Biolimus-eluting versus everolimus-eluting stents in coronary artery disease: A pooled analysis from the NEXT (NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent) and COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimuseluting stent) randomised trials
Vlachojannis G.J.,Maasstad Hospital |
Puricel S.,University of Fribourg |
Natsuaki M.,Saiseikai Fukuoka General Hospital |
Morimoto T.,Hyogo College of Medicine |
And 2 more authors.
EuroIntervention | Year: 2017
Aims: This study sought to investigate the safety and efficacy of a biolimus-eluting stent with biodegradable polymer (BP-BES) (Nobori; Terumo Corp.) compared to an everolimus-eluting stent with durable polymer (DP-EES) (XIENCE V or Prime; Abbott Vascular, or PROMUS; Boston Scientific). Methods and results: The all-comers NEXT and COMPARE II clinical trials randomly assigned 5,942 patients to BP-BES (N=3,412) or DP-EES (N=2,530). We conducted a patient level pooled analysis at three-year follow-up with specified study endpoints: definite stent thrombosis (ST), the combined safety endpoint cardiac death or target vessel myocardial infarction (TV-MI), and the efficacy endpoint target lesion revascularisation (TLR). At three-year follow-up, all endpoints, namely definite stent thrombosis (BP-BES 0.8% vs. 0.4%, p=0.20), death or TV-MI (BP-BES 7.8% vs. 6.7%, p=0.07), as well as TLR (BP-BES 6.4% vs. 6.4%, p=0.78) were similar between groups. Interestingly, unadjusted (BP-BES 5.6% vs. 4.5%, p=0.02) and adjusted (HR 1.36; 1.01-1.82, p=0.04) TV-MI rates were higher in the BP-BES group than in the DP-EES group. Conclusions: In this large-scale patient level pooled analysis of the NEXT and COMPARE II randomised trials, the use of BP-BES compared with DP-EES resulted in similar outcomes, but with an observed higher rate of TV-MI in the BP-BES group. © Europa Digital & Publishing 2017. All rights reserved.
Hironaka S.,Chiba Cancer Center |
Sugimoto N.,Japan National Cardiovascular Center Research Institute |
Yamaguchi K.,Saitama Cancer Center |
Moriwaki T.,University of Tsukuba |
And 15 more authors.
The Lancet Oncology | Year: 2016
Background: Although leucovorin enhances the efficacy of fluorouracil, the anti-tumour activity of S-1 and leucovorin and their combination with oxaliplatin for patients with advanced gastric cancer is unknown. We compared the activity and safety of S-1 plus leucovorin, S-1 plus leucovorin and oxaliplatin, and S-1 plus cisplatin as first-line chemotherapy for advanced gastric cancer. Methods: In this multicentre, randomised, open-label, phase 2 trial, we recruited chemotherapy-naive patients with unresectable or recurrent gastric cancer with measurable lesions aged 20 years or older from 25 general hospitals and specialist centres in Japan. Patients were randomly assigned (1:1:1) centrally to receive S-1 plus leucovorin (S-1 40-60 mg orally plus oral leucovorin 25 mg twice a day for 1 week, every 2 weeks), S-1 plus leucovorin and oxaliplatin (S-1 plus leucovorin and intravenous oxaliplatin 85 mg/m2 on day 1, every 2 weeks), or S-1 plus cisplatin (S-1 40-60 mg orally twice a day for 3 weeks, plus intravenous cisplatin 60 mg/m2 on day 8, every 5 weeks). Randomisation was done with the minimisation method using performance status (0 vs 1) and tumour stage (stage IV vs recurrent) as stratification factors. The primary endpoint was independently reviewed overall response in the full analysis set. This trial is registered with Japic CTI, number 111635. Findings: Between Oct 20, 2011, and Dec 17, 2012, we enrolled and randomly assigned 145 patients: 49 patients were assigned to S-1 plus leucovorin, 47 to S-1 plus leucovorin and oxaliplatin, and 49 to S-1 plus cisplatin. An objective response assessed by the independent review committee was achieved in 20 (43% [95% CI 28·3-57·8]) of the 47 patients in the S-1 plus leucovorin group, 31 (66% [50·7-79·1]) of the 47 patients in the S-1 plus leucovorin and oxaliplatin group, and 22 (46% [31·4-60·8]) of the 48 patients in the S-1 plus cisplatin group (Fisher's exact test, p=0·84 for S-1 plus leucovorin vs S-1 plus cisplatin, p=0·063 for S-1 plus leucovorin and oxaliplatin vs S-1 plus cisplatin, and p=0·038 for S-1 plus leucovorin and oxaliplatin vs S-1 plus leucovorin). The most common grade 3-4 adverse events were neutropenia (three [6%] of 48 patients in the S-1 plus leucovorin group vs 12 [26%] of 47 patients in the S-1 plus leucovorin and oxaliplatin group vs 17 [35%] of 49 patients in the S-1 plus cisplatin group), decreased appetite (six [13%] vs 14 [30%] vs 12 [24%]), anaemia (five [10%] vs seven [15%] vs 13 [27%]), and hyponatraemia (two [4%] vs two [4%] vs nine [18%]). Interpretation: S-1 plus leucovorin and oxaliplatin was more active than S-1 plus leucovorin or S-1 plus cisplatin with acceptable toxic effects for patients with advanced gastric cancer. A phase 3 trial comparing S-1 plus leucovorin and oxaliplatin with S-1 plus cisplatin is underway. Funding: Taiho Pharmaceutical. © 2016 Elsevier Ltd.
Sakamoto A.,Saiseikai Fukuoka General Hospital |
Kiyokawa K.,Kurume University |
Rikimaru H.,Kurume University |
Watanabe K.,Kurume University |
Nishi Y.,Kurume University
Journal of Plastic, Reconstructive and Aesthetic Surgery | Year: 2012
When performing auriculoplasty for microtia surgery, wires are typically used to fix the costal cartilage frames. However, cases in which such wires become exposed during a long-term follow-up were frequently observed at our facility. Hence, using various materials, we conducted an investigation of the materials most suitable for fixation. Method: The subjects consisted of 122 cases in which auriculoplasty by costal cartilage graft surgery was performed and the postoperative course was traceable, within approximately 24 years from January 1984 to March 2007. Regarding the fixation materials used in the 84 cases in which wire was used, 5 cases used monofilament non-absorbable sutures (Nylon ®), 5 cases used monofilament absorbable sutures (PDS ®), and 28 cases used braided absorbable sutures(VICRYL ®).Their postoperative course was investigated, and the presence of auricular deformities caused by a loosening of the fixation materials and the exposure of the fixation materials was examined. Results: An exposure of the wire was observed in 19 cases (22.6%) of the 84 cases that used wires. An exposure of nylon was observed in 2 (40%) of 5 the cases that used nylon, and of those, a mild deformation was observed in the lower helix in one case that was suspected to have been caused by a loosening of the surgical suture. Regarding the 33 cases in which absorbable sutures were used (5 cases used monofilament absorbable sutures and 28 cases used braided absorbable sutures), neither any auricular deformities nor exposure of the fixation materials was observed in any of the cases. Conclusion: Whether using monofilament or braided sutures, absorbable sutures are therefore believed to be the most suitable material for the fixation of cartilage. © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Soejima Y.,Kyushu University |
Soejima Y.,Saiseikai Fukuoka General Hospital |
Shirabe K.,Kyushu University |
Taketomi A.,Kyushu University |
And 7 more authors.
American Journal of Transplantation | Year: 2012
Adult left lobe (LL) living donor liver transplantation (LDLT) has not generally been recognized as a feasible procedure because of the problem of graft size. The objectives of this study were to assess the feasibility and short- and long-term results of adult LL LDLT in comparison with right lobe (RL) LDLT. Data on 200 consecutive LL LDLTs, including five retransplants, were retrospectively compared with those of 112 RL LDLTs, in terms of survival, complications and donor morbidity. The mean graft weight to standard volume ratio of LL grafts was 38.7% whereas that of RL grafts was 47.6% (p < 0.0001). The 1-, 5- and 10-year patient survival rates of LL LDLT were 85.6%, 77.9% and 69.5%, respectively, which were comparable to those of RL LDLT (89.8%, 71.3% and 70.7%, respectively). The incidence of small-for-size syndromewas higher in LL LDLT (19.5%) than in RL LDLT (7.1%) (p < 0.01). The overall donor morbidity rates were comparable between LL (36.0%) and RL (34.8%), whereas postoperative liver function tests and hospital stay were significantly better (p < 0.0001) in LL donors. In conclusion, adult LL LDLT has comparable outcomes to that of RL LDLT. LL LDLT is viable and is the first choice in adult LDLT. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.
Natsuaki M.,Saiseikai Fukuoka General Hospital |
Morimoto T.,Hyogo College of Medicine |
Furukawa Y.,Kobe City Medical Center General Hospital |
Shiomi H.,Kyoto University |
And 2 more authors.
Atherosclerosis | Year: 2014
Objective: Effects of statin therapy on cardiovascular outcomes in super-elder population ≥80 years of age have been poorly understood, despite its established role in non-super-elder population. Methods: Among 14,834 patients undergoing first coronary revascularization in the CREDO-Kyoto Registry Cohort-2, patients were divided into 2 strata based on age and patients in each stratum were further divided into 2 groups based on statin therapy at discharge; ≥80 years of age: 2017 patients (statin group: N=765, no-statin group: N=1252) and <80 years of age: 12,817 patients (statin group: N=6523, no-statin group: N=6294). Results: Through 5-year follow-up, cumulative incidences of major adverse cardiovascular events (MACE: composite of cardiovascular death, myocardial infarction and stoke) were significantly lower in the statin group than in the no-statin group in both strata (23.4% versus 32.0%, P=0.0003 in patients ≥80 years of age and 11.5% versus 16.1%, P<0.0001 in patients <80 years of age). After adjusting confounders, statin therapy was associated with significantly reduced risk for MACE not only in patients <80 years of age (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.74-0.91, P<0.0001), but also in patients ≥80 years of age (HR 0.77, 95% CI 0.64-0.93, P=0.006). There was no interaction between age and the effect of statins (. P interaction=0.86). Conclusions: Statin therapy at discharge from first coronary revascularization was associated with significantly reduced risk for cardiovascular events even in patients ≥80 years of age. There was no difference in the direction and magnitude of treatment effect of statins between the super-elder and non-super-elder patients. © 2014 Elsevier Ireland Ltd.
Kayashima H.,Saiseikai Fukuoka General Hospital
Asian journal of endoscopic surgery | Year: 2011
We report on a case of a female patient diagnosed with inflammatory pseudotumor of the liver in association with spilled gallstones 3 years after laparoscopic cholecystectomy for calculous acute cholecystitis. She was asymptomatic, but CT revealed an intrahepatic mass and two other extrahepatic masses between the liver and the diaphragm. Furthermore, diffusion-weighted MRI and PET suggested all three lesions could be malignant tumors. As the preoperative diagnosis was intrahepatic cholangiocellular carcinoma with peritoneal disseminations, we performed a posterior segmentectomy of the liver combined with partial resection of the diaphragm. Histological examination showed the intrahepatic tumor was an inflammatory granuloma with abscess formations. There were bilirubin stones between the liver and the diaphragm. Therefore, the tumor was diagnosed as inflammatory pseudotumor of the liver in association with spilled gallstones. In conclusion, the liver tumor emerged after laparoscopic cholecystectomy and may involve inflammatory pseudotumor of the liver in association with spilled gallstones. © 2011 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Blackwell Publishing Asia Pty Ltd.
Nozoe M.,Saiseikai Fukuoka General Hospital |
Sakamoto T.,Saiseikai Kumamoto Hospital Cardiovascular Center |
Taguchi E.,Saiseikai Kumamoto Hospital Cardiovascular Center |
Miyamoto S.,Saiseikai Kumamoto Hospital Cardiovascular Center |
And 2 more authors.
Journal of Cardiology | Year: 2014
Objective: Before reperfusion therapy was introduced, the incidence of ventricular septal and left ventricular free wall rupture complicating acute myocardial infarction (AMI) was 1-3%. Primary percutaneous coronary intervention (PCI) was expected to reduce the incidence of such mechanical complications. Methods: We retrospectively analysed 1290 AMI patients referred to our institute from January 2005 to January 2011. Primary PCI was done in 1002 cases of the study patients (77.7%). Results: Ventricular septal rupture (VSR) occurred in 19 cases (1.5%) and left ventricular free wall rupture (LVFR) in 17 cases (1.3%). Mean observation periods from onset to VSR and LVFR were 2.6 days. We demonstrated that risk factors for LV rupture were advanced age, female sex, absence of history of angina or myocardial infarction, lack of previous PCI, and absence of previous hypertension. Coronary angiography revealed that the culprit lesions of the left anterior descending artery or single vessel disease were the risk factors for LV rupture. Furthermore, in the present observation, 9 patients (47.4%) with VSR and 8 patients (47.1%) with LVFR developed LV rupture within 24. h after symptoms onset (early rupture). The early rupture demonstrated extremely poor outcome compared with late rupture (in-hospital mortality was 88.2% in early rupture and 63.1% in late rupture). Conclusion: Even in the patients' cohort with higher prevalence of primary PCI, LV rupture cases were not decreased in contrast to our expectations. More attention should be paid to early LV rupture cases within 24. h from symptom onset in those cases. © 2013 Japanese College of Cardiology.
Ono T.,Saiseikai Fukuoka General Hospital |
Sanai T.,Fukumitsu Hospital |
Miyahara Y.,Saiseikai Fukuoka General Hospital |
Noda R.,Saiseikai Fukuoka General Hospital
Current Therapeutic Research - Clinical and Experimental | Year: 2013
Background: Angiotensin II receptor antagonists (ARBs) have a protective effect in patients with chronic kidney disease (CKD) by suppressing progression, possibly by controlling hypertension. One marker of progression in such patients is the degree of proteinuria. Objective: We aimed to retrospectively examine the protective effect of ARBs (olmesartan, losartan, candesartan, and valsartan) on CKD patients without a history of diabetic nephropathy. Methods: Data were retrieved from medical records of patients with a diagnosis of CKD (serum creatinine [Cre] <3.0 mg/dL [265.2 μmol/L] and urinary protein of 0.3-3.5 g/g Cre) who were treated with ARBs and those with diabetic nephropathy were excluded. Blood pressure, serum Cre, urinary protein, urinary Cre, and estimated glomerular filtration rate were measured before the research began and at 1, 3, 6, 12, and 24 months after the ARB treatment was started. Results: Forty-four patients completed the research protocol. Of these, 10 took olmesartan, 13 took losartan, 9 took candesartan, 9 took valsartan, and 3 took telmisartan. Systolic blood pressure was decreased in all cases. The extent of this decrease 1 month after starting ARB treatment was greater for olmesartan than for candesartan ( P < 0.05), and after 2 years, it was greater than for losartan ( P < 0.05). Diastolic blood pressure decreased in all patients; this decrease was significantly greater with olmesartan 1 month after treatment started than with candesartan ( P < 0.05). Olmesartan significantly decreased daily urinary protein compared with that with the other ARBs during follow-up. This decrease 1 month after starting ARB treatment was greater for olmesartan than losartan, valsartan, and candesartan ( P < 0.01, P < 0.01, and P < 0.05, respectively), and after 2 years, this effect was still significant ( P < 0.05, P < 0.01, and P < 0.01, respectively). Conclusions: Olmesartan is more effective in reducing urinary protein than other ARBs, suggesting that the renal protective effects of olmesartan may be better than those of other ARBs. © 2013 The Authors.
Sakamoto K.,Saiseikai Fukuoka General Hospital |
Yamamoto Y.,Saiseikai Fukuoka General Hospital |
Okamatsu H.,Saiseikai Fukuoka General Hospital |
Okabe M.,Saiseikai Fukuoka General Hospital
Hellenic Journal of Cardiology | Year: 2011
Introduction: Acute aortic dissection (AAD), acute pulmonary embolism (PE) and acute myocardial infarction (AMI) are all emergent diseases with acute chest pain. However, it is sometimes difficult to diagnose these diseases by symptoms, ECG changes and/or cardiac biomarkers, especially immediately after onset. Because these diseases are all thrombogenic diseases, we considered that D-dimer could be helpful to differentiate these diseases. The purpose of this research was to define the D-dimer value for discrimination between AAD, PE and AMI. Methods: Plasma D-dimer values of a consecutive series of 35 AAD, 22 PE and 206 AMI patients on admission were analyzed retrospectively. Results: The D-dimer values of patients with AAD (32.9 ± 66.7 μg/ml, p<0.001) and PE (28.5 ± 23.6 μg/ ml, p<0.001) were significantly higher than those of AMI patients (2.1 ± 3.7 μg/ml). A cutoff value of 5.0 μg/ ml was effective in distinguishing AAD and PE from AMI, with a sensitivity of 68% and a specificity of 90%. Conclusions: Our study showed the possibility that D-dimer could enable faster diagnosis and treatment of AAD, PE and AMI patients. We expect that the D-dimer test will be used more often for screening patients with possible AAD, PE or AMI in the emergency room. We would recommend contrast computed tomography first, not coronary angiography, in a patient with a D-dimer level higher than 5.0 μg/ml using our diagnostic kit.
PubMed | Saga Heavy Ion Medical Accelerator in Tosu, Kyushu University and Saiseikai Fukuoka General Hospital
Type: Journal Article | Journal: Medical physics | Year: 2017
In radiation treatment planning, delineation of gross tumor volume (GTV) is very important, because the GTVs affect the accuracies of radiation therapy procedure. To assist radiation oncologists in the delineation of GTV regions while treatment planning for lung cancer, we have proposed a machine-learning-based delineation framework of GTV regions of solid and ground glass opacity (GGO) lung tumors following by optimum contour selection (OCS) method.Our basic idea was to feed voxel-based image features around GTV contours determined by radiation oncologists into a machine learning classifier in the training step, after which the classifier produced the degree of GTV for each voxel in the testing step. Ten data sets of planning CT and PET/CT images were selected for this study. The support vector machine (SVM), which learned voxel-based features which include voxel value and magnitudes of image gradient vector that obtained from each voxel in the planning CT and PET/CT images, extracted initial GTV regions. The final GTV regions were determined using the OCS method that was able to select a global optimum object contour based on multiple active delineations with a level set method around the GTV. To evaluate the results of proposed framework for ten cases (solid:6, GGO:4), we used the three-dimensional Dice similarity coefficient (DSC), which denoted the degree of region similarity between the GTVs delineated by radiation oncologists and the proposed framework.The proposed method achieved an average three-dimensional DSC of 0.81 for ten lung cancer patients, while a standardized uptake value-based method segmented GTV regions with the DSC of 0.43. The average DSCs for solid and GGO were 0.84 and 0.76, respectively, obtained by the proposed framework.The proposed framework with the support vector machine may be useful for assisting radiation oncologists in delineating solid and GGO lung tumors.