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 53

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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 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

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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

Hitoshi Matsuo Tomohiro Kawasaki Tetsuya Amano Yoshiaki Kawase Yoshihiro Sobue Takeshi Kondo Yoshihiro Morino Shunichi Yoda Tomohiro Sakamoto Hiroshi Ito Junya Shite Hiromasa Otake Nobuhiro Tanaka Mitsuyasu Terashima Kazushige Kadota Manesh R. Patel Koen Nieman Campbell Rogers Bjarne L. Norgaard Jeroen J. Bax Kavitha M. Chinnaiyan Daniel S. Berman Timothy A. Fairbairn Lynne M. Hurwitz Koweek Jonathon Leipsic Takashi Akasaka

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

vol.2, no.7, pp.364-371, 2020-07-10 (Released:2020-07-10)

参考文献数

9

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Background:Coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFRCT) is an established tool for identifying lesion-specific ischemia that is now approved for use by the Japanese insurance system. However, current clinical reimbursement is strictly limited to institutions with designated appropriate use criteria (AUC). This study assessed differences in physicians’ behavior (e.g., use and interpretation of FFRCT, final management) according to Japanese AUC and non-AUC site designation.Methods and Results:Of 5,083 patients in the ADVANCE Registry, 1,829 from Japan were enrolled in this study. Physicians’ behavior after interrogating CCTA and FFRCTwas analyzed separately according to AUC and non-AUC site designation. Compared with AUC sites, patients referred for FFRCTfrom non-AUC sites had a higher rate of negative FFRCT, less severe anatomic stenosis, and a slightly lower rate of management plan reclassification (51.2% vs. 61.3%), with near-identical utility in both groups. Actual care corresponded equally well to post-FFRCTplans in both groups. The likelihood of revascularization for positive or negative FFRCTwas similar between the 2 groups. Importantly, AUC and non-AUC sites were equally unlikely to revascularize patients with negative FFRCTand stenosis >50% or patients with positive FFRCTand stenosis <50%.Conclusions:Compared with AUC sites, non-AUC sites had lower disease burden and reclassification of management plans, but nearly identical clinical integration. Actual care corresponded equally well to post-FFRCTrecommendations at both sites.

著者

Taichi Okonogi Tomohiro Kawasaki

出版者

日本循環器学会

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-16-1183, (Released:2017-08-11)

参考文献数

5