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This study aimed to complement the results of the REACH-2 study by prospectively evaluating the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma (HCC) in a real-world setting. This was an open-label, nonrandomized, multicenter, prospective study conducted at 13 institutions in Japan (jRCTs031190236). The study included Child-Pugh Class A patients with advanced HCC who had received pretreatment with atezolizumab plus bevacizumab (Atez/Bev) or lenvatinib. Ramucirumab was introduced as a second-line treatment after Atez/Bev or lenvatinib and as a third-line treatment after Atez/Bev and lenvatinib. Between May 2020 and July 2022, we enrolled 19 patients, including 17 who received ramucirumab. Additionally, seven patients received lenvatinib, another seven patients received Atez/Bev, and three patients received Atez/Bev followed by lenvatinib as prior treatment. The primary endpoint was a 6-month progression-free survival (PFS) rate, which was 14.3%. The median PFS and overall survival were 3.7 and 12.0 months, respectively. The most common grade ≥ 3 adverse events (AEs) were hypertension (23.5%), proteinuria (17.6%), and neutropenia (11.8%). The discontinuation rate due to AEs was 29.4%. Six patients progressed from Child-Pugh A to B after treatment with ramucirumab. Thirteen patients were eligible for post-ramucirumab treatment, including systemic therapy. Despite the limited number of patients, the efficacy of ramucirumab was comparable to that observed in the REACH-2 study when used after lenvatinib and Atez/Bev. However, the incidence of AEs was higher than that in the REACH-2 study.
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Anticuerpos Monoclonales Humanizados , Carcinoma Hepatocelular , Neoplasias Hepáticas , Ramucirumab , Humanos , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/patología , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/patología , Masculino , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Femenino , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Japón , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Quinolinas/uso terapéutico , Quinolinas/efectos adversos , Supervivencia sin Progresión , Anciano de 80 o más Años , Adulto , Compuestos de Fenilurea/uso terapéutico , Compuestos de Fenilurea/efectos adversos , Compuestos de Fenilurea/administración & dosificación , Antineoplásicos/uso terapéutico , Antineoplásicos/efectos adversos , Bevacizumab/uso terapéutico , Bevacizumab/efectos adversos , Bevacizumab/administración & dosificación , Pueblos del Este de AsiaRESUMEN
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. METHODSâANDâRESULTS: 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.
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Implantes Absorbibles , Vigilancia de Productos Comercializados , Humanos , Japón , Masculino , Femenino , Persona de Mediana Edad , Anciano , Intervención Coronaria Percutánea/efectos adversos , Tomografía de Coherencia Óptica , Estudios de Seguimiento , Andamios del Tejido , Isquemia Miocárdica , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
BACKGROUND: Despite an increased incidence of chronic heart failure (HF) and sudden cardiac death (SCD), the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) is much lower in Japan than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) prospectively assessed the mortality rate, appropriately treated ventricular arrhythmias (VA), and HF in Japanese patients with a higher risk of HF. METHODSâANDâRESULTS: HINODE consisted of ICD, CRT-defibrillator (CRT-D), pacing, and non-device treatment cohorts. This subanalysis evaluated the impact of the implantation of high-voltage devices (HVD; ICD and CRT-D) in 171 Japanese patients. We compared all-cause mortality, VA, and HF events between elderly (age >70 years at study enrollment) and non-elderly HVD recipients. The estimated survival rate through 24 months in the HVD cohort was 85.8% (97.5% lower control limit 77.6%). The risk of all-cause mortality was increased for the elderly vs. non-elderly (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.01-7.91; P=0.039), but did not differ after excluding ICD patients with CRT-D indication (HR 2.32; 95% CI 0.79-6.78; P=0.11). There were no differences in VA and HF event-free rates between elderly and non-elderly HVD recipients (P=0.73 and P=0.55, respectively). CONCLUSIONS: Although elderly patients may have a higher risk of mortality in general, the benefit of HVD therapy in this group is comparable to that in non-elderly patients.
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Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Humanos , Anciano , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/terapia , Masculino , Femenino , Japón/epidemiología , Anciano de 80 o más Años , Persona de Mediana Edad , Prevención Primaria , Estudios Prospectivos , Muerte Súbita Cardíaca/prevención & control , Factores de Edad , Factores de Riesgo , Pueblos del Este de AsiaRESUMEN
BACKGROUND: Direct oral anticoagulants (DOACs) are recommended as the first-choice anticoagulation therapy in the acute phase of venous thromboembolism (VTE). However, there is limited real-world data for Japanese VTE patients.MethodsâandâResults: The KUROSIO study (UMIN000023747) was a prospective long-term observational study comprising 1,017 patients with concurrent acute symptomatic pulmonary thromboembolism and proximal deep vein thrombosis (DVT) or isolated calf DVT initially treated with DOACs. After excluding 24 patients, 993 (mean age, 66.3±15.1 years; 58.6% females) were analyzed. The incidences of recurrent symptomatic VTE and major bleeding for up to 52 weeks after diagnosis were 3.2% and 2.2%, respectively. Multivariate analyses revealed chemotherapy and anemia as significant risk factors associated with recurrent symptomatic VTE and major bleeding, respectively. CONCLUSIONS: The efficacy and safety of DOACs in Japanese patients with VTE were determined in this real-world observational study.
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Cytokine release syndrome (CRS) is a systemic inflammatory syndrome that causes fatal circulatory failure due to hypercytokinemia, and subsequent immune cell hyperactivation caused by therapeutic agents, pathogens, cancers, and autoimmune diseases. In recent years, CRS has emerged as a rare, but significant, immune-related adverse event linked to immune checkpoint inhibitor therapy. Furthermore, several previous studies suggested that damage-associated molecular patterns (DAMPs) could be involved in malignancy-related CRS. In this study, we present a case of severe CRS following combination therapy with durvalumab and tremelimumab for advanced hepatocellular carcinoma, which recurred during treatment, as well as an analysis of cytokine and DAMPs trends. A 35-year-old woman diagnosed with hepatocellular carcinoma underwent a partial hepatectomy. Due to cancer recurrence, she started a combination of durvalumab and tremelimumab. Then, 29 days post-administration, she developed fever and headache, initially suspected as sepsis. Despite antibiotics, her condition worsened, leading to disseminated intravascular coagulation and hemophagocytic syndrome. The clinical course and elevated serum interleukin-6 levels led to a CRS diagnosis. Steroid pulse therapy was administered, resulting in temporary improvement. However, she relapsed with increased interleukin-6, prompting tocilizumab treatment. Her condition improved, and she was discharged on day 22. Measurements of inflammatory cytokines interferon-γ, tumor necrosis factor-α, and DAMPs, along with interleukin-6, using preserved serum samples, confirmed marked elevation at CRS onset. CRS can occur after the administration of any immune checkpoint inhibitor, with the most likely trigger being the release of DAMPs associated with tumor collapse.
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This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.
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Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Arteria Femoral/cirugía , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/etiología , Arteria Poplítea/cirugía , Arteria Poplítea/patología , Stents , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Estudios Multicéntricos como AsuntoRESUMEN
Platypnea-orthodoxia syndrome (POS) is a clinical condition that causes dyspnea and hypoxia in the sitting and standing positions. In this case, a 67-year-old man showed hypoxemia after undergoing the Bentall procedure that worsened in the standing position during rehabilitation. Contrast-enhanced computed tomography of the thorax and abdomen revealed no cause of respiratory failure. POS was suspected as the cause of the positional exacerbation of oxygen saturation. A bubble study showed a positive grade IV within three heartbeats on transthoracic echocardiography, which also confirmed an intracardiac shunt caused by a patent foramen ovale (PFO). Percutaneous PFO closure was performed, and hypoxemia was immediately resolved. Various factors were considered to cause the POS, including right heart failure, constrictive pericarditis, and postoperative adhesions, and each of these factors was discussed. POS after open-heart surgery is very rare. This is the first reported case of POS treated with a closure device following the Bentall procedure.
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Herein, we report a case of myocarditis in a 27-year-old male with long-term follow-up using longitudinal peak systolic strain (LPSS) measurements with transthoracic echocardiography (TTE) and late gadolinium enhancement (LGE) in cardiovascular magnetic resonance imaging (CMR). On admission, a predominant decrease was observed in the LPSS in the posterolateral segments of the TTE. After a period of two weeks, the values of the LPSS observed in the posterolateral segments were still slightly reduced, which is consistent with the LGE results in CMR. After a duration of 16â¯months, an improvement was noted in the LPSS and LGE results in all the segments. Moreover, a time-phase discrepancy was observed in the segmental longitudinal strain curve for a period of two weeks from the onset of myocarditis. However, an improvement in the discrepancy was detected after 16â¯months. Learning objective: Longitudinal peak systolic strain (LPSS) on transthoracic echocardiography (TTE) has predominantly focused on diagnosing the acute phase of myocarditis. Herein, LPSS was evaluated not only in the acute phase but also in the chronic phase. Furthermore, the relationship between the results of segmental LPSS and late gadolinium enhancement was documented. We would like to emphasize the usefulness of LPSS on TTE both for identifying myocarditis and as a tool for the long-term follow-up of patients.
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Real-world data on coronary events (CE) in elderly patients with atrial fibrillation (AF) are lacking in the direct oral anticoagulant era. This prespecified sub-analysis of the ANAFIE Registry, a prospective observational study in > 30,000 Japanese patients aged ≥ 75 years with non-valvular AF (NVAF), investigated CE incidence and risk factors. The incidence and risk factors for new-onset CE (a composite of myocardial infarction [MI] and cardiac intervention for coronary heart diseases other than MI), MI, and cardiac intervention for coronary heart diseases other than MI during the 2-year follow-up were assessed. Bleeding events in CE patients were also examined. Among 32,275 patients, the incidence rate per 100 patient-years was 0.48 (95% confidence interval (CI): 0.42-0.53) for CE during the 2-year follow-up, 0.20 (0.16-0.23) for MI, and 0.29 (0.25-0.33) for cardiac intervention for coronary heart diseases other than MI; that of stroke/systemic embolism was 1.62 (1.52-1.73). Patients with CE (n = 287) likely had lower creatinine clearance (CrCL) and higher CHADS2 and HAS-BLED scores than patients without CE (n = 31,988). Significant risk factors associated with new-onset CE were male sex, systolic blood pressure of ≥ 130 mmHg, diabetes mellitus (glycated hemoglobin ≥ 6.0%), CE history, antiplatelet agent use, and CrCL < 50 mL/min. Major bleeding incidence was significantly higher in patients with new-onset CE vs without CE (odds ratio [95% CI], 3.35 [2.06-5.43]). In elderly patients with NVAF, CE incidence was lower than stroke/systemic embolism incidence. New-onset CE (vs no CE) was associated with a higher incidence of major bleeding.Trial registration: UMIN000024006.
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Fibrilación Atrial , Enfermedad Coronaria , Embolia , Infarto del Miocardio , Accidente Cerebrovascular , Anciano , Humanos , Masculino , Femenino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Factores de Riesgo , Embolia/epidemiología , Embolia/etiología , Infarto del Miocardio/complicaciones , Sistema de Registros , Enfermedad Coronaria/complicaciones , Anticoagulantes/uso terapéuticoRESUMEN
BACKGROUND: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. OBJECTIVES: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
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Angioplastia de Balón , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Sirolimus , Dispositivos de Acceso Vascular , Grado de Desobstrucción Vascular , Humanos , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Anciano , Masculino , Femenino , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Estudios Prospectivos , Japón , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Factores de Tiempo , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano de 80 o más Años , Recurrencia , Resultado del Tratamiento , Diseño de Equipo , Factores de Riesgo , Persona de Mediana EdadRESUMEN
BACKGROUND: The Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial demonstrated non-inferior efficacy endpoints for rivaroxaban monotherapy versus combination therapy (rivaroxaban plus a single antiplatelet) and superior safety endpoints in patients with atrial fibrillation and stable coronary artery disease. AIMS: This post hoc analysis investigated whether the AFIRE trial results reflected the presence or absence of prior revascularisation. METHODS: Among 2,215 patients, 1,697 (76.6%) had previously undergone revascularisation, and the remaining 518 (23.4%) had not undergone prior revascularisation. The primary efficacy endpoint was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation, or death from any cause, while the primary safety endpoint was major bleeding. RESULTS: In 1,697 patients with prior revascularisation, the efficacy and safety endpoints were superior for monotherapy versus combination therapy (efficacy: hazard ratio [HR] 0.62, 95% confidence interval [CI]: 0.45-0.85; p=0.003; safety: HR 0.62, 95% CI: 0.39-0.98; p=0.042). Among 518 without prior revascularisation, there were no significant differences in endpoints (efficacy: HR 1.19, 95% CI: 0.67-2.12; p=0.554; safety: HR 0.47, 95% CI: 0.18-1.26; p=0.134). There was borderline interaction of the efficacy endpoints (p=0.055) between two treatments. The safety benefit of monotherapy on any bleeding was significant in patients without prior revascularisation (HR 0.59, 95% CI: 0.38-0.93; p=0.022). CONCLUSIONS: In high-risk thrombosis patients with a history of prior revascularisation, rivaroxaban monotherapy versus combination therapy demonstrated favourable safety and efficacy outcomes.
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Fibrilación Atrial , Enfermedad de la Arteria Coronaria , Accidente Cerebrovascular , Humanos , Anticoagulantes , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Fibrinolíticos/uso terapéutico , Hemorragia/inducido químicamente , Inhibidores de Agregación Plaquetaria , Rivaroxabán , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & controlRESUMEN
BACKGROUND: The TRUSTY study evaluated the efficacy of second-line trifluridine/tipiracil (FTD/TPI) plus bevacizumab in metastatic colorectal cancer (mCRC). OBJECTIVE: This exploratory biomarker analysis of TRUSTY investigated the relationship between baseline plasma concentrations of angiogenesis-related factors and cell-free DNA (cfDNA), and the efficacy of FTD/TPI plus bevacizumab in patients with mCRC. PATIENTS AND METHODS: The disease control rate (DCR) and progression-free survival (PFS) were compared between baseline plasma samples of patients with high and low plasma concentrations (based on the median value) of angiogenesis-related factors. Correlations between cfDNA concentrations and PFS were assessed. RESULTS: Baseline characteristics (n = 65) were as follows: male/female, 35/30; median age, 64 (range 25-84) years; and RAS status wild-type/mutant, 29/36. Patients in the hepatocyte growth factor (HGF)-low and interleukin (IL)-8-low groups had a significantly higher DCR (risk ratio [95% confidence intervals {CIs}]) than patients in the HGF-high (1.83 [1.12-2.98]) and IL-8-high (1.70 [1.02-2.82]) groups. PFS (hazard ratio {HR} [95% CI]) was significantly longer in patients in the HGF-low (0.33 [0.14-0.79]), IL-8-low (0.31 [0.14-0.70]), IL-6-low (0.19 [0.07-0.50]), osteopontin-low (0.39 [0.17-0.88]), thrombospondin-2-low (0.42 [0.18-0.98]), and tissue inhibitor of metalloproteinase-1-low (0.26 [0.10-0.67]) groups versus those having corresponding high plasma concentrations of these angiogenesis-related factors. No correlation was observed between cfDNA concentration and PFS. CONCLUSION: Low baseline plasma concentrations of HGF and IL-8 may predict better DCR and PFS in patients with mCRC receiving FTD/TPI plus bevacizumab, however further studies are warranted. CLINICAL TRIAL REGISTRATION NUMBER: jRCTs031180122.
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Ácidos Nucleicos Libres de Células , Neoplasias del Colon , Neoplasias Colorrectales , Demencia Frontotemporal , Pirrolidinas , Timina , Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Bevacizumab/farmacología , Bevacizumab/uso terapéutico , Neoplasias Colorrectales/patología , Interleucina-8/uso terapéutico , Uracilo/uso terapéutico , Trifluridina/farmacología , Trifluridina/uso terapéutico , Angiogénesis , Demencia Frontotemporal/tratamiento farmacológico , Inhibidor Tisular de Metaloproteinasa-1/uso terapéutico , Neoplasias del Colon/tratamiento farmacológico , Ácidos Nucleicos Libres de Células/uso terapéutico , Biomarcadores , Protocolos de Quimioterapia Combinada Antineoplásica/farmacología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéuticoRESUMEN
BACKGROUND: During systemic therapy, the management of portal hypertension (PH)-related complications is vital. This study aimed to clarify factors associated with the incidence and exacerbation of PH-related complications, including the usefulness of contrast-enhanced computed tomography (CECT) in the management of PH-related complications during systemic therapy. METHODS: A total of 669 patients who received systemic therapy as first-line treatment (443 patients for sorafenib, 131 for lenvatinib, and 90 for atezolizumab/bevacizumab [ATZ/BEV]) were enrolled in this retrospective study. Additionally, the lower esophageal intramural vessel diameters (EIV) on CECT and endoscopic findings in 358 patients were compared. RESULTS: The cutoff values of the EIV diameter on CECT were 3.1 mm for small, 5.1 mm for medium, and 7.6 mm for large varices, demonstrating high concordance with the endoscopic findings. esophageal varices (EV) bleeding predictors include EIV ≥ 3.1 mm and portal vein tumor thrombosis (PVTT). In patients without EV before systemic therapy, factors associated with EV exacerbation after 3 months were EIV ≥ 1.9 mm and ATZ/BEV use. Predictors of hepatic encephalopathy (HE) include the ammonia level or portosystemic shunt diameter ≥ 6.8 mm. The incidence of HE within 2 weeks was significantly higher (18%) in patients with an ammonia level ≥ 73 µmol/L and a portosystemic shunt ≥ 6.8 mm. The exacerbating factors for ascites after 3 months were PVTT and low albumin levels. CONCLUSIONS: Careful management is warranted for patients with risk factors for exacerbation of PH-related complications; moreover, the effective use of CECT is clinically important.
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Bevacizumab , Carcinoma Hepatocelular , Várices Esofágicas y Gástricas , Hipertensión Portal , Neoplasias Hepáticas , Compuestos de Fenilurea , Sorafenib , Humanos , Hipertensión Portal/etiología , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Factores de Riesgo , Várices Esofágicas y Gástricas/etiología , Várices Esofágicas y Gástricas/epidemiología , Compuestos de Fenilurea/efectos adversos , Compuestos de Fenilurea/administración & dosificación , Compuestos de Fenilurea/uso terapéutico , Sorafenib/efectos adversos , Sorafenib/uso terapéutico , Sorafenib/administración & dosificación , Bevacizumab/administración & dosificación , Bevacizumab/efectos adversos , Bevacizumab/uso terapéutico , Tomografía Computarizada por Rayos X , Quinolinas/uso terapéutico , Quinolinas/efectos adversos , Quinolinas/administración & dosificación , Encefalopatía Hepática/etiología , Encefalopatía Hepática/epidemiología , Antineoplásicos/efectos adversos , Antineoplásicos/administración & dosificación , Adulto , Anciano de 80 o más Años , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/epidemiología , IncidenciaRESUMEN
PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.
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Angioplastia de Balón , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Grado de Desobstrucción Vascular , Humanos , Masculino , Arteria Poplítea/diagnóstico por imagen , Femenino , Anciano , Arteria Femoral/diagnóstico por imagen , Estudios Prospectivos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Angioplastia de Balón/métodos , Anciano de 80 o más Años , Resultado del Tratamiento , JapónRESUMEN
BACKGROUND: The geographical disparity in the pathophysiological pattern of coronary artery disease (CAD) among patients undergoing percutaneous coronary intervention (PCI) is unknown. OBJECTIVES: To elucidate the geographical variance in the pathophysiological characteristics of CAD. METHODS: Physiological indices derived from angiography-based fractional flow reserve pullbacks from patients with chronic coronary syndrome enrolled in the ASET Japan (n = 206) and ASET Brazil (n = 201) studies, which shared the same eligibility criteria, were analysed. The pathophysiological patterns of CAD were characterised using Murray law-based quantitative flow ratio (µQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the µQFR pullback pressure gradient index. RESULTS: Significant functional stenoses pre-PCI (µQFR ≤0.80) were more frequent in ASET Japan compared to ASET Brazil (89.9% vs. 67.5%, p < 0.001), as were rates of a post-PCI µQFR <0.91 (22.1% vs. 12.9%, p = 0.013). In the multivariable analysis, pre-procedural µQFR and diffuse disease were independent factors for predicting a post-PCI µQFR <0.91, which contributed to the different rates of post-PCI µQFR ≥0.91 between the studies. Among vessels with a post-PCI µQFR <0.91, a consistent diffuse pattern of CAD pre- and post-PCI occurred in 78.3% and 76.7% of patients in ASET Japan and Brazil, respectively; only 6.3% (Japan) and 10.0% (Brazil) of vessels had a major residual gradient. Independent risk factors for diffuse disease were diabetes mellitus in ASET Japan, and age and male gender in Brazil. CONCLUSIONS: There was geographic disparity in pre-procedural angiography-based pathophysiological characteristics. The combined pre-procedural physiological assessment of vessel µQFR and diffuseness of CAD may potentially identify patients who will benefit most from PCI.
Asunto(s)
Enfermedad de la Arteria Coronaria , Reserva del Flujo Fraccional Miocárdico , Intervención Coronaria Percutánea , Humanos , Masculino , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/epidemiología , Intervención Coronaria Percutánea/efectos adversos , Reserva del Flujo Fraccional Miocárdico/fisiología , Angiografía Coronaria , Resultado del Tratamiento , Vasos Coronarios , Valor Predictivo de las PruebasRESUMEN
Introducción y objetivos En estudios previos se ha descrito que la intervención coronaria aplicada a lesiones complejas presenta una correlación independiente con las hemorragias mayores. La puntuación SYNTAX es un instrumento angiográfico utilizado para evaluar el grado de complejidad de las enfermedades arteriales coronarias. El objetivo de este estudio es evaluar la capacidad de la puntuación SYNTAX para predecir hemorragias mayores tras el implante de stents liberadores de fármacos. Métodos Se analizó a un total de 722 pacientes sometidos a implante de stents liberadores de fármacos de una población de pacientes consecutivos incluidos en el estudio entre enero de 2007 y abril de 2010. Se investigó la incidencia de hemorragias mayores y trombosis delstent durante un periodo de 2 años. La hemorragia mayor se evaluó mediante la puntuación CRUSADE y los criterios del Bleeding Academic Research Consortium. Se estratificó a los pacientes en los siguientes grupos según los criterios del ensayo SYNTAX: baja (≤ 22; n = 484), intermedia (23-32; n = 128) y alta (≥ 33; n=110). Resultados: Se observaron hemorragias mayores en 47 pacientes (6,5%) en el periodo de estudio de 2 años, y hubo 12 episodios de trombosis del stent (1,7%). Las tasas de hemorragia mayor en los pacientes de los terciles bajo, intermedio y alto de la puntuación SYNTAX fueron del 2,9, el 7,8 y el 20,9% respectivamente (p<0,0001). La puntuación SYNTAX mostró una hazard ratio ajustada de hemorragia mayor a los 2 años de 1,81 (intervalo de confianza del 95%, 1,27-2,57). El valor predictivo del área bajo la curva de características operativas del receptor ajustada por hemorragia mayor mejoró significativamente tras la inclusión de la puntuación CRUSADE (estadístico C, 0,890 frente a 0,812). Conclusiones: Aunque la puntuación SYNTAX puede predecir el riesgo de hemorragias mayores, el valor predictivo de la puntuación CRUSADE fue superior. Estas puntuaciones pueden resultar de utilidad en la toma de decisiones clínicas respecto a las estrategias de revascularización y la duración óptima del tratamiento antiagregante plaquetario doble tras implante de stents liberadores de fármacos
Introduction and objectives Previous studies have eported that coronary intervention for complex lesions is independently correlated with major bleeding. The SYNTAX score is an angiographic tool used to grade the complexity of coronary artery diseases. The aim of this study was to assess the ability of the SYNTAX score to predict major bleeding following drug-eluting stent implantation. Methods We analyzed 722 patients who underwent drug-eluting stent implantation in an all-comers population between January 2007 and April 2010. The incidence of major bleeding and stent thrombosis was investigated during a 2-year period. Major bleeding was evaluated using the CRUSADE score and Bleeding Academic Research Consortium criteria. Patients were stratified into the following groups according to the SYNTAX trial: low (≤ 22; n = 484), intermediate (2332; n = 128), and high (≥ 33; n = 110).Results Major bleeding was observed in 47 patients (6.5%) during the 2-year period, and there were 12 incidents of stent thrombosis (1.7%). Major bleeding rates for patients in the low, intermediate, and high SYNTAX score tertiles were 2.9%, 7.8%, and 20.9%, respectively (P < .0001). The SYNTAX score had an adjusted hazard ratio of 1.81 (95% confidence interval, 1.27-2.57) for 2-year major bleeding. The predictive value of the adjusted area under the receiver operating characteristic curve for major bleeding significantly improved after inclusion of the CRUSADE score (C statistic, 0.890 vs 0.812). Conclusions: Although the SYNTAX score can predict major bleeding risk, the predictive value of the CRUSADE score was higher. These scores may be useful in clinical decision-making on revascularization strategies and on the optimal duration of dual antiplatelet therapy following drug-eluting stent implantation