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Article ; Online: Managing hypertriglyceridemia for cardiovascular disease prevention: Lessons from the PROMINENT trial.

Yamashita, Shizuya / Hirano, Tsutomu / Shimano, Hitoshi / Tsukamoto, Kazuhisa / Yoshida, Masayuki / Yoshida, Hiroshi

European journal of clinical investigation

2024 , Page(s) e14227

Abstract: Background: Numerous epidemiological studies have shown that hypertriglyceridemia is a significant risk factor for cardiovascular diseases (CVD). However, large clinical studies on triglyceride-lowering therapy have yielded inconsistent results. In the ... ...

Abstract	Background: Numerous epidemiological studies have shown that hypertriglyceridemia is a significant risk factor for cardiovascular diseases (CVD). However, large clinical studies on triglyceride-lowering therapy have yielded inconsistent results. In the current review, we reassess the importance of triglyceride-lowering therapy in preventing CVD based on previous literature and the recently published findings of the PROMINENT trial. Methods: This narrative review is based on literature and public documents published up to November 2023. Results: Meta-analyses of trials on peroxisome proliferator-activated receptor α agonists and triglyceride-lowering therapy, including the PROMINENT trial, have indicated that triglyceride-lowering therapy can reduce CVD events. Mendelian randomization studies have also indicated that triglyceride is indeed a true risk factor for coronary artery disease, leaving no doubt about its relationship to CVD. Meanwhile, the negative results from the PROMINENT trial were likely due to the insufficient triglyceride-lowering effect, slight increases in low-density lipoprotein cholesterol and apolipoprotein B, and the inclusion of mostly high-intensity statin users as target patients. It is unlikely that adverse events counteracted the effectiveness of pemafibrate on outcomes. Additionally, pemafibrate has shown positive effects on non-alcoholic fatty liver disease and peripheral artery disease. Conclusion: Although the PROMINENT trial did not demonstrate the significance of pemafibrate as a triglyceride-lowering therapy in a specific population, it does not necessarily negate the potential benefits of treating hypertriglyceridemia in reducing CVD events. It is necessary to explore appropriate populations that could benefit from this therapy, utilize data from the PROMINENT trial and other databases, and validate findings in real-world settings.
Language	English
Publishing date	2024-04-25
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	186196-7
ISSN	1365-2362 ; 0014-2972 ; 0960-135X
ISSN (online)	1365-2362
ISSN	0014-2972 ; 0960-135X
DOI	10.1111/eci.14227
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Article ; Online: Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033).

Suzuki, Hiroko / Fujita, Hidetoshi / Iwai, Kazuyuki / Kuroki, Haruo / Taniyama, Kazuhiko / Shizuya, Toshiyuki / Kishino, Hiroyuki / Igarashi, Rie / Shirakawa, Masayoshi / Sawata, Miyuki

Vaccine

2023 Volume 41, Issue 34, Page(s) 4933–4940

Abstract: Background: This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in Japanese infants. V114 contains all 13 serotypes in PCV13 plus additional serotypes 22F and 33F.: Methods: ... ...

Abstract	Background: This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in Japanese infants. V114 contains all 13 serotypes in PCV13 plus additional serotypes 22F and 33F. Methods: Healthy Japanese infants were randomized to receive three primary doses of V114 or PCV13 (dose 1 at 2-6 months of age; doses 2 and 3 ≥ 27 days after prior dose), plus a toddler dose at 12-15 months of age. Adverse events (AEs) were collected on Days 1-14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-dose 3, pre-dose 4, and 30 days post-dose 4. Primary objectives included non-inferiority of V114 to PCV13 for the 13 shared serotypes based on serotype-specific IgG response rates (IgG ≥ 0.35 μg/mL) and geometric mean concentration (GMC) ratios, and for serotypes 22F and 33F based on IgG response rates and compared with the lowest response of any serotype in the PCV13 group, at 30 days post-dose 3. Results: Overall, 694 infants were randomized to V114 (n = 347) or PCV13 (n = 347). Proportions of participants with solicited and serious AEs were comparable between vaccination groups. V114 met non-inferiority criteria for all 13shared serotypes, based on difference in proportion of responders (lower bound of two-sided 95 % confidence interval [CI] > -10.0) and IgG GMC ratios (V114/PCV13, lower bound of two-sided 95 % CI > 0.5) at 30 days post-dose 3. The non-inferiority criterion based on IgG response rates was met for serotype 22F, but narrowly missed for serotype 33F (90.9 %, lower bound of two-sided 95 % CI -10.6). Conclusion: In Japanese infants, a four-dose series of V114 was generally well tolerated. Compared with PCV13, V114 provided non-inferior immune responses to the 13 shared serotypes and higher immune responses to serotype 22F and 33F post-primary series. Trial registration: ClinicalTrials.gov: NCT04384107; EudraCT 2019-003644-68.
MeSH term(s)	Humans ; Infant ; Vaccines, Conjugate ; Pneumococcal Infections ; East Asian People ; Antibodies, Bacterial ; Immunoglobulin G ; Pneumococcal Vaccines ; Immunogenicity, Vaccine
Chemical Substances	Vaccines, Conjugate ; Antibodies, Bacterial ; Immunoglobulin G ; Pneumococcal Vaccines
Language	English
Publishing date	2023-06-19
Publishing country	Netherlands
Document type	Clinical Trial, Phase III ; Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.05.064
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Article ; Online: Removal of the block to self-fertilization by low-calcium artificial seawater in the ascidian

Hashimoto, Shizuya / Kinjo, Keita / Saito, Takako / Sawada, Hitoshi

Zygote (Cambridge, England)

2022 Volume 30, Issue 5, Page(s) 738–742

Abstract: Ascidians (Urochordate) are hermaphroditic marine invertebrates that release sperm and eggs to the surrounding seawater. However, several ascidians, ... ...

Abstract	Ascidians (Urochordate) are hermaphroditic marine invertebrates that release sperm and eggs to the surrounding seawater. However, several ascidians, including
MeSH term(s)	Animals ; Calcium/metabolism ; Ciona intestinalis ; Fertilization ; Infertility ; Male ; Seawater ; Self-Fertilization ; Semen ; Spermatozoa/metabolism ; Urochordata ; Vitelline Membrane/metabolism
Chemical Substances	Calcium (SY7Q814VUP)
Language	English
Publishing date	2022-06-10
Publishing country	England
Document type	Journal Article
ZDB-ID	1166294-3
ISSN	1469-8730 ; 0967-1994
ISSN (online)	1469-8730
ISSN	0967-1994
DOI	10.1017/S0967199422000144
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Article ; Online: Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial.

Arai, Hidenori / Yamashita, Shizuya / Araki, Eiichi / Yokote, Koutaro / Tanigawa, Ryohei / Saito, Ayumi / Yamasaki, Sayumi / Suganami, Hideki / Ishibashi, Shun

Journal of atherosclerosis and thrombosis

2024

Abstract: Aims: Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator that lowers serum triglyceride levels and increases high-density lipoprotein cholesterol levels, is approved for treating dyslipidemia as twice-daily immediate-release ...

Abstract	Aims: Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator that lowers serum triglyceride levels and increases high-density lipoprotein cholesterol levels, is approved for treating dyslipidemia as twice-daily immediate-release (IR) tablets. A once-daily extended-release (XR) tablet has also been developed. We aimed to confirm the non-inferiority of XR (0.2 or 0.4 mg/day; once daily) to IR (0.2 mg/day; twice daily) in lowering triglyceride levels in patients with hypertriglyceridemia. Methods: This phase 3, multicenter, randomized, double-blind study included patients with fasting triglycerides ≥ 200 mg/dL who received IR (0.2 mg/day) or XR (0.2 or 0.4 mg/day). The primary efficacy endpoint was the percentage change in fasting triglyceride levels from baseline to 4, 8, and 12 weeks. Common treatment effects at weeks 4 through 12 were compared between groups using repeated analysis of covariance. Results: In 356 randomized patients, fasting triglyceride levels decreased by 48.0%, 43.8%, and 48.0% with IR 0.2, XR 0.2, and XR 0.4 mg/day, respectively, confirming the non-inferiority of both XR regimens to IR. The proportion of patients who achieved fasting triglycerides ＜150 mg/dL was 45.7%, 37.4%, and 51.7%, while the percentage change of triglycerides in the subgroup with baseline triglycerides ≥ 500 mg/dL was -59.3%, -52.2%, and -66.3% with IR 0.2, XR 0.2, and XR 0.4 mg/day, respectively. Conclusions: XR (0.2 and 0.4 mg/day) was non-inferior to IR (0.2 mg/day). XR 0.4 mg/day demonstrated a more potent triglyceride-lowering effect than XR 0.2 mg/day and should be considered for patients with high triglyceride levels.
Language	English
Publishing date	2024-04-13
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2011474-6
ISSN	1880-3873 ; 1340-3478
ISSN (online)	1880-3873
ISSN	1340-3478
DOI	10.5551/jat.64677
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Zs.A 5192: Show issues

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Article: Safety and Pitfalls of Blepharoptosis Surgery in Elderly People.

Shirakawa, Yuji / Uemura, Kazuhisa / Kumegawa, Shinji / Ueno, Kazuki / Iwanishi, Hiroki / Saika, Shizuya / Asamura, Shinichi

Archives of plastic surgery

2023 Volume 50, Issue 5, Page(s) 446–451

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2023-08-28
Publishing country	Korea (South)
Document type	Journal Article
ZDB-ID	2694943-X
ISSN	2234-6171 ; 2234-6163
ISSN (online)	2234-6171
ISSN	2234-6163
DOI	10.1055/s-0043-1770082
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Article ; Online: Achievement Rates for Low-Density Lipoprotein Cholesterol Goals in Patients at High Risk of Atherosclerotic Cardiovascular Disease in a Real-World Setting in Japan.

Mitani, Hironobu / Suzuki, Kota / Ako, Junya / Iekushi, Kazuma / Majewska, Renata / Touzeni, Salsabil / Yamashita, Shizuya

Journal of atherosclerosis and thrombosis

2023 Volume 30, Issue 11, Page(s) 1622–1634

Abstract: Aims: The study aimed to investigate low-density lipoprotein cholesterol (LDL-C) goal achievement rates in patients receiving LDL-C-lowering therapy using recent real-world data, following the 2017 revision of the Japan Atherosclerosis Society ... ...

Abstract	Aims: The study aimed to investigate low-density lipoprotein cholesterol (LDL-C) goal achievement rates in patients receiving LDL-C-lowering therapy using recent real-world data, following the 2017 revision of the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (JAS GL2017). Methods: Patients with documented LDL-C test results were extracted from the Medical Data Vision claims database between July 2018 and June 2021 and divided into three groups according to JAS GL2017: primary prevention high risk (Group I, LDL-C goal ＜120 mg/dL), secondary prevention (Group II, LDL-C goal ＜100 mg/dL), and secondary prevention high risk (Group III, LDL-C goal ＜70 mg/dL). Results: The mean LDL-C value was 108.7 mg/dL (n=125,235), 94.4 mg/dL (n=57,910), and 90.6 mg/dL (n=33,850) in Groups I, II, and III, respectively. Intensive statin monotherapy (pitavastatin, rosuvastatin, or atorvastatin) was the most frequently prescribed lipid-lowering treatment (21.6%, 30.8%, and 42.7% in Groups I, II, and III, respectively), followed by ezetimibe (2.5%, 7.1%, and 8.5% in Groups I, II, and III, respectively). LDL-C goals were achieved by 65.5%, 60.6%, and 25.4% of patients overall in Groups I, II, and III, respectively. Achievement rates were 83.9%, 75.3%, and 29.5% in patients prescribed intensive statin monotherapy and 82.3%, 86.4%, and 46.4% in those prescribed statin and ezetimibe combinations in Groups I, II, and III, respectively. In Group III, the proportion of patients with familial hypercholesterolemia prescribed statin and ezetimibe combinations achieving LDL-C goals was low (32.5%). Conclusions: The proportion of patients achieving LDL-C goals for secondary prevention in the high-risk group remains low even with statin and ezetimibe combination therapy.
MeSH term(s)	Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Cholesterol, LDL ; Goals ; Cardiovascular Diseases/drug therapy ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/prevention & control ; Japan/epidemiology ; Treatment Outcome ; Ezetimibe/therapeutic use ; Atherosclerosis/drug therapy ; Atherosclerosis/epidemiology ; Atherosclerosis/prevention & control ; Anticholesteremic Agents
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Cholesterol, LDL ; Ezetimibe (EOR26LQQ24) ; Anticholesteremic Agents
Language	English
Publishing date	2023-03-16
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2011474-6
ISSN	1880-3873 ; 1340-3478
ISSN (online)	1880-3873
ISSN	1340-3478
DOI	10.5551/jat.63940
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Zs.A 5192: Show issues

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Article: Cyclohelminthol CPs: Scope and Limitations of Density Functional Theory-Based Structural Elucidation of Natural Products

Inose, Kota / Tanaka, Shizuya / Tanaka, Kazuaki / Hashimoto, Masaru

Journal of organic chemistry. 2021 Jan. 07, v. 86, no. 2

2021

Abstract: ... analyses. The structures were verified with reference to DFT-derived ¹³C and ¹H NMR chemical shifts, ³JHH ... moiety. However, ¹H chemical shift calculations compensated for the imperfection of the latter. ECD ...

Abstract	The effectiveness and limitations of density functional theory (DFT) calculations in the structural determination of complexed and conformationally flexible natural products were demonstrated using the cyclohelminthols CP-1 (1) CP-2 (2), CP-3 (3), and CP-4 (4) newly isolated from Helminthosporium velutinum yone96. Prior to DFT calculations, the structures were tentatively assigned using conventional spectroscopic analyses. The structures were verified with reference to DFT-derived ¹³C and ¹H NMR chemical shifts, ³JHH and ⁿJCH values, and electronic circular dichroism (ECD) spectra. The ¹³C chemical shift calculations were very effective for verifying the ring-structure moieties but less effective for verifying the geometry of the side chain in which the juncture asymmetric carbon (C-16) was apart from the ring-structure moiety. However, ¹H chemical shift calculations compensated for the imperfection of the latter. ECD spectral calculations were used to determine the absolute configurations. Calculations for virtual simple model molecules enabled us to evaluate the reliability of the ECD spectral calculation and derive the chiral torsion responsible for the characteristic Cotton effects.
Keywords	Helminthosporium ; carbon ; circular dichroism spectroscopy ; density functional theory ; geometry ; moieties ; organic chemistry
Language	English
Dates of publication	2021-0107
Size	p. 1505-1515.
Publishing place	American Chemical Society
Document type	Article
ZDB-ID	123490-0
ISSN	1520-6904 ; 0022-3263
ISSN (online)	1520-6904
ISSN	0022-3263
DOI	10.1021/acs.joc.0c02378
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Efficacy, Safety, and Pharmacokinetics of Inclisiran in Japanese Patients: Results from ORION-15.

Yamashita, Shizuya / Kiyosue, Arihiro / Maheux, Pierre / Mena-Madrazo, Jorge / Lesogor, Anastasia / Shao, Qing / Tamaki, Yuko / Nakamura, Hidekazu / Akahori, Mizuki / Kajinami, Kouji

Journal of atherosclerosis and thrombosis

2024

Abstract: ... compared to 8.9% for placebo. The mean (SD) plasma half-life for inclisiran was 6.8 (2.0)-7.6 (0.8) h ...

Abstract	Aim: To evaluate the efficacy, safety, and pharmacokinetics (PK) of inclisiran in Japanese patients with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C). Methods: ORION-15 was a phase 2, double-blind, placebo-controlled randomized trial. Patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), were randomized to inclisiran sodium 100, 200, or 300 mg, or placebo and dosed subcutaneously on Days 1, 90, and 270. T he primary endpoint was the percentage change from baseline to Day 180 to demonstrate the superiority of inclisiran vs. placebo. Patients who consented to the PK substudy had additional study procedures for blood collection and safety assessment. Results: Overall, 312 patients (mean age, 63.6 years; male, 74.4%; baseline LDL-C, 114.0 mg/dL) were randomized. Baseline characteristics were well balanced among the groups. At Day 180, inclisiran at all doses demonstrated significant LDL-C and proprotein convertase subtilisin/kexin type 9 (PCSK9) reductions (p＜0.0001 for both), which showed a dose-response relationship. The greatest reductions (LDL-C, 65.3%; PCSK9, 79.2%) were with inclisiran sodium 300 mg. At Day 180, ＞86% of the patients receiving inclisiran achieved the Japan Atherosclerosis Society 2017 lipid management targets compared to 8.9% for placebo. The mean (SD) plasma half-life for inclisiran was 6.8 (2.0)-7.6 (0.8) h. The incidence of adverse events with inclisiran was similar to that with placebo. Conclusion: Inclisiran sodium 100, 200, and 300 mg demonstrated clinically meaningful and statistically significant LDL-C and PCSK9 reductions at Day 180, which were consistent over 12 months. Inclisiran was effective and well tolerated in Japanese patients with hypercholesterolemia, including HeFH.
Language	English
Publishing date	2024-01-14
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2011474-6
ISSN	1880-3873 ; 1340-3478
ISSN (online)	1880-3873
ISSN	1340-3478
DOI	10.5551/jat.64454
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Article ; Online: Delayed regression of laser-induced choroidal neovascularization in TNFα-null mice.

Iwanishi, Hiroki / Yamanaka, Osamu / Sumioka, Takayoshi / Yasuda, Shingo / Miyajima, Masayasu / Saika, Shizuya

Journal of cellular and molecular medicine

2022 Volume 26, Issue 20, Page(s) 5315–5325

Abstract: We investigated the effects of lacking TNFα on the development and regression of Argon-laser-induced choroidal neovascularization (CNV) in mice. We lasered ocular fundus for induction of CNV in both wild-type (WT) and TNFα-null (KO) mice. Fluorescence ... ...

Abstract	We investigated the effects of lacking TNFα on the development and regression of Argon-laser-induced choroidal neovascularization (CNV) in mice. We lasered ocular fundus for induction of CNV in both wild-type (WT) and TNFα-null (KO) mice. Fluorescence angiography was performed to examine the size of CNV lesions. Gene expression pattern of wound healing-related components was examined. The effects of exogenous TNFα on apoptosis of human retinal microvascular endothelial cells (HRMECs) and on the tube-like structure of the cells were investigated in vitro. The results showed that Argon-laser irradiation-induced CNV was significantly larger in KO mice than WT mice on Day 21, but not at other timepoints. Lacking TNFα increased neutrophil population in the lesion. The distribution of cleaved caspase3-labelled apoptotic cells was more frequently observed in the laser-irradiated tissue in a WT mouse as compared with a KO mouse. Exogenous TNFα induced apoptosis of HRMECs and accelerated regression of tube-like structure of HRMECs in cell culture. Taken together, TNFα gene knockout delays the regression of laser-induced CNV in mice. The mechanism underlying the phenotype might include the augmentation of neutrophil population in the treated tissue and attenuation of vascular endothelial cell apoptosis.
MeSH term(s)	Animals ; Argon ; Choroidal Neovascularization/genetics ; Choroidal Neovascularization/metabolism ; Disease Models, Animal ; Endothelial Cells/metabolism ; Humans ; Lasers ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Tumor Necrosis Factor-alpha
Chemical Substances	Tumor Necrosis Factor-alpha ; Argon (67XQY1V3KH)
Language	English
Publishing date	2022-09-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2074559-X
ISSN	1582-4934 ; 1582-4934 ; 1582-1838
ISSN (online)	1582-4934
ISSN	1582-4934 ; 1582-1838
DOI	10.1111/jcmm.17562
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Article ; Online: Minimally Invasive Two-Stage Procedure of Aorto-Bi-Iliac Stent-Graft Implantation Performed in a Patient with an Abdominal Aortic Aneurysm and Long-Segment Iliac Artery Occlusion: A Case Report.

Shintomi, Shizuya / Azuma, Takashi / Taguchi, Tetsuya / Domoto, Satoru / Saito, Satoshi / Niinami, Hiroshi

The American journal of case reports

2022 Volume 23, Page(s) e937508

Abstract: BACKGROUND Patients with an abdominal aortic aneurysm and long-segment iliac artery occlusion are usually treated with aorto-uni-iliac stent-graft implantation with femoro-femoral crossover bypass. However, it is more invasive than aorto-bi-iliac stent- ... ...

Abstract	BACKGROUND Patients with an abdominal aortic aneurysm and long-segment iliac artery occlusion are usually treated with aorto-uni-iliac stent-graft implantation with femoro-femoral crossover bypass. However, it is more invasive than aorto-bi-iliac stent-graft implantation and poses patency issues. Herein, we describe a minimally invasive two-stage procedure of aorto-bi-iliac stent-graft implantation following iliac artery endovascular recanalization. CASE REPORT A 76-year-old man was diagnosed with an abdominal aortic aneurysm and long-segment left iliac artery occlusion. Abdominal aortic aneurysm was diagnosed during the examination of lower back pain. There were no other symptoms, including intermittent claudication. Factoring in his frail constitution and multiple comorbidities, we decided to perform aorto-bi-iliac stent-graft implantation after iliac artery endovascular recanalization to improve the patency of the left iliac artery. Aorto-bi-iliac stent-graft implantation was performed 2 days after iliac artery endovascular recanalization to avoid distal embolization. The postoperative course and 1-year follow-up were uneventful, with computed tomography revealing no endoleak and good patency. CONCLUSIONS The stent-graft implantation used in this patient is minimally invasive and results in good patency while reducing the risk of embolization. Furthermore, the long-term outcome of aorto-bi-iliac stent-graft implantation following iliac artery endovascular recanalization is more favorable than that involving treatment with aorto-uni-iliac stent-graft implantation with femoro-femoral crossover bypass.
MeSH term(s)	Male ; Humans ; Aged ; Aortic Aneurysm, Abdominal/diagnostic imaging ; Aortic Aneurysm, Abdominal/surgery ; Iliac Artery/diagnostic imaging ; Iliac Artery/surgery ; Blood Vessel Prosthesis Implantation/methods ; Embolization, Therapeutic ; Treatment Outcome ; Stents ; Iliac Aneurysm/surgery ; Endovascular Procedures
Language	English
Publishing date	2022-11-12
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	2517183-5
ISSN	1941-5923 ; 1941-5923
ISSN (online)	1941-5923
ISSN	1941-5923
DOI	10.12659/AJCR.937508
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