Miyata Tetsuro, Higashi Yukihito, Shigematsu Hiroshi, Origasa Hideki, Fujita Masatoshi, Matsuo Hiroshi, Naritomi Hiroaki, Matsuda Hiroaki, Nakajima Masahide, Yuki Satoshi, Awano Hideto
1 Sanno Hospital and Sanno Medical Center, International University of Health and Welfare, Tokyo, Japan.
2 Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Angiology. 2019 Jul;70(6):506-514. doi: 10.1177/0003319718814351. Epub 2018 Nov 26.
Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON) is a 2-year, prospective, real-world, registry study conducted in Japan from 2009 to 2013. This post hoc analysis evaluated risk factors for limb ischemia in patients with peripheral arterial disease (PAD) and ankle-brachial index (ABI) <0.90. Vascular events were adjudicated by an Efficacy Endpoint Review Committee. Cox regression identified predictors of limb-specific peripheral vascular events (amputation, development of critical limb ischemia, and acute limb ischemia). Patients (n = 6565) were stratified according to ABI: normal (≥1.0; n = 1300), borderline (0.90 ≤ ABI ≤ 1.0; n = 776), and abnormal (<0.90; n = 4489). Compared to normal ABI, patients with ABI <0.90 had a significantly higher risk of any vascular event, all-cause death, and any limb-specific peripheral vascular event. Risk factors for limb-specific vascular events included history of lower extremity revascularization/amputation (adjusted hazard ratio: 2.18; 95% confidence interval [CI]: 1.49-3.20), chronic kidney disease (2.00; 1.33-3.00), diabetes (1.71; 1.16-2.52), and ABI <0.4 (4.45; 2.62-7.55) or <0.7 (1.78; 1.15-2.76). These findings from a Japanese real-world population confirm the increased vascular risk of patients with PAD and ABI <0.90 and identified risk factors for limb-specific peripheral vascular events.
日本抗血小板治疗的动脉硬化闭塞症患者心血管事件监测（SEASON）是一项于2009年至2013年在日本进行的为期2年的前瞻性、真实世界登记研究。这项事后分析评估了外周动脉疾病（PAD）且踝臂指数（ABI）<0.90患者发生肢体缺血的危险因素。血管事件由疗效终点审查委员会判定。Cox回归确定了肢体特异性外周血管事件（截肢、严重肢体缺血的发生以及急性肢体缺血）的预测因素。患者（n = 6565）根据ABI进行分层：正常（≥1.0；n = 1300）、临界（0.90≤ABI≤1.0；n = 776）和异常（<0.90；n = 4489）。与正常ABI相比，ABI<0.90的患者发生任何血管事件、全因死亡以及任何肢体特异性外周血管事件的风险显著更高。肢体特异性血管事件的危险因素包括下肢血运重建/截肢史（调整后风险比：2.18；95%置信区间[CI]：1.49 - 3.20）、慢性肾脏病（2.00；1.33 - 3.00）、糖尿病（1.71；1.16 - 2.52）以及ABI<0.4（4.45；2.62 - 7.55）或<0.7（1.78；1.15 - 2.76）。来自日本真实世界人群的这些发现证实了PAD且ABI<0.90患者血管风险增加，并确定了肢体特异性外周血管事件的危险因素。
