著者
Yoichi Sugiyama Noriaki Moriyama Hirokazu Miyashita Hiroaki Yokoyama Tomoki Ochiai Koki Shishido Mikko Jalanko Futoshi Yamanaka Tommi Vähäsilta Mika Laine Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0593, (Released:2023-11-28)
参考文献数
23
被引用文献数
1

Background: Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death.Conclusions: In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.
著者
Shigeru Saito Seiji Yamazaki Akihiko Takahashi Atsuo Namiki Tomohiro Kawasaki Satoru Otsuji Shigeru Nakamura Yoshisato Shibata for the Disrupt CAD IV Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.85, no.6, pp.826-833, 2021-05-25 (Released:2021-05-25)
参考文献数
31
被引用文献数
2 58

Background:Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance and optimize stent deployment. The objective of this study was to assess the safety and effectiveness of IVL treatment of de novo stenoses involving severely calcified coronary vessels in a Japanese population.Methods and Results:Disrupt CAD IV (NCT04151628) was a prospective, multicenter study designed for Japanese regulatory approval of coronary IVL (SWM-1234). The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days. The primary effectiveness endpoint was procedural success (residual stenosis <50% by QCA without in-hospital MACE). Noninferiority analyses for the primary endpoints were performed by comparing the CAD IV cohort with a propensity-matched historical IVL control group. Patients (intent-to-treat, n=64) were enrolled from 8 centers in Japan. Severe calcification by core laboratory assessment was present in all lesions, with a calcified length of 49.8±15.5 mm and a calcium angle of 257.9±78.4° by optical coherence tomography. Primary endpoints were achieved with non-inferiority demonstrated for freedom from 30-day MACE (CAD IV: 93.8% vs. Control: 91.2%, P=0.008), and procedural success (CAD IV: 93.8% vs. Control: 91.6%, P=0.007). No perforations, abrupt closures, or slow/no-reflow events occurred at any time during the procedures.Conclusions:Coronary IVL demonstrated high procedural success with low MACE rates in severely calcified lesions in a Japanese population.
著者
Shigeru Saito Takaaki Isshiki Takeshi Kimura Hisao Ogawa Hiroyoshi Yokoi Shinsuke Nanto Morimasa Takayama Kazuo Kitagawa Masakatsu Nishikawa Shunichi Miyazaki Masato Nakamura
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.78, no.7, pp.1684-1692, 2014 (Released:2014-06-25)
参考文献数
14
被引用文献数
44 253

Background: Prasugrel is an antiplatelet agent that shows more prompt, potent, and consistent platelet inhibition than clopidogrel. The objective of this study was to confirm the efficacy and safety of prasugrel at loading/maintenance doses of 20/3.75mg. Methods and Results: Japanese patients (n=1,363) with acute coronary syndrome undergoing percutaneous coronary intervention were randomized to either prasugrel (20/3.75mg) or clopidogrel (300/75mg), both in combination with aspirin (81–330mg for the first dose and 81–100mg/day thereafter), for 24–48 weeks. The primary efficacy endpoint was the incidence of major adverse cardiovascular events (MACE) at 24 weeks, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke. We compared the incidence of MACE between the 2 groups using point estimates. Safety outcomes included the incidence of bleeding events until 2 weeks after the last dose. The incidence of MACE at 24 weeks was 9.4% in the prasugrel group and 11.8% in the clopidogrel group (risk reduction 23%, hazard ratio 0.77, 95% confidence interval 0.56–1.07). The incidence of non-coronary artery bypass graft-related major bleeding was similar in both groups (1.9% vs. 2.2%). Conclusions: Prasugrel 20/3.75mg was associated with a low incidence of ischemic events, similar to the results of TRITON-TIMI 38, and with a low risk of clinically serious bleeding in Japanese ACS patients.  (Circ J 2014; 78: 1684–1692)
著者
Shigeru Saito Seiji Yamazaki Akihiko Takahashi Atsuo Namiki Tomohiro Kawasaki Satoru Otsuji Shigeru Nakamura Yoshisato Shibata
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
pp.CR-23-0082, (Released:2023-11-29)
参考文献数
22

Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population.
著者
Kazutaka Aonuma Hiro Yamasaki Masato Nakamura Takashi Matsumoto Morimasa Takayama Kenji Ando Kenzo Hirao Masahiko Goya Yoshihiro Morino Kentaro Hayashida Kengo Kusano Yutaka Gomi Michael L. Main Takahiro Uchida Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-20-0196, (Released:2020-06-26)
参考文献数
16
被引用文献数
15

Background:The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score.Conclusions:Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)
著者
Kazutaka Aonuma Hiro Yamasaki Masato Nakamura Tatsushi Ootomo Morimasa Takayama Kenji Ando Kenzo Hirao Yoshihiro Morino Kentaro Hayashida Kengo Kusano Michael L. Main Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.82, no.12, pp.2946-2953, 2018-11-24 (Released:2018-11-24)
参考文献数
22
被引用文献数
34

Background: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up. Conclusions: The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)
著者
齊藤 茂 北村 勝朗 永山 貴洋 Shigeru Saito Katsuro Kitamura Takahiro Nagayama
雑誌
教育情報学研究 = Educational informatics research (ISSN:13481983)
巻号頁・発行日
vol.6, pp.45-53, 2007-07-01

スポーツ選手の練習の「質」を分けるものは何であろうか。本研究では,ユース年代のエキスパート・サッカー選手9名を対象として,彼らが熟達してきた過程において,どのような意識のもと,能動的に練習活動に取り組んできたのか,対象者が行ってきた練習の「質」の詳細を描写することを目的とした。本研究のデータ収集は,筆者と対象者による1対1の半構造的インタビューにより実施し,定性的データ分析法に基づき分析が進められた。結果として,対象者は,目標を高い基準に保持し,的確な現状把握することにより必要性を検知するといった「モニタリング」を積極的に行っていること,および練習環境の再考し,意味のある環境で練習をする中で練習環境を構築し続けていくこと,さらにはこうした要因が相互に作用して練習の「質」を高めているという対象者の意識の構造が明らかとなった。
著者
Yoshimitsu Soga Osamu Iida Masahiko Fujihara Daizo Kawasaki Shigeru Saito Kazushi Urasawa Hiroyoshi Yokoi Eric J. Fernandez Jia Guo Masato Nakamura on behalf of the IN.PACT Japan Post-Market Surveillance Study
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-21-0491, (Released:2021-10-06)
参考文献数
27
被引用文献数
4

Background:To confirm the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) based on the indication approved by the Pharmaceuticals and Medical Devices Agency Japan in real-world patients with femoropopliteal artery disease.Methods and Results:IN.PACT PMS Japan was a prospective, multicenter, single-arm, post-market surveillance (PMS) study conducted in Japan that enrolled 304 participants (mean age 75.3±7.9 years). The primary endpoint was primary patency at 6 months following the index procedure, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤2.4 (assessed by the independent DUS core laboratory). Secondary endpoints included acute outcomes, primary patency at 12 months post-index procedure, freedom from CD-TLR, and major adverse events at 12 months. The mean lesion length was 97.81±58.97 mm. The primary endpoint, 6-month primary patency, was 91.3% (240/263). Kaplan-Meier estimates of primary patency and freedom from CD-TLR through 12 months were 91.5% and 94.1%, respectively. The CD-TLR rate was 5.8% (14/240) with low rates of thrombosis (0.8%) and target limb amputation (0.4%) at 12 months.Conclusions:The results of this real-world PMS study were consistent with outcomes from previous IN.PACT DCB studies, confirming the safety and efficacy of the IN.PACT Admiral DCB for broader use in patients seen in everyday practice.
著者
Masato Nakamura Kazushige Kadota Koichi Nakao Yoshihisa Nakagawa Junya Shite Hiroyoshi Yokoi Ken Kozuma Kengo Tanabe Takashi Akasaka Toshiro Shinke Takafumi Ueno Atsushi Hirayama Shiro Uemura Atsushi Harada Takeshi Kuroda Atsushi Takita Raisuke Iijima Yoshitaka Murakami Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-20-1058, (Released:2021-02-11)
参考文献数
20
被引用文献数
9

Background:Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown.Methods and Results:Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9–4.2) and 4.1% (95% CI, 3.3–5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45–1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7–5.3) and 5.6% (95% CI, 4.7–6.7), respectively (HR, 0.68; 95% CI, 0.47–0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63–1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61–1.19; P=0.348) between the groups.Conclusions:Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.
著者
Kazuomi Kario Eiichiro Yamamoto Hirofumi Tomita Takafumi Okura Shigeru Saito Takafumi Ueno Daiki Yasuhara Kazuyuki Shimada on behalf of the SYMPLICITY HTN-Japan Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-18-1018, (Released:2019-02-13)
参考文献数
32
被引用文献数
27

Background: SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal denervation (RDN) with standard pharmacologic therapy for treatment of uncontrolled hypertension (HTN). Methods and Results: Patients enrolled had uncontrolled HTN, defined as office systolic blood pressure (SBP) ≥160 mmHg and 24-h ambulatory SBP ≥135 mmHg, on ≥3 antihypertensive drugs of maximally tolerated dose for at least 6 weeks prior to enrollment. Randomization was 1:1 to RDN or maintenance of current medical therapy (control). Patients were followed every 6 months post-randomization for up to 36 months. There were 22 patients randomized to RDN and 19 to control, and 11 patients were crossed over and received RDN at 6 months post-randomization. For the RDN group (n=22), office SBP reduction was −32.8±20.1 mmHg and office DBP reduction was −15.8±12.6 mmHg at 36 months post-procedure, both P<0.001. For the combined RDN and crossover group (n=33), office SBP reduction was −26.7±18.9 mmHg and office DBP reduction was −12.7±11.8 mmHg at 30 months post-procedure, both P<0.001. There were no procedural-, device- or treatment-related safety events through 36 months. Conclusions: SYMPLICTY HTN-Japan is the first randomized controlled trial to evaluate RDN in an Asian population. Despite the small number of enrollments, results show patients who received RDN therapy maintained SBP reduction out to 36 months.
著者
Kazuomi Kario Hisao Ogawa Ken Okumura Takafumi Okura Shigeru Saito Takafumi Ueno Russel Haskin Manuela Negoita Kazuyuki Shimada on behalf of the SYMPLICITY HTN-Japan Investigators
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-15-0150, (Released:2015-04-24)
参考文献数
28
被引用文献数
20 75

Background:SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal artery denervation (RDN) with standard pharmacotherapy for treatment of resistant hypertension (systolic blood pressure [SBP] ≥160 mmHg on ≥3 anti-hypertensive drugs including a diuretic for ≥6 weeks). When SYMPLICITY HTN-3 failed to meet the primary efficacy endpoint, the HTN-Japan enrollment was discontinued before completion.Methods and Results:The 6-month change in office and 24-h ambulatory SBP were compared between RDN (n=22) and control (n=19) subjects. Mean baseline office SBP was 181.0±18.0 mmHg and 178.7±17.8 mmHg for the RDN and control groups, respectively. The 6-month office SBP change was –16.6±18.5 mmHg for RDN subjects (P<0.001) and –7.9±21.0 mmHg for control subjects (P=0.117); the difference between the 6-month change in RDN and control subjects was –8.64 (95% CI: –21.12 to 3.84, P=0.169). Mean 24-h SBP was 164.7±18.3 (RDN group) and 163.3±17.2 mmHg (control group). The 24-h 6-month SBP change for the RDN group was –7.52±11.98 mmHg (P=0.008) and –1.38±10.2 mmHg (P=0.563) for control subjects; the between-group difference in SBP change was –6.15 (95% CI: –13.23 to 0.94, P=0.087). No major adverse events were reported.Conclusions:SYMPLICITY HTN-Japan, the first randomized controlled trial of RDN in an Asian population, was underpowered for the primary endpoint analysis and did not demonstrate a significant difference in 6-month BP change between RDN and control subjects.
著者
中村 靖 斉藤 茂 山崎 健一 柴崎 好伸 Yasushi NAKAMURA Shigeru SAITO Kenichi YAMASAKI Yoshinobu SHIBASAKI 昭和大学歯学部歯科矯正学教室 昭和大学歯学部歯科矯正学教室 昭和大学歯学部歯科矯正学教室 昭和大学歯学部歯科矯正学教室 Department of Orthodontics School of Dentistry Showa University Department of Orthodontics School of Dentistry Showa University Department of Orthodontics School of Dentistry Showa University Department of Orthodontics School of Dentistry Showa University
雑誌
日本矯正歯科学会雑誌 = The journal of Japan Orthodontic Society (ISSN:0021454X)
巻号頁・発行日
vol.54, no.3, pp.159-169, 1995-06
参考文献数
47
被引用文献数
4

矯正学的歯の移動時には, 歯槽骨を形成している細胞と歯根膜細胞が矯正力というmechanical stressに対してさまざまな反応を示すことが知られている.そこで本研究は同一外科矯正患者から同時に採取した下顎骨片と健全な下顎第一小臼歯から骨系細胞と歯根膜細胞を剥離して培養した.両細胞に間欠的遠心力(50&acd;250回転)を付与し, DNA合成能, 細胞内アルカリフォスファターゼ(ALPase)活性, サイクリックAMP(cAMP)産生量, プロスタグランディンE_2(PGE_2)産生量, インターロイキン6(IL-6)産生量, 骨吸収能を測定した.両細胞に付与した間欠的遠心力が上記測定項目に対してどのような影響を与えるかを検討し, あわせて両細胞の反応性の相違についても比較検討した.その結果, 1. DNA合成能および細胞内ALPase活性は, 250回転において両細胞とも有意に促進された.2. 骨系細胞において, 遠心力の付与によりすべての回転数でcAMPおよびPGE_2産生量が有意に抑制され, IL-6産生量に関しても50回転において抑制傾向があった.3. 歯根膜細胞においては, 遠心力を付与してもcAMP, PGE_2, IL-6の産生量がほとんど変化しなかった.4. 骨吸収能は遠心力を付与した培養上清を用いると両細胞とも150回転で有意に抑制された.以上のことから, DNA合成能と細胞内ALPase活性は高回転の間欠的遠心力に対して両細胞とも促進することが示された.また, 骨系細胞の骨吸収能はPGE_2, IL-6の影響を直接的に受けやすいが, 歯根膜細胞に関してはPGE_2, IL-6以外にも骨吸収能に影響を与える何らかの因子が存在することも示唆された.It has been shown that bone cells and periodontal ligament (PDL) cells have various responses to mechanical stress during orthodontic tooth movement. The following experiments were performed to compare the responses of these two cell types to mechanical stress. Cortical bone specimens derived from mandible and PDL of first premolars were obtained at the same time from the same patient undergoing surgical orthodontics. In the confluent phase, intermittent centrifugal forces (ICF) were applied to the cultured bone cells and PDL cells at 50&acd;250 rpm. After centrifugation, the cultured cells were used for the assays of DNA synthesis, alkaline phosphatase (ALPase) activity and cyclic AMP (cAMP) production, and the cultured media were used for the assays of prostaglandin E_2 (PGE_2) production, interleukin-6 (IL-6) production and bone resorption activity. The results were as follows : 1. ICF at 250 rpm significantly induced DNA synthesis and ALPase activity in each cell type. 2. In bone cells, the amounts of cAMP and PGE_2 were significantly decreased by ICF at all magnitudes of force tested, and those of IL-6 tended to be decreased by ICF at 50 rpm. 3. In PDL cells, the amounts of cAMP, PGE_2 and IL-6 were hardly changed by ICF at all magnitudes of force tested. 4. ICF at 150 rpm significantly inhibited the bone resorption activity in each cell type. These results suggested that DNA synthesis and ALPase activity are stimulated by high-speed ICF in each cell type. These results also suggested that bone resorption activity caused by ICF in bone cells was directly affected by PGE_2 and IL-6. However, in PDL cells, there may be agents that affect bone resorption activity other than PGE_2 and IL-6.