著者
Takashi Muramatsu Shinichiro Masuda Nozomi Kotoku Ken Kozuma Hideyuki Kawashima Yuki Ishibashi Gaku Nakazawa Kuniaki Takahashi Takayuki Okamura Yosuke Miyazaki Hiroki Tateishi Masato Nakamura Norihiro Kogame Taku Asano Shimpei Nakatani Yoshihiro Morino Yuki Katagiri Kai Ninomiya Shigetaka Kageyama Hiroshi Takahashi Scot Garg Shengxian Tu Kengo Tanabe Yukio Ozaki Patrick W. Serruys Yoshinobu Onuma
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0051, (Released:2023-03-11)
参考文献数
36
被引用文献数
6

Background: P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).Methods and Results: ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis.Conclusions: This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This “aspirin-free” strategy may be a safe alternative to traditional DAPT following PCI.
著者
Mitsuaki Sawano Shun Kohsaka Hideki Ishii Yohei Numasawa Kyohei Yamaji Taku Inohara Tetsuya Amano Yuji Ikari Masato Nakamura
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-21-0098, (Released:2021-06-24)
参考文献数
38
被引用文献数
24

Background:Acute coronary syndrome (ACS) hospital survivors experience a wide array of late adverse cardiac events, despite considerable advances in the quality of care. We investigated 30-day and 1-year outcomes of ACS hospital survivors using a Japanese nationwide cohort.Methods and Results:We studied 20,042 ACS patients who underwent percutaneous coronary intervention (PCI) in 2017: 10,242 (51%) with ST-elevation myocardial infarction (STEMI), 3,027 (15%) with non-ST-elevation myocardial infarction (NSTEMI), and 6,773 (34%) with unstable angina (UA). The mean (±SD) age was 69.6±12.4 years, 77% of the patients were men, and 20% had a previous history of PCI. The overall 30-day all-cause, cardiac, and non-cardiac mortality rates were 3.0%, 2.4%, and 0.6%, respectively. The overall 1-year incidence of all-cause, cardiac, and non-cardiac death was 7.1%, 4.2%, and 2.8%, respectively. Compared with UA patients, STEMI patients had a higher risk of all fatal events, non-fatal ischemic stroke, and acute heart failure, and NSTEMI patients had a higher risk of heart failure.Conclusions:The results from our ACS hospital survivor PCI database suggest the need to improve care for the acute myocardial infarction population to lessen the burden of 30-day mortality due to ACS, heart failure, and sudden cardiac death, as well as 1-year ischemic stroke and heart failure events.
著者
Tatsunori Noto Go Hashimoto Takahito Takagi Toru Awaya Tadashi Araki Masanori Shiba Raisuke Iijima Hidehiko Hara Masao Moroi Masato Nakamura Kaoru Sugi
出版者
一般社団法人 日本内科学会
雑誌
Internal Medicine (ISSN:09182918)
巻号頁・発行日
pp.7937-16, (Released:2017-09-06)
参考文献数
14
被引用文献数
19

A 29-year-old woman who worked as a KAATSU (a type of body exercise that involves blood flow restriction) instructor visited our emergency room with a chief complaint of swelling and left upper limb pain. Chest computed tomography (CT) showed non-uniform contrast images corresponding to the site from the left axillary vein to the left subclavian vein; vascular ultrasonography of the upper limb revealed a thrombotic obstruction at the same site, leading to a diagnosis of Paget-Schroetter syndrome (PSS). We herein report our experience with a case of PSS derived from thoracic outlet syndrome (TOS), in a patient who was a KAATSU instructor.
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
Masato Nakamura Mamoru Nozaki Yuji Iwata Nozomu Koizumi Yasushi Sato
出版者
Japanese Society for Plant Biotechnology
雑誌
Plant Biotechnology (ISSN:13424580)
巻号頁・発行日
vol.39, no.2, pp.129-138, 2022-06-25 (Released:2022-06-25)
参考文献数
48
被引用文献数
2

Endoplasmic reticulum (ER) stress activates unfolded protein responses (UPRs), such as promoting protein folding under the control of specific gene expression. Our previous study showed that ER stress induced by ER stress inducers such as tunicamycin (Tm), an inhibitor of N-linked glycan synthesis, causes ectopic lignin deposition in Arabidopsis roots, but the relationship between UPR and ectopic lignin deposition remains unclear. The receptor-like kinase THESEUS1 (THE1) has been shown to sense cell wall damage (CWD) induced in Arabidopsis by cellulose synthase inhibitors such as isoxaben (ISO) and to activate ectopic lignin deposition. In this study, we assessed the involvement of THE1 in ectopic lignin deposition caused by the ER stress inducer Tm. The loss-of-function mutation of THE1, the1-3, suppressed Tm-induced root growth inhibition and ectopic lignin deposition, revealing that THE1 is involved in root growth defects and ectopic lignin deposition caused by ER stress. Similarly, ISO treatment induced ectopic lignin deposition as well as the expression of the UPR marker genes binding protein 3 (BiP3) and ER-localized DnaJ 3b (ERdj3b). Conversely, in the the1-3 mutant, ISO-induced ectopic lignin deposition and the expression of BiP3 and ERdj3b were suppressed. These results showed that THE1 is involved in not only root growth inhibition and ectopic lignin deposition caused by ER stress but also CWD-induced UPR.
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
Takanari Kitazono Masahiro Kamouchi Yuji Matsumaru Masato Nakamura Kazuo Umemura Hajime Matsuo Nobuyuki Koyama Junko Tsutsumi Kazumi Kimura
出版者
Japan Atherosclerosis Society
雑誌
Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日
pp.63473, (Released:2022-05-21)
参考文献数
12
被引用文献数
8

Aim: To examine the efficacy and safety of prasugrel vs clopidogrel in thrombotic stroke patients at risk of ischemic stroke. Methods: This multicenter, active-controlled, randomized, double-blind, double-dummy, parallel group study enrolled thrombotic stroke patients aged ≥ 50 years at risk of ischemic stroke. Patients received prasugrel (3.75 mg/day) or clopidogrel (75 or 50 mg/day) for 24–48 weeks; other antiplatelet drugs were prohibited. The primary efficacy endpoint was the composite incidence of ischemic stroke, myocardial infarction (MI), and death from other vascular causes from the start to 1 day after treatment completion or discontinuation. Secondary efficacy endpoints included the incidences of ischemic stroke, MI, death from other vascular causes, ischemic stroke and transient ischemic attack, and stroke. Safety endpoints included bleeding events and adverse events (AEs). Results: In the prasugrel (N=118) and clopidogrel (N=112; all received 75 mg) groups, the primary efficacy endpoint composite incidence (95% confidence interval) was 6.8% (3.0%–12.9%) and 7.1% (3.1%–13.6%), respectively. The risk ratio (prasugrel/clopidogrel) was 0.949 (0.369–2.443). Secondary efficacy endpoints followed a similar trend. The combined incidences of life-threatening, major, and clinically relevant bleeding were 5.0% and 3.5% in the prasugrel and clopidogrel groups, respectively. The incidences of all bleeding events and AEs were 19.2% and 24.6% and 76.7% and 82.5% in the prasugrel and clopidogrel groups, respectively. No serious AEs were causally related to prasugrel. Conclusions: We observed a risk reduction of 5% with prasugrel vs clopidogrel, indicating comparable efficacy. There were no major safety issues for prasugrel.
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
Masato Nakamura Ken Kozuma Takanari Kitazono Tomoko Iizuka Toru Sekine Kazuhito Shiosakai Isao Usui Seiji Kogure
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-18-0956, (Released:2019-01-24)
参考文献数
19
被引用文献数
10

Background: A unique dose of prasugrel has been approved exclusively for Japanese patients, but real-world data for prasugrel at that dose in patients with ischemic heart disease (IHD) are limited. Therefore, large-scale, real-world data are needed. Methods and Results: A 2-year observational study of Japanese patients with IHD undergoing percutaneous coronary intervention and being treated with prasugrel to evaluate safety and effectiveness. This report is an interim analysis of data from case report forms (CRFs) after 3 months. CRFs were collected from 4,270 patients, 4,157 of whom were eligible for the safety and effectiveness analysis sets (mean age, 68.3 years; male, 76.5%). The median treatment period was 112 days, and 92.3% of patients continued treatment with prasugrel. The incidence of non-coronary artery bypass grafting-related bleeding adverse events (AEs) was 3.1%, of which Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeding accounted for 0.5% and 0.6%, respectively. The most common bleeding AEs were gastrointestinal disorders, which accounted for 43.2% of the sum of “TIMI major and minor bleeding AEs”. The incidence of major adverse cardiovascular events (MACE) was 1.0%, and the cumulative incidence of MACE was 1.4%. The incidence of stent thrombosis was 0.2%. Conclusions: Interim study results indicated that prasugrel was safe and effective during the early phase of treatment in Japanese patients with IHD in real-world clinical settings.
著者
Masato Nakamura Satoru Otsuji Yoshihisa Nakagawa Yuji Oikawa Nobuo Shiode Masatoshi Miyahara Toshihito Furukawa Gaku Nakazawa Hiroyoshi Yokoi on behalf of the PROPEL Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-18-0011, (Released:2018-07-03)
参考文献数
31
被引用文献数
2

Background:The Resolute Integrity coronary drug-eluting stent (DES), the next evolution of the Resolute DES, is designed with thinner stent struts and continuous sinusoidal technology to further enhance performance. This study evaluated the performance of the Resolute Integrity DES compared with the historical performance of Xience V.Methods and Results:We assessed the safety, efficacy, and deliverability of Resolute Integrity compared with the Xience DES, the prespecified historical control, in PROPEL, a large, real-world prospective, single-arm, open-label study. A total of 1,204 subjects were enrolled in PROPEL and treated with the Resolute Integrity DES at 76 sites in Japan. Lesion and procedural success rates were 100% and 99%, respectively. Patients were equally complex in the Resolute Integrity and Xience cohorts. At 1 year in the clinical-only cohort, the primary endpoint target lesion failure was 4.3% (34/800) in the Resolute Integrity cohort compared with 8.5% (97/1,142) in the Xience historical controls (P<0.001 for non-inferiority). Target vessel failure, major adverse cardiac events, target vessel myocardial infarction, and the composite cardiac death and target vessel myocardial infarction were all lower with Resolute Integrity compared with Xience, including in “high risk” patients.Conclusions:In the large, prospective, multicenter PROPEL trial, the performance of the Resolute Integrity DES was non-inferior to that of the benchmark Xience DES used as a historical comparator.
著者
Mariko Harada-Shiba Junya Ako Atsushi Hirayama Masato Nakamura Atsushi Nohara Kayoko Sato Yoshitaka Murakami Ryusuke Koshida Asuka Ozaki Hidenori Arai
出版者
Japan Atherosclerosis Society
雑誌
Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日
vol.29, no.8, pp.1201-1212, 2022-08-01 (Released:2022-08-01)
参考文献数
32
被引用文献数
3 7

Aim: Genetic testing can provide a definitive diagnosis of familial hypercholesterolemia (FH). However, accessibility of genetic testing may be limited in certain countries where it is not considered “standard of care,” including Japan. In addition, mutations responsible for FH cannot be identified in approximately 30% of patients. Methods: EXPLORE-J is a multicenter, prospective, observational study of patients presenting with acute coronary syndrome (ACS). The genetic data were analyzed and adjudicated as pathogenic, indeterminate, or nondetectable pathogenic variant.Results: Of 1,944 patients, 431 underwent genetic screening. Overall, most patients had nonpathogenic variants of LDLR, LDLRAP1, or PCSK9 (n=396, 91.9%). Of the 25 (5.8%) patients with pathogenic variants, variants of the LDLR gene and the PCSK9 gene were seen in 10 and 15 patients, respectively. Indeterminate variants were observed in 10 (2.3%) patients. Of the 431 patients, eight (1.9%) met the criteria for a diagnosis of FH using the Japanese Atherosclerosis Society (JAS) 2017 guidelines. When genetic data were incorporated, 33 (7.7%) patients met the JAS guidelines. No patients with FH pathogenic variants satisfied the JAS clinical criteria for a diagnosis of FH.Conclusions: The results revealed a higher prevalence of genetic mutations of FH among Japanese patients with ACS and a low sensitivity of the FH diagnostic criteria of the JAS 2017 guidelines. These findings highlight the difficulties of FH diagnosis in patients with ACS in the acute phase and suggest the importance of genetic testing and family history.
著者
Shingo Kujime Hidehiko Hara Yoshinari Enomoto Keijiro Nakamura Takashi Yoshitama Mahito Noro Masao Moroi Kaoru Sugi Masato Nakamura
出版者
International Heart Journal Association
雑誌
International Heart Journal (ISSN:13492365)
巻号頁・発行日
vol.60, no.6, pp.1444-1447, 2019-11-30 (Released:2019-11-30)
参考文献数
14
被引用文献数
2

A healthy 73-year-old woman unpredictably developed Takotsubo cardiomyopathy syndrome (TTS) during Holter-electrocardiogram (ECG) recording. Thus, the complete chronological ECG data on the actual onset day of TTS were obtained. Many heart rate variability (HRV) parameters, including the low-frequency components (LF) and the high-frequency components (HF), on the actual onset day and in the healing phase were calculated. The interesting facts on the actual onset day were that the suppression of both LF and HF appeared earlier than the changes of the ECG waveform; and the LF/HF ratio remained within the normal range, although both LF and HF were markedly suppressed. The abnormality on the actual onset day was clear compared with the healing phase. It is noteworthy to obtain the chronological ECG data on the actual onset day of TTS in a healthy patient. The present data are unique in terms of being analyzed on the actual onset day. Although the HRV parameters, including LF and HF, were obviously abnormal, there is some skepticism about using HRV parameters as indices of cardiac autonomic activity. In the present case, it was concluded that the abnormality of cardiac autonomic activity contributed to the onset of TTS. These data are unlikely to ever be replicated, and we hope that this report helps elucidate the TTS mechanism.
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 Munenori Takata Hiroyoshi Yokoi Takafumi Ueno Yuka Suzuki Koji Ikeda Takuhiro Yamaguchi
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-21-0171, (Released:2021-04-29)
参考文献数
30
被引用文献数
2

Background:The effect of treatment with paclitaxel-containing devices (PTXD) on mortality in patients with peripheral artery disease remains controversial.Methods and Results:An independent patient-level meta-analysis of 12 clinical trials (1,389 PTXD patients and 1,192 non-PTXD patients) was conducted. This study included 7 pivotal trials and 5 post-marketing surveillance studies on endovascular treatment for femoropopliteal artery by 6 companies. The primary endpoint was all-cause death, and 5-year cumulative mortality was estimated by a Kaplan-Meier curve. Cox proportional hazard model was used to calculate the hazard ratio (HR) and confidential interval (CI). During the median follow up of 3.0 years, 459 patients died. The cumulative 5-year mortality for the entire cohort was significantly lower in the PTXD than in the non-PTXD group (24.4% vs. 27.4%, respectively; HR, 0.81; 95% CI, 0.67–0.97; P=0.023), but this difference was no longer significant after adjustment for relevant covariates (HR, 1.01; 95% CI, 0.39–2.58; P=0.987). The Cox proportional hazard model revealed that sex, hyperlipidemia, Type 2 diabetes, hemodialysis, Rutherford category, and age above 75 years were significantly associated with 5-year mortality, but treatment with PTXD was not.Conclusions:This large individual meta-analysis of patients with femoropopliteal artery disease found that the use of PTXD does not have a negative effect on 5-year mortality.