著者
Takayuki Ishihara Isamu Mizote Daisuke Nakamura Naotaka Okamoto Tatsuya Shiraki Naoki Itaya Takuya Tsujimura Mitsuyoshi Takahara Takaharu Nakayoshi Osamu Iida Yosuke Hata Masami Nishino Takafumi Ueno Daisaku Nakatani Shungo Hikoso Shinsuke Nanto Toshiaki Mano Yasushi Sakata The COLLABORATION Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-22-0098, (Released:2022-06-04)
参考文献数
31
被引用文献数
2

Background: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 μm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99).Conclusions: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.
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.
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
8

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 73

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.