group (6.2% vs. 16.9%, log-rank p = 0.004). Propensity score matched analysis indicated similar results. Among the types of coronary revascularization, a high-dose statin was significantly correlated with a lower rate of de novo lesion revascularization (hazard ratio 0.31; 95% confidence interval 0.08-0.83; p = 0.02). The results of our analyses indicate that administration of a high-dose statin may result in better cardiovascular outcomes after STEMI mainly by reducing the rate of revascularization for de novo lesions regardless of the achieved low-density lipoprotein cholesterol level in real-world patients.

Iliac May-Thurner syndrome coexisting with arteriovenous fistula treated by endovascular therapy.

An 82-year-old woman presented with persistent left leg swelling despite 3 months anticoagulation for deep vein thrombosis. Ultrasound showed venous blood flowing back into the toe. Enhanced computed tomography scans and angiography showed occlusion of the left common iliac vein and a large number of arteriovenous fistulas. We made a diagnosis of May-Thurner syndrome coexisting with arteriovenous fistulas and we performed endovascular therapy only for the common iliac vein. We considered embolization for arteriovenous fistulas, but it seemed to be difficult to perform because of the possibility of development of collateral circulation and a large number of arteriovenous fistulas. After percutaneous balloon angioplasty, antegrade venous blood flow was restored, and stent implantation was not performed. After the procedure, swelling of the leg gradually reduced. She had no symptoms for the following 1 year.

C-Peptide Area Under the Curve at Glucagon Stimulation Test Predicts Glucose Improvements by GLP-1 Receptor Analogue: A Retrospective Observational Study.

INTRODUCTION: Despite the widespread use of glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1ras) to improve glycemic regulation, with a low risk of hypoglycemia and weight reduction, their effectiveness varies among individuals. This study aimed to identify predictors of the efficacy of GLP-1ra on Hemoglobin A1c (HbA1c) in patients with insulin-independent diabetes. METHODS: In total, 58 patients with insulin-independent diabetes were included. Patients were included if their ß-cell function was evaluated via a glucagon stimulation test (GST) before the introduction of GLP-1ra therapy. ß-Cell function-related indices, such as the C-peptide index (CPI), increments in C-peptide immunoreactivity (CPR) after glucagon stimulation (ΔCPR), and the area under the CPR curve (CPR-AUC) during the GST, were evaluated. HbA1c and body weight (BW) were measured at 6 and 12 months after the initiation of GLP-1ra. RESULTS: A univariate regression analysis revealed a significant correlation between CPR-AUC and changes in HbA1c at 6 months and with changes in BW at 6 and 12 months. A multivariate regression analysis revealed that CPR-AUC was significantly correlated with changes in HbA1c at 6 months. A receiver-operating characteristic analysis revealed that 21.9 ng/ml·min CPR-AUC was the optimal cut-off value to predict an HbA1c level < 7%, i.e., 53 mmol/mol. CONCLUSION: Residual ß-cell function, as assessed via CPR-AUC in the GST, is an effective predictor of the efficacy of GLP-1ras.

Nutritional investigation of non-obese patients with non-alcoholic fatty liver disease: the significance of dietary cholesterol.

OBJECTIVE: The onset and progression of non-alcoholic fatty liver disease (NAFLD) seem to be affected by nutritive intake; however, detailed examinations have not been performed in non-obese NAFLD patients. The purpose of this study was to identify potential nutritive factors that affect NAFLD and its related nutritional problems. MATERIAL AND METHODS: We investigated the distribution of abdominal fat, dietary intake, and biochemical data in patients with NAFLD and compared non-obese with obese patients. RESULTS: There was no significant difference in the percentage of patients with diabetes or dyslipidemia between the obese and non-obese groups. Waist circumference, total abdominal fat levels, and subcutaneous fat levels were significantly higher in the obese group, while visceral fat levels were not significantly different between the two groups. Immunoreactive insulin (IRI) and homeostasis model assessment-insulin resistance (HOMA-IR) were significantly lower in the non-obese group, suggesting that the non-obese patients were not overtly insulin resistant. Although serum adiponectin and TNF-alpha levels were similar in both groups, leptin levels were significantly higher in the obese group. Total energy and carbohydrate intake tended to be higher in the obese group. A characteristic feature was that dietary cholesterol intake was significantly higher, while the intake of polyunsaturated fatty acids (PUFAs) was significantly lower in the non-obese group. CONCLUSIONS: In non-obese NAFLD patients: 1) although visceral fat was increased, insulin resistance and/or dysregulated secretion of adipocytokines was not necessarily shown; 2) intakes of total energy and carbohydrates were not excessive, although dietary cholesterol was superabundant and dietary PUFAs were significantly lower compared with those in obese patients; and 3) characteristic fat intake may be associated with the formation of NAFLD.

Sloughing off of a cervical myoma after cesarean section: a case report.

BACKGROUND: Occasionally a submucous myoma is sloughed off during the puerperium, but it is seldom that the initial location of the myoma is identified before its expulsion. CASE: A 32-year-old, nulliparous woman with a cervical myoma underwent an elective cesarean section at 37 weeks. At surgery a cervical myoma was identified as not endophytic to the intrauterine cavity but exophytic to the uterine exterior and was left without any intervention. Part of the cervical myoma was sloughed off into the vagina after 16 days, and an abdominal myomectomy was performed for a refractory infection. CONCLUSION: Comparison with analogous cases following intervention indicates that myoma degeneration due to blood supply depletion, uterine contractions and endometrial sparseness must be important factors in this phenomenon. When these conditions are met, a shallow, intramural myoma could be sloughed off in the puerperium.

[Comparative analysis of learning effect for students who experienced both lecture-based learning and problem-based learning in a complete denture course].

PURPOSE: The purpose of this study was to analyze the difference in educational effect on students who experienced both lecture-based learning (LBL) and problem-based learning (PBL) in a complete denture course. The analysis focused on differences between the two methods concerning self study, ability to understand clinical inference, and appraisal of class contents and tutors. METHODS: In the complete denture preclinical course, the class of 2003 received LBL in 3rd grade and PBL in 4th grade. PBL was planned to present five cases in five consecutive classes. Group discussion was carried out for each case, and a summary was required to be produced two times as a group, two times as an individual report and one time by group presentation. A questionnaire regarding the educational effect of LBL and PBL and assessment of tutors was administered. Factor analysis was carried out to classify the questionnaire items and each item was analyzed between LBL and PBL (Paired-t test). RESULTS: Factor analysis revealed that the questionnaire items could be classified into four components. Comparing lecture type and PBL: "study attitude" (4 out of 7 items), "clinical inference ability" (all items), "class contents" (5 out of 7 items) and "tutor appraisal" (2 out of 5 items) showed significant assessment with PBL. Eighteen of 27 items (66.6%) indicated the significant usefulness of PBL. CONCLUSION: PBL improves the educational effect of self study and clinical inference ability, in comparison with LBL. However, since students are passive about taking the same system class repeatedly, a strategy to improve their attitude needs to be considered.