著者

Eiji Karashima Masahiko Fujihara

出版者

JAPANESE SOCIETY OF BIORHEOLOGY

雑誌

Journal of Biorheology (ISSN:18670466)

巻号頁・発行日

vol.36, no.1, pp.3-11, 2022 (Released:2022-07-29)

参考文献数

58

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Peripheral artery disease (PAD) is an obstructive arterial disease of the lower extremities. Due to the aging society and improved diagnostic techniques, the number of patients identified with PAD is increasing. Endovascular treatment (EVT) is a widely accepted interventional management method for diseased lower extremity arteries. Anatomically, the arteries of the lower extremities are divided into three segments: aortoiliac, femoropopliteal, and below-the-knee. The strategies of EVT recommended in the relevant guidelines are different for each segment. During the past 20 years, the indications and strategies of EVT have been evolving owing to the development of devices and improvement of clinical outcomes of EVT. Although it might be challenging to catch up with the evolving EVT strategies, we should develop an optimal EVT strategy for each PAD patient, considering that patient and lesion characteristics would also affect clinical outcomes. In this review, we describe the current knowledge of EVT strategies for each segment. We selected the EVT strategies that are currently performed for a majority of symptomatic PAD patients.

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

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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.