著者

Hong Li Qiang Liu Ningfu Wang Yizhou Xu Lan Kang Yaqi Ren Gangjie Zhu

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.82, no.9, pp.2332-2341, 2018-08-24 (Released:2018-08-24)

参考文献数

37

被引用文献数

7 18

---

Background: In a previous study, a low level of miR-126-3p in endothelial progenitor cells (EPCs) was linked to the outcome of ischemic cardiomyopathy (ICM) patients. However, it remains unclear whether transplantation with miR-126-3p-overexpressing EPCs (MO-EPCs) can improve the cardiac function of ICM animal models. Methods and Results: miR-126-3p overexpression by lentiviral vector significantly increased migration and tube-like structures of EPCs from ICM patients. MO-EPCs or non-modified EPCs (NM-EPCs) were transplanted into nude rats with ICM induced by coronary artery ligation. MO-EPC transplantation increased capillary density and EPC survival rate in myocardial tissues of nude rats. Cytokines were also assessed by antibody array and real-time RT-PCR. G-CSF, VEGF-A, IL-3, IL-10, IGF-1, angiogenin, HGF, TIMP-1 and TIMP-2 were upregulated, and IL-8, MCP-1, MCP-2, TNF-α, TNF-β and MIP-1β were downregulated after miR-126-3p overexpression in EPCs. The same results were obtained in infarction tissues of nude rats after MO-EPC transplantation. Eight weeks after MO-EPC transplantation, left ventricular function improved significantly with clearly decreased infarction size, increased anterior wall thickness, and inhibition of inflammation compared with the results for NM-EPC transplantation. However, MO-EPC transplantation showed no increase in survival time of nude rats with ICM during 8 weeks of observation. Conclusions: miR-126-3p can restore the biology of EPCs from ICM patients. Moreover, MO-EPC transplantation improves cardiac function effectively, representing a promising future treatment for ICM.

著者

Takanori Ikeda Takeshi Yamashita Masaharu Akao Hirotsugu Atarashi Yukihiro Koretsune Ken Okumura Wataru Shimizu Hiroyuki Tsutsui Kazunori Toyoda Atsushi Hirayama Masahiro Yasaka Takenori Yamaguchi Satoshi Teramukai Tetsuya Kimura Jumpei Kaburagi Atsushi Takita Hiroshi Inoue

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.86, no.2, pp.202-210, 2022-01-25 (Released:2022-01-25)

参考文献数

41

被引用文献数

3

---

Background:Data on outcomes for patients with atrial fibrillation (AF) and active cancer are scarce. The effect of active cancer on thrombosis and bleeding risks in elderly (≥75 years) patients with non-valvular AF (NVAF) enrolled in the All Nippon AF In the Elderly (ANAFIE) Registry were prospectively analyzed.Methods and Results:In this subanalysis of the ANAFIE Registry, a prospective, multicenter, observational study conducted in Japan, we compared the incidence rates of clinical outcomes between active cancer and non-cancer groups. Relationships between primary outcomes and anticoagulation status were evaluated. Of the 32,725 patients enrolled in the Registry, 3,569 had active cancer at baseline; 92.0% of active cancer patients received anticoagulants (23.7%, warfarin; 68.2%, direct oral anticoagulants [DOACs]). Two-year probabilities of stroke/systemic embolic events (SEE) were similar in the cancer (3.33%) and non-cancer (3.16%) groups. Patients with cancer had greater incidences of major bleeding (2.86% vs. 2.04%), all-cause death (10.95% vs. 6.77%), and net clinical outcomes (14.63% vs. 10.00%) than those without cancer. In patients without cancer, DOACs were associated with a decreased risk of stroke/SEE, major bleeding, all-cause death, and net clinical outcome compared with warfarin. No between-treatment differences were observed in patients with active cancer.Conclusions:Active cancer had no effect on stroke/SEE incidence in elderly NVAF patients, but those with cancer had higher incidences of major bleeding events and all-cause death than those without cancer.

著者

Hitonobu Tomoike Hiroyuki Yokoyama Yoko Sumita Sotaro Hanai Akiko Kada Tomonori Okamura Junichi Yoshikawa Yoshinori Doi Masatsugu Hori Chuwa Tei on behalf of the Scientific Committee of the JCS

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.79, no.5, pp.1058-1067, 2015-04-24 (Released:2015-04-24)

参考文献数

33

被引用文献数

18 19

---

Background:The geographic distribution of cardiovascular (CV) health-care services has not been assessed systematically.Methods and Results:Data of the Japanese Circulation Society (JCS) annual survey were provided to the JCS working group with the permission of the JCS Scientific Committee. The status of CV practice in 2010 was then assessed in 47 prefectures retrospectively, along with national census and gross domestic product (GDP) data. The surveyed indices included resources (hospitals, beds and cardiologists), burden (number of inpatients), and outcome (CV mortality and autopsy) in each prefecture, which correlated well with respective populations or GDP. Inequality of geographic distribution was evident for pediatrics among the 47 prefectures, according to Lorenz curve, Gini coefficient or the maximum/minimum ratio for each index. According to the Gini coefficients, only the number of inpatients (medical or acute myocardial infarction) and beds for the total number of general hospitals or the hospitals surveyed in the present JCS study were lower than expected with regard to GDP.Conclusions:Geographic disparity of CV resources or burden was larger in pediatrics than in CV medicine or surgery. Improvement of equality in CV practice with regard to appropriateness and quality are the coming challenges for the JCS. (Circ J 2015; 79: 1058–1067)

著者

Hiroshi Kurazumi Ryo Suzuki Bungo Shirasawa Yosuke Miyazaki Hiroki Tateishi Tetsuro Oda Takayuki Okamura Akihito Mikamo Masafumi Yano Kimikazu Hamano

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0949, (Released:2022-02-09)

参考文献数

23

被引用文献数

2

---

Background:Transcatheter aortic valve implantation (TAVI) is increasingly being performed in very elderly patients, although its efficacy and validity remain unclear. This study evaluated real-world TAVI outcomes in Japanese nonagenarians with severe aortic stenosis.Methods and Results:This single-center study retrospectively assessed the early and long-term clinical outcomes of TAVI in nonagenarians (n=35) and in patients aged <90 years (group Y; n=171). There were no in-hospital deaths in either group. The device success rate and early safety were comparable between the 2 groups. The 5-year rates of freedom from cardiac events and deaths were equivalent in both groups. The cumulative survival rate at 5 years was non-significantly lower in nonagenarians (32.6% in nonagenarians vs. 57.5% in patients aged <90 years, P=0.49). There were no differences in the 5-year survival between nonagenarians after TAVI and the sex- and age-matched populations (P=0.18). The Cox regression model revealed that lower hemoglobin levels were associated with all-cause mortality (P=0.02), and age ≥90 years was not associated with all-cause mortality.Conclusions:The early and long-term clinical outcomes of TAVI for selected Japanese nonagenarians were comparable to those in patients aged <90 years. Nonagenarians who underwent TAVI achieved an acceptable prognosis compared to the sex- and age-matched population; thus, TAVI appears to be effective for treating aortic stenosis in Japanese nonagenarians.

著者

Hiroko Deguchi Masataka Ikeda Tomomi Ide Tomonori Tadokoro Soichiro Ikeda Kosuke Okabe Akihito Ishikita Keita Saku Shouji Matsushima Hiroyuki Tsutsui

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.84, no.6, pp.1028-1033, 2020-05-25 (Released:2020-05-25)

参考文献数

20

被引用文献数

9 36

---

Background:Ischemic preconditioning (IPC) is an effective procedure to protect against ischemia/reperfusion (I/R) injury. Hypoxia-inducible factor-1α (Hif-1α) is a key molecule in IPC, and roxadustat (RXD), a first-in-class prolyl hydroxylase domain-containing protein inhibitor, has been recently developed to treat anemia in patients with chronic kidney disease. Thus, we investigated whether RXD pretreatment protects against I/R injury.Methods and Results:RXD pretreatment markedly reduced the infarct size and suppressed plasma creatinine kinase activity in a murine I/R model. Analysis of oxygen metabolism showed that RXD could produce ischemic tolerance by shifting metabolism from aerobic to anaerobic respiration.Conclusions:RXD pretreatment may be a novel strategy against I/R injury.

著者

Toshiki Maeda Hisatomi Arima

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-20-0497, (Released:2020-06-06)

参考文献数

11

被引用文献数

1

著者

Ki-Hun Kim Gi-Byoung Nam Eun-Sun Jin Dong-Kie Kim Sang-Hoon Seol Doo-Il Kim HyungOh Choi Yoo Ri Kim Sung-Hwan Kim Kee-Joon Choi You-Ho Kim

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.77, no.3, pp.619-625, 2013 (Released:2013-02-25)

参考文献数

22

被引用文献数

5 5

---

Background: Prompt diagnosis and management of atrial tachyarrhythmias (ATAs) during catheter ablation of atrial fibrillation (AF) is still challenging. Methods and Results: In 88 patients undergoing catheter ablation of AF, 128 regular ATAs were induced or converted from AF. The coronary sinus activation time (CSAT) around the mitral annulus (MA) was measured as the difference in activation time between the most proximal and distal poles of the coronary sinus (CS) electrodes. Entrainment pacing was performed around the MA, roof area, or cavotricuspid isthmus (CTI) depending on the CSAT result. Mechanisms of tachycardias included macro-reentry around the MA (perimitral atrial flutter [PM-AFL], n=63), roof-dependent AFL (Roof-AFL, n=14), CTI-dependent AFL (CTI-AFL, n=25), and atrial tachycardia (AT, n=26). When the CSAT was ≥45ms, the MA activation sequence was sequential, either proximal to distal or distal to proximal. When the CSAT was <45ms, the MA activation sequence was mainly non-sequential with converging or diverging patterns. CSAT <45ms was highly sensitive in ruling out PM-AFL from other left ATAs. When combined with PPI data from the MA, roof area or CTI, PM-, Roof-, CTI-AFL and AT was successfully differentiated with a high predictive accuracy. Conclusions: A diagnostic algorithm combining CSAT and entrainment pacing is helpful to assess the mechanism of ATAs during catheter ablation of AF.  (Circ J 2013; 77: 619–625)

著者

Haruka Shida Chika Nishiyama Satoe Okabayashi Yosuke Yamamoto Tomonari Shimamoto Takashi Kawamura Tetsuya Sakamoto Taku Iwami

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0341, (Released:2021-11-10)

参考文献数

29

被引用文献数

8

---

Background:Although bystanders’ performance is important to improve outcomes of patients after cardiac arrests, few studies have investigated the barriers of bystanders, including those who could not perform cardiopulmonary resuscitation or any other rescue actions in emergency situations. This study aimed to assess the relationship between the psychological barriers of laypersons who encountered emergency situations and their rescue actions.Methods and Results:A questionnaire survey was conducted and this included laypersons who had encountered emergency situations during the last 5 years. Six questions were about the psychological barriers and 8 questions were about the laypersons’ rescue actions. The primary outcome was any rescue actions performed by laypersons in an actual emergency situation. Overall, 7,827 (92.8%) of 8,430 laypersons responded; of them, 1,361 (16.1%) had encountered emergency situations during the last 5 years, and 1,220 (14.5%) were eligible for inclusion in the analyses. Of the 6 psychological barriers, “fear of approaching a collapsed person” (adjusted odds ratio [AOR] 0.50; 95% confidence interval [95% CI] 0.32–0.79) and “difficulties in judging whether to perform any rescue action” (AOR 0.63; 95% CI 0.40–0.99) were significantly associated with performing any rescue actions.Conclusions:The fear of approaching a collapsed person and difficulties in judging whether to take any actions were identified as the psychological barriers in performing any rescue actions by laypersons who encountered emergency situations.

著者

Yuki Matsumoto Sho Torii Yoshihiro Morino

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0984, (Released:2022-01-06)

参考文献数

1

被引用文献数

1

著者

Yoshihisa Nakano Shiro Adachi

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0981, (Released:2021-12-21)

参考文献数

10

著者

Hiroaki Yokoyama Hirofumi Tomita Satoshi Honda Kensaku Nishihira Sunao Kojima Misa Takegami Yasuhide Asaumi Jun Yamashita Mike Saji Masami Kosuge Jun Takahashi Yasuhiko Sakata Morimasa Takayama Tetsuya Sumiyoshi Hisao Ogawa Kazuo Kimura Satoshi Yasuda on behalf of the JAMIR Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0705, (Released:2021-11-20)

参考文献数

33

被引用文献数

7

---

Background:Acute myocardial infarction (AMI) patients with low body mass index (BMI) exhibit worse clinical outcomes than obese patients; however, to our knowledge, no prospective, nationwide study has assessed the effect of BMI on the clinical outcomes of AMI patients.Methods and Results:In this multi-center, prospective, nationwide Japanese trial, 2,373 AMI patients who underwent emergent percutaneous coronary intervention within 12 h of onset from the Japanese AMI Registry (JAMIR) were identified. Patients were divided into the following 4 groups based on their BMI at admission: Q1 group (BMI <18.5 kg/m2, n=133), Q2 group (18.5≤BMI<25.0 kg/m2, n=1,424), Q3 group (25.0≤BMI<30.0 kg/m2, n=672), and Q4 group (30.0 kg/m2≤BMI, n=144). The primary endpoint was all-cause death, and the secondary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. The median follow-up period was 358 days. Q1 patients were older and had lower prevalence of coronary risk factors. Q1 patients also had higher all-cause mortality and higher incidence of secondary endpoints than normal-weight or obese AMI patients. Multivariate analysis showed that low BMI (Q1 group) was an independent predictor for primary endpoint.Conclusions:AMI patients with low BMI had fewer coronary risk factors but worse clinical outcomes than normal-weight or obese patients.

著者

Matthew Sibbald Natalia Pinilla-Echeverri Mognee Alameer Jorge Chavarria Gustavo Dutra Tej Sheth

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.85, no.11, pp.2053-2062, 2021-10-25 (Released:2021-10-25)

参考文献数

66

被引用文献数

2

---

Background:Optical coherence tomographic (OCT) imaging has enabled identification of lipid, with increasing interest in how it may affect coronary interventions and clinical outcomes. This review summarizes the available evidence around OCT identification of lipid and its effect on interventions, clinical events, and the natural history of coronary disease.Methods and Results:We conducted a scoping review using the Medline, HealthStar, and Embase databases for articles published between 1996 and 2021. We screened 1,194 articles and identified 51 for inclusion in this study, summarizing the key findings. The literature supports a common OCT definition of lipid as low-signal regions with diffuse borders, validated against histology and other imaging modalities with acceptable intra- and inter-rater reliability. There is evidence that OCT-identified lipid at the site of stent implantation increases the risk of edge dissection, incomplete stent apposition, in-stent tissue protrusion, decreased coronary flow after stenting, side branch occlusion, and post-procedural cardiac biomarker increases. In mostly retrospective studies, lipid indices measured at non-stented sites are associated with plaque progression and the development of recurrent ischemic events.Conclusions:There is extensive literature supporting the ability of OCT to identify lipid and demonstrating a substantial impact of lipid on percutaneous coronary intervention outcomes. Future work to prospectively evaluate the effect of the characteristics of lipid-rich plaques on long-term clinical outcomes is needed.

著者

Isamu Mizote Daisuke Nakamura

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0924, (Released:2021-12-04)

参考文献数

9

被引用文献数

1

著者

Norimichi Koitabashi

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0881, (Released:2021-11-13)

参考文献数

14

著者

Géraud Souteyrand Mathieu Valladier Nicolas Amabile François Derimay Brahim Harbaoui Pierre Leddet Pierre Barnay Guilhem Malcles Aurelien Mulliez Colin Berry Romain Eschalier Nicolas Combaret Pascal Motreff

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.82, no.3, pp.783-790, 2018-02-23 (Released:2018-02-23)

参考文献数

14

被引用文献数

3 10

---

Background:Spontaneous reanalyzed coronary thrombus (SRCT) has been reported in autopsy series, but little is known about SRCT, and it is potentially under-diagnosed in clinical practice.Methods and Results:SRCT identified on OCT were included in a French multicenter series, the Lotus Root French Registry. A total of 34 SRCT were identified on OCT in 33 patients (23 male; median age, 56 years; IQR, 52–65 years); 23/33 patients (70%) presented with angina pectoris and/or dyspnea. Three angiographic aspects were distinguished retrospectively: braided, pseudo-dissected, and hazy. Stenosis severity on quantitative coronary analysis varied between 11% and 100% (median, 45%), whereas the reduction in lumen area on OCT varied between 20% and 92% (median, 68%). A typical “lotus root” aspect was confirmed on OCT, consisting of multiple circular concave-edged channels of varying size, numbering between 3 and 12 depending on the slice, separated by smooth-edged septa of high luminosity without posterior attenuation. OCT also served to guide treatment, with stenting in 91% of cases. During the 17-month follow-up 91% of patients had excellent evolution. One death and 3 ACS events occurred.Conclusions:In this large SRCT cohort, angiography had limited diagnostic value whereas OCT could be used to define disease characteristics and guide treatment of lesions inducing angina pectoris and/or silent myocardial ischemia. OCT-guided management was associated with good prognosis.

著者

Yuichi Sawayama Takashi Yamamoto Yukinori Tomita Kohei Asada Noriaki Yagi Megumi Fukuyama Akashi Miyamoto Hiroshi Sakai Tomoya Ozawa Tetsuichiro Isono Daiki Hira Tomohiro Terada Minoru Horie Yoshihisa Nakagawa

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.84, no.9, pp.1575-1581, 2020-08-25 (Released:2020-08-25)

参考文献数

18

被引用文献数

5 13

---

Background:The association between cytochrome P450 (CYP) 2C19 genotypes and adverse events in patients treated with clopidogrel or prasugrel after percutaneous coronary intervention (PCI) in the Japanese population is unclear.Methods and Results:This study consisted of 1,580 patients whoseCYP2C19genotypes were assessed at Shiga University of Medical Science Hospital, and 193 clopidogrel-treated and 217 prasugrel-treated patients who were followed more than 1 year after receiving PCI were analyzed. Among 1,580 patients, the prevalence of normal, intermediate, and poor metabolizers was 32%, 49%, and 17%, respectively. Overall incidence of the primary outcome, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, ischemic stroke, or major bleeding was not significantly different between the clopidogrel and prasugrel groups (adjusted hazard ratio [HR] 1.98, 95% confidence interval [CI] 0.85–4.61, P=0.12). Among patients with theCYP2C19loss-of-function (LOF) allele, however, the incidence of the primary outcome was significantly higher in the clopidogrel group (adjusted HR 3.19, 95% CI 1.10–9.24, P=0.03), whereas no difference was observed among patients without theCYP2C19LOF allele (adjusted HR 0.67, 95% CI 0.14–3.26, P=0.62).Conclusions:Among patients with theCYP2C19LOF allele, the use of clopidogrel was significantly associated with increased adverse events. Thus, further investigation is needed to establish the practical use ofCYP2C19genotyping.

著者

Ryo Nakamaru Hironori Nakagami Hiromi Rakugi Ryuichi Morishita

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-20-0703, (Released:2020-09-08)

参考文献数

56

被引用文献数

6

---

Vaccines are well-known therapies for infectious disease and cancer; however, recently, we and others have developed vaccines for other chronic diseases, such as hypertension, diabetes and dyslipidemia. Although we have many treatment options for hypertension, including angiotensin II type 1 receptor blockers, calcium-channel blockers, and diuretics, a substantial portion of the hypertensive population has uncontrolled blood pressure due to poor medication adherence. When these vaccines are established in the future as therapeutic options for chronic diseases, their administration regimen, such as several times per year, will replace daily medication use. Thus, therapeutic vaccines might be a novel option to control the progression of cardiovascular diseases. Importantly, regarding the development of vaccines against self-antigens (i.e., angiotensin II), the vaccine should efficiently induce a blocking antibody response against the self-antigen without provoking cytotoxic T cells. Therefore, to address the safety and efficiency of therapeutic vaccines, we have developed an original B-cell vaccine to induce antibody production and used carrier proteins, which include exogenous T-cell epitopes through the major histocompatibility complex. In this review, we will introduce the challenges in developing therapeutic vaccines for chronic diseases and describe the therapeutic potential for cardiovascular diseases.

著者

Takeshi Wada Mihoko Hagiwara-Nagasawa Ryuichi Kambayashi Ai Goto Koki Chiba Yoshio Nunoi Hiroko Izumi-Nakaseko Tadashi Koga Akio Matsumoto Yuji Nakazato Keith G. Lurie Atsushi Sugiyama

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.85, no.10, pp.1885-1891, 2021-09-24 (Released:2021-09-24)

参考文献数

29

被引用文献数

1

---

Background:Effects of rapid electrical defibrillation and β-blockade on coronary ischemia/reperfusion-induced ventricular fibrillation (VF) during cardiopulmonary resuscitation (CPR) remain unknown.Methods and Results:After induction of VF by 30 min of ischemia followed by reperfusion, animals were treated with defibrillation alone (Group A, n=13), 2 min of open-chest cardiac massage followed by defibrillation (Group B, n=11), or the same therapy to Group B with propranolol (1 mg/kg, i.v.) treatment before ischemia/reperfusion (Group C, n=11). If return of spontaneous circulation (ROSC) was not attained, each therapy was repeated ≤3 times (Set-1). When ROSC was not obtained within Set-1, cardiac massage was applied to all animals followed by defibrillation, which was repeated ≤3 times (Set-2). ROSC after Set-1 was 8% in Group A, 82% in Group B and 82% in Group C, whereas that after Set-2 was 62% in Group A, 100% in Group B and 82% in Group C. Each animal with ROSC in Groups A (n=8) and B (n=11) showed sinus rhythm, whereas those in Group C (n=9) had sinus rhythm (n=5), atrial fibrillation (n=1), accelerated idioventricular rhythm (n=2) and atrioventricular block (n=1). Post ROSC heart rate and mean arterial pressure were significantly lower in Group C.Conclusions:Cardiac massage increased the likelihood of ROSC vs. rapid defibrillation, but β-blocker pretreatment may worsen hemodynamics and electrical stability after ROSC.

著者

Hiroyuki Miura Chiaki Yokota

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-0769, (Released:2021-10-08)

参考文献数

15

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.