Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention.

BACKGROUND: It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). OBJECTIVES: This study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years. METHODS: STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). RESULTS: Among 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31). CONCLUSIONS: Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.

Transcatheter arterial embolization of a type 2 endoleak through the dorsal pancreatic artery after the hybrid repair of a thoracoabdominal aortic aneurysm: A case report.

An 83-year-old woman with a history of hybrid repair of thoracoabdominal aortic aneurysm presented with enlargement of the aneurysm due to a type 2 endoleak from the celiac artery. The endoleak cavity was accessed via the dorsal pancreatic artery, and embolization using N-butyl cyanoacrylate and coils was successfully performed. When celiac artery branches are embolized during hybrid repair of a thoracoabdominal aortic aneurysm, attention should be paid to the dorsal pancreatic artery to appropriately determine which branches are to be embolized, because a nonembolized dorsal pancreatic artery may lead to type 2 endoleaks.

Development of pulmonary arterial hypertension following long-term Qing-Dai use for ulcerative colitis.

A 20-year-old woman using Qing-Dai for about 7 years for intractable ulcerative colitis was admitted to the emergency room because of dyspnea and syncope following exertion. The patient was diagnosed with drug-induced pulmonary arterial hypertension (PAH). Discontinuation of Qing-Dai rapidly improved PAH symptoms. The REVEAL 2.0 risk score, which is useful for assessing the severity of PAH and predicting prognosis, improved from high risk (12) to low risk (4) within 10 days. Discontinuing long-term use of Qing-Dai can rapidly improve Qing-Dai-induced PAH. Learning objective: Discontinuing the long-term use of Qing-Dai used for treating ulcerative colitis (UC) can rapidly improve Qing-Dai induced pulmonary arterial hypertension (PAH). REVEAL 2.0 risk score in patients who developed PAH due to Qing-Dai was useful for screening PAH in patients taking Qing-Dai for treatment of UC.

Impact of right coronary artery dominance on the long-term mortality in the patients with acute total/subtotal occlusion of unprotected left main coronary artery.

BACKGROUND: Patients with a right dominant coronary artery anatomy account for a significant proportion of acute myocardial infarction cases, and this condition is associated with a better prognosis. However, there are limited data on the impact of coronary dominance on patients with acute total/subtotal occlusion of unprotected left main coronary artery (ULMCA). METHODS: This study aimed to assess the impact of right coronary artery (RCA) dominance on long-term mortality in patients with acute total/subtotal occlusion of the ULMCA. From a multicenter registry, 132 cases of consecutive patients who had undergone emergent percutaneous coronary intervention (PCI) due to acute total/subtotal occlusion of the ULMCA were reviewed. RESULTS: Patients were classified into two groups according to the size of their RCA (dominant RCA group, n = 29; non-dominant RCA group, n = 103). Long-term outcomes were examined according to the presence of dominant RCA. Cardiopulmonary arrest (CPA) occurred in 52.3 % of patients before revascularization. All-cause death was significantly lower in the dominant RCA group than in the non-dominant RCA group. In the Cox regression model, dominant RCA was an independent predictor of all-cause death, as well as total occlusion of ULMCA, collateral from RCA, chronic kidney disease, and CPA. Patients were further analyzed according to the degree of stenosis of the ULMCA; patients with non-dominant RCA and total occlusive ULMCA had the worst outcome compared with the other groups. CONCLUSIONS: A dominant RCA might improve long-term mortality in patients with acute total/subtotal occlusion of the ULMCA who were treated with PCI.

Evaluating the one-time chair stand test for predicting the coronavirus disease severity in patients during hospital admission: a cohort study in Japan.

BACKGROUND: This study aimed to understand whether the one-time chair stand test (CS-1) is useful for predicting the severity of coronavirus disease (COVID-19) in 101 patients admitted to the hospital with acute respiratory failure. METHODS: This single-centered, prospective observational cohort study enrolled 101 critically ill adult patients hospitalized with COVID-19 who underwent the CS-1 as a dynamic evaluation tool in clinical practice between late April 2020 and October 2021. Data on demographic characteristics, symptoms, laboratory values, computed tomography findings, and clinical course after admission were collected. Furthermore, the data was compared, and the association between the intubation and non-intubation groups was determined. We also calculated the cutoff point, area under the curve (AUC), and 95% confidence interval (CI) of the change in oxygen saturation (ΔSpO2) during the CS-1. RESULTS: Thirty-three out of 101 patients (33%) were intubated during hospitalization. There was no significant difference in the resting SpO2 (93.3% versus 95.2%, P = 0.22), but there was a significant difference in ΔSpO2 during the CS-1 between the intubation and non-intubation groups (10.8% versus 5.5%, P < 0.01). In addition, there was a significant correlation between hospitalization and ΔSpO2 during the CS-1 (ρ = 0.60, P < 0.01). The generated cutoff point was calculated as 9.5% (AUC = 0.94, 95% CI = 0.88-1.00). CONCLUSION: For COVID-19 patients with acute respiratory failure, the CS-1 performed on admission was useful for predicting the severity of COVID-19. Furthermore, the CS-1 can be utilized as a remote and simple evaluation parameter. Thus, it could have potential clinical applications in the future.

Long-term outcomes of percutaneous revascularization for internal mammary artery-left anterior descending artery bypass failure.

Despite the excellent long-term results of internal mammary artery (IMA)-left anterior descending (LAD) bypass, percutaneous revascularization of IMA is sometimes required for IMA-LAD bypass failure. However, its clinical outcomes have not been fully elucidated. The aim of this study was to investigate the long-term clinical outcomes, including target lesion revascularization (TLR) following contemporary percutaneous revascularization of failed IMA bypass graft. We examined data of 59 patients who had undergone percutaneous revascularization of IMA due to IMA-LAD bypass failure at nine hospitals. Patients with IMA graft used for Y-composite graft or sequential bypass graft were excluded. The incidence of TLR was primarily examined, whereas other clinical outcomes including cardiac death, myocardial infarction, and target vessel revascularization were also evaluated. Mean age of the enrolled patients was 67.4 ± 11.3 years, and 74.6% were men. Forty patients (67.8%) had anastomotic lesions, and 17 (28.8%) underwent revascularization within three months after bypass surgery. Procedural success was achieved in 55 (93.2%) patients. Stent implantation was performed in 13 patients (22.0%). During a median follow-up of 1401 days (interquartile range, 282-2521 days), TLR was required in six patients (8.5% at 1, 3, and 5 years). Patients who underwent percutaneous revascularization within 3 months after surgery tended to have a higher incidence of TLR. Clinical outcomes of IMA revascularization for IMA-LAD bypass failure were acceptable.

Relationship between tissue characteristics and mechanical properties of coronary plaques: a comparison between integrated backscatter intravascular ultrasound (IVUS) and speckle-tracking IVUS.

High-risk coronary plaques have certain morphological characteristics. Thus, comprehensive assessment is needed for the risk stratification of plaques in patients with coronary artery disease. Integrated backscatter intravascular ultrasound (IB-IVUS) has been used successfully used to evaluate the tissue characteristics of coronary plaques; however, the mechanical properties of plaques have been rarely assessed. Therefore, we developed Speckle-tracking IVUS (ST-IVUS) to evaluate the mechanical properties of coronary plaque. This study aimed to evaluate the relation between the tissue characteristics of coronary plaques using IB-IVUS and their mechanical properties using ST-IVUS. We evaluated 95 non-targeted plaques in 95 patients undergoing elective percutaneous coronary intervention to the left anterior descending artery. We set regions of interest (ROIs) in the cross-sectional images of coronary plaques where we divided 120 degree plaques into four quadrants (every 30 degrees), with the center at the area of maximum atheroma thickness. We measured relative calcification area (%CA, relative fibrous area (%FI) and relative lipid pool area (%LP) in a total of 380 ROIs. In ST-IVUS analysis, we measured strain in the circumferential direction of the lumen area (LA strain: %), the external elastic membrane area strain (EEM strain: %), and strain in the radial direction (radial strain: %). On global cross-sectional area IB-IVUS analysis, the %CA was 1.2 ± 1.2%; the %FI was 49.0 ± 15.9%, and the %LP was 49.7 ± 16.5%. In ST-IVUS analysis, the LA strain was 0.67 ± 0.43%; the EEM strain was 0.49 ± 0.33%, and the radial strain was 2.02 ± 1.66%. On regional analysis, the %LP was not associated with the LA strain (r = - 0.002 p = 0.97), the EEM strain (r = - 0.05 p = 0.35), or with the radial strain (r = - 0.04 p = 0.45). These trends were seen between the %FI and the LA strain (r = 0.02 p = 0.74), the %FI and the EEM strain (r = 0.05 p = 0.35), and the %FI and the radial strain (r = 0.04 p = 0.50). A significant correlation was only observed between the %CA and the LA strain (r = - 0.15 p = 0.0038). Our findings indicate that the associations between mechanical properties and tissue characteristics lacked statistical significance, more often than not, and that it is necessary to evaluate the mechanical properties as well as plaque characteristics for risk stratification of coronary plaques.

Observation of plaque behavior and tissue characterization of coronary plaque using speckle tracking intravascular ultrasound (ST-IVUS) and iMap imaging system.

Tissue characterization plays an important role in the development of acute coronary syndromes. iMap is an intravascular ultrasound (IVUS) tissue characterization system that provides useful information by reconstructing color-coded maps. Mechanical properties due to dynamic mechanical stress during a cardiac cycle may also trigger vulnerable plaque. Speckle tracking IVUS (ST-IVUS) has been introduced to observe plaque behavior in relation to mechanical properties. We report the case of an 84-year-old woman with stable coronary artery disease who underwent percutaneous coronary intervention, at which time IVUS demonstrated mainly three low echoic areas like lipid pools with thick fibrous caps. Pathological evaluation with iMap revealed that one low echoic area was occupied with necrotic tissue and that the other two areas occupied fibrotic. Although those tissue characterizations were different, they showed similar stretching behavior at systole by ST-IVUS which depicted plaque behavior from IVUS images using a color mapping. The mechanical properties of individual coronary plaques may differ depending on the tissue disposition. It is necessary to consider mechanical properties using ST-IVUS as well as to evaluate tissue characterization in plaque risk stratification.

Level 3 tracheal injury in acute coronary syndrome treated conservatively with extracorporeal membrane oxygenation.

Level 3 tracheal injury, characterised by complete laceration with oesophageal or mediastinal soft-tissue herniation, is conventionally indicated for surgical repair. We present the case of a woman in her 60s with level 3 tracheal injury in acute coronary syndrome who was treated successfully without surgery. Venoarterial extracorporeal membrane oxygenation (ECMO) was introduced during lung-rest management to avoid positive pressure ventilation, and percutaneous coronary angioplasty was performed. Venoarterial ECMO was switched to venovenous ECMO when the haemodynamics improved. The tracheal injury healed spontaneously in 10 days, and ECMO was withdrawn on day 15. The patient made full recovery and was discharged on day 51.

Successful endoscopic clipping management of a left atrioesophageal fistula after atrial fibrillation catheter ablation: A case report of a young male patient.

Atrioesophageal fistula (AEF) is a rare and serious complication of atrial fibrillation (AF) ablation, forming a connection between the atrium and esophagus. A systematic treatment approach for AEF has not been established to date. Herein, we report the case of a young male patient with left AEF after AF catheter ablation, which was successfully treated with the Over-the-Scope Clip (Ovesco Endoscopy AG, Tübingen, Germany) and conservative management. Despite having a double-orifice mitral valve and tricuspid valve, the patient had no symptoms or valve disease. The patient was readmitted three weeks after the procedure owing to fever, hematemesis, consciousness disturbance, hemiplegia, and systemic convulsions. Indigenous bacteria in the oral cavity were detected in blood culture. Magnetic resonance imaging of the brain showed multiple cerebral infarctions. Chest computed tomography showed mediastinal air, suggesting an AEF diagnosis. Subsequently, an endoscopic closure using the Over-the-Scope Clip was performed, leading to a successful recovery and patient discharge on day 87 after admission. This is the first case report of a successful management of AEF after radiofrequency ablation using the Over-the-Scope Clip system. Although surgery is the main treatment for AEFs, we performed nonsurgical management using the clip, demonstrating a potential treatment option for AEF. Learning objective: Surgical intervention is usually superior to endoscopic intervention and conservative management for treatment of atrioesophageal fistula. To the best of our knowledge, this is the first case to be successfully managed by endoscopic clipping and conservative management.

Relative bradycardia in patients with moderate-to-severe COVID-19: a retrospective cohort study.

Coronavirus-related disease (COVID-19) can result in relative bradycardia; however, there are no reports on relative bradycardia in patients with moderate-to-severe COVID-19 who require oxygen. We retrospectively investigated 45 patients with moderate-to-severe COVID-19 and examined the relationship between heart rate and body temperature at the time of initiating oxygen or mechanical ventilation. For three consecutive days after initiating oxygen therapy, body temperature (day's highest temperature), heart rate, and other vital signs were measured simultaneously. We checked for relative bradycardia and analyzed the differences between patients with moderate COVID-19 (oxygen requirement ≤ 5 L/min) and those with severe COVID-19 (oxygen requirement ≥ 5 L/min). Of the 45 patients, 28 and 17 had moderate and severe COVID-19, respectively. The heart rate increased with increasing body temperature, and almost all patients satisfied the criteria of relative bradycardia. In Spearman's rank correlation analysis, body temperature was significantly correlated with heart rate (ρ = 0.483, p = 0.012) in moderately ill patients but not in severely ill patients (ρ = 0.261, p = 0.297). Multiple regression analysis revealed that the severity of COVID-19 and body temperature were independent predictors of heart rate. The predicted change in heart rate was 6.0 beats/min for each 1 °C rise in body temperature. Relative bradycardia was suggested to be a characteristic finding in patients with moderate-to-severe COVID-19 who require oxygen. Additionally, severely ill patients were more likely to develop relative bradycardia than moderately ill patients. Focusing on the relationship between heart rate and body temperature might help clinicians diagnose this disease in patients with worsening respiratory failure.

Impact of accelerated washout of Technetium-99m-sestamibi on exercise tolerance in patients with acute coronary syndrome: single-center experience.

Technetium-99m-sestamibi (99mTc-sestamibi) single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) in patients with acute coronary syndrome (ACS) could be used to assess area-at-risks, as well as myocardial infarct or saved sizes. In patients with ACS, accelerated washout of 99mTc-sestamibi during early and delayed imaging in the acute phase may suggest mitochondrial dysfunction in the injured but salvaged myocardium. However, the link between 99mTc-sestamibi accelerated washout and exercise tolerance is unknown. The purpose of this study was to investigate a possible association between 99mTc-sestamibi accelerated washout and exercise tolerance in acute ACS patients as they progressed into the chronic phase. One hundred and sixty-five patients with ACS who underwent 99mTc-sestamibi SPECT MPI during the acute phase were recruited. On this basis, we calculated the total perfusion deficits (TPDs) for early (1 h after tracer injection) and delayed (4 h after tracer injection) images using automated quantification software. We then subtracted the early TPDs from the delayed TPDs to calculate the ΔTPD. We conducted a cardiopulmonary exercise test in acute and chronic phases. We divided two groups according to the median ΔTPD (the ΔTPD ≥ 4 group and the ΔTPD < 4 group) and compared anaerobic threshold (AT; ml/kg/min) between the groups. For anaerobic threshold (AT) improvement in data analysis, we employed multivariate logistic regression analysis. A total of 101 ST-segment elevation myocardial infarctions, 36 non-ST-elevation myocardial infarctions, and 28 unstable angina pectoris events were reported as ACS. From acute phase (10.8 ± 4.2 ml/kg/min) to chronic phase (11.9 ± 2.3 ml/kg/min), the AT in the ΔTPD ≥ 4 group was significantly increased (p < 0.0001). This trend was also seen in the ΔTPD < 4 group from acute (11.4 ± 1.8 ml/kg/min) to chronic phase (12.1 ± 2.2 ml/kg/min, p = 0.015). AT was lower in the ΔTPD ≥ 4 group in the acute phase (p = 0.027), but there was no difference in AT between the two groups in the chronic phase (p = 0.60). ΔTPD and the absence of diabetes were both independent predictors of AT improvement in multivariate logistic regression analysis. Receiver-operating characteristic curve analysis determined that ΔTPD = 6 was the best cut-off value, with 60.0% sensitivity and 71.4% specificity, respectively. The accelerated washout of 99mTc-sestamibi in patients with ACS during the acute phase could help to predict improvement in exercise tolerance in the chronic phase.

＜Editors' Choice＞ Prevalence of acute coronary syndrome during the pandemic of COVID-19 in the Tokai Region of Japan.

The outbreak of coronavirus disease 19 (COVID-19) has had a great impact on medical care. During the COVID-19 pandemic, the rate of hospital admissions has been lower and the rate of in-hospital mortality has been higher in patients with acute coronary syndrome (ACS) in Western countries. However, in Japan, it is unknown whether the COVID-19 pandemic has affected the incidence of ACS. In the study, eleven hospitals in the Tokai region participated. Among enrolled hospital, we compared the incidence of ACS during the COVID-19 pandemic (April and May, 2020) with that in equivalent months in the preceding year as the control. During the study period; April and May 2020, 248 patients with ACS were admitted. Compared to April and May 2019, a decline of 8.1% [95% confidence interval (CI) 5.2-12.1; P = 0.33] in admissions for ACS was observed between April and May 2020. There was no significant difference in the strategy for revascularization and in-hospital deaths between 2019 and 2020. In conclusion, the rate of admission for ACS slightly decreased during the COVID-19 pandemic, compared to the same months in the preceding year. Moreover, degeneration of therapeutic procedures for ACS did not occur.

Clinical Outcomes Following Emergent Percutaneous Coronary Intervention for Acute Total/Subtotal Occlusion of the Left Main Coronary Artery.

BACKGROUND: Data regarding the clinical features, outcomes and prognostic factors in patients presenting with acute total/subtotal occlusion of the unprotected left main coronary artery (LMCA) remain limited.Methods and Results:From a multi-center registry, 134 patients due to acute total/subtotal occlusion of the unprotected LMCA were reviewed. Emergency room (ER) status classification was defined according to the presence of cardiogenic shock and cardiopulmonary arrest (CPA) in the ER (class 1=no cardiogenic shock; class 2= cardiogenic shock but not CPA; and class 3=CPA). In-hospital mortality and cerebral performance category (CPC) as the endpoints were evaluated. One-half (67/134) of the enrolled patients presented with total occlusion of the unprotected LMCA. Regarding ER status classification, class 1, 2, and 3 were observed in 30.6%, 45.5%, and 23.9% of the patients, respectively. In-hospital mortality occurred in 73 (54.5%) patients; of the remaining patients, 52 (85.3%) could be discharged with a CPC 1 or 2. ER status classification (odds ratio 4.4 [95% confidence interval: 2.33-10.67]; P<0.001) and total occlusion of the unprotected LMCA (odds ratio 8.29 [95% confidence interval 2.93-23.46]; P<0.001) were strong predictors of in-hospital mortality. CONCLUSIONS: Acute total/subtotal occlusion involving the unprotected LMCA appeared to be associated with high in-hospital mortality. ER status classification and initial flow in the unprotected LMCA were significant predictive factors of in-hospital mortality.

Assessment of visit-to-visit variability in systolic blood pressure over 5 years and phasic left atrial function by two-dimensional speckle-tracking echocardiography.

Visit-to-visit variability in systolic blood pressure (VVV-SBP) has been associated with increased cardiac events. Hence, volume analysis by two-dimensional speckle-tracking echocardiography (2-DSTE) allows physicians to easily measure phasic left atrial (LA) function. However, the relationship of VVV-SBP and functional deformation of the left atrium with patients' clinical outcome is unclear. The aim of the study was to investigate the relationship between phasic LA function and VVV-SBP. The subjects were 70 male participants in whom 2-DSTE was performed to measure blood pressure at health check-ups every year for 5 years. The standard deviation of systolic blood pressure (SBP) was calculated to assess VVV-SBP. The average SBP (Ave-SBP) was also assessed. Total emptying function (EF) (reservoir function), passive EF (conduit function), and active EF (booster pump function) of the left atrium were calculated to evaluate phasic LA function by 2-DSTE. The Pearson correlation, simple regression analysis, and multivariate logistic regression analysis were used in data analysis. Participants' mean age was 50 ± 10 years, and 16 participants had hypertension. VVV-SBP correlated with total EF (r = - 0.30, p = 0.014) and active EF (r = - 0.35, p = 0.003). There was no correlation between the standard deviation of SBP and passive EF (r = - 0.10, p = 0.39). Ave-SBP had no significant relationship with total EF (r = - 0.06, p = 0.62), passive EF (r = - 0.08, p = 0.50), or active EF (r = - 0.03, p = 0.78). Active EF was also associated with VVV-SBP in multiple regression analysis. The active EF was significantly decreased in the highest quartile of VVV-SBP. Despite the small sample size of our study, the VVV-SBP showed a relationship with the phasic LA function. Our findings suggest that high VVV-SBP is noted to be associated with cardiovascular risk including a deterioration of LA function in clinical practice.

Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial.

Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data have not been available. We conducted post hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95% CI 0.32-1.03, and non-HBR; 1.81% vs. 2.36%, HR 0.78, 95% CI 0.42-1.45; P for interaction = 0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95% CI 0.40-1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95% CI 0.43-1.84; P for interaction = 0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95% CI 0.03-0.65, and non-HBR; 0.40% vs. 0.85%, HR 0.48, 95% CI 0.14-1.58; P for interaction = 0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt-chromium stent-2 [STOPDAPT-2]; NCT02619760.

Safety and Efficacy of Human Muse Cell-Based Product for Acute Myocardial Infarction in a First-in-Human Trial.

BACKGROUND: Because ST-elevation myocardial infarction (STEMI) extensively damages the heart, regenerative therapy with pluripotent stem cells such as multilineage-differentiating stress enduring (Muse) cells is required.Methods and Results:In a first-in-human study, 3 STEMI patients with a left ventricular ejection fraction (LVEF) ≤45% after successful percutaneous coronary intervention received intravenously 1.5×107cells of a human Muse cell-based product, CL2020. The safety and efficacy on LVEF and wall motion score index (WMSI) were evaluated for 12 weeks. No adverse drug reaction was noted. LVEF and WMSI were markedly improved. CONCLUSIONS: The first-in-human intravenous administration of CL2020 was safe and markedly improved LV function in STEMI patients.

Relationships among pulmonary capillary wedge pressure, dry weight and natriuretic peptide in patients undergoing hemodialysis: a three-dimensional speckle tracking echocardiography study.

BACKGROUND: Although the evaluation of fluid status in hemodialysis (HD) patients is useful, relationship among pulmonary capillary wedge pressure (PCWP), dry body weight (DW) and natriuretic peptide has not been elucidated. In addition, there has been no objective marker for instantaneously monitoring hemodynamic improvement in response to HD. We previously reported that PCWP and time constant of left ventricular pressure decline (Tau) can be noninvasively estimated (ePCWP and eTau) by speckle tracking echocardiography (STE). The aim of this study was to elucidate the relationship among ePCWP, eTau, DW and natriuretic peptide in patients undergoing HD. METHODS: We measured ePCWP and body weight (BW) by STE in 81 patients and ANP and BNP by blood examination in 31 patients just before and after HD during sinus rhythm. RESULTS: The ePCWP decreased after HD, and this was associated with reductions in ln ANP, eTau and BW (r = 0.523, 0.271 and 0.814, respectively, p < 0.05). The % change in ePCWP was not correlated with the % change in ln BNP (p = 0.47). The change in ePCWP had a stronger correlation with the % change in BW than the change in any other parameters. CONCLUSIONS: The ePCWP is more sensitive to estimate the change in BW during HD than any other parameters such as ANP and BNP. These results indicated that a substantial amount of excess fluid can be assessed real-time by STE using ePCWP.