重度颈动脉狭窄患者在颈动脉支架置入术前进行远程缺血预处理的安全性和有效性：一项概念验证性随机对照试验
Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial.
作者信息
Zhao Wenbo, Meng Ran, Ma Chun, Hou Baojun, Jiao Liqun, Zhu Fengshui, Wu Weijuan, Shi Jingfei, Duan Yunxia, Zhang Renling, Zhang Jing, Sun Yongxin, Zhang Hongqi, Ling Feng, Wang Yuping, Feng Wuwei, Ding Yuchuan, Ovbiagele Bruce, Ji Xunming
机构信息
From Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China (W.Z., R.M., W.W., J.Z., Y.S., Y.W.); Department of Surgical Intensive Care Unit, Beijing Anzhen Hospital, Capital Medical University, China (C.M.); Department of Intensive Care Unit, Shanxian Central Hospital, Heze, China (B.H.); Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China (L.J., F.Z., H.Z., F.L., X.J.); China-America Joint Institution of Neuroscience, Xuanwu Hospital, Capital Medical University, Beijing, China (J.S., Y.D.); Department of Nuclear Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China (R.Z.); Department of Neurology, Medical University of South Carolina, Charleston (W.F., B.O.); and Department of Neurosurgery, Wayne State University, Detroit, MI (Y.D.).
出版信息
Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.
BACKGROUND
Remote ischemic preconditioning (RIPC) can inhibit recurrent ischemic events effectively in patients with acute or chronic cerebral ischemia. However, it is still unclear whether RIPC can impede ischemic injury after carotid artery stenting (CAS) in patients with severe carotid artery stenosis.
METHODS
Subjects with severe carotid artery stenosis were recruited in this randomized controlled study, and assigned to RIPC, sham, and no intervention (control) groups. All subjects received standard medical therapy. Subjects in the RIPC and sham groups underwent RIPC and sham RIPC twice daily, respectively, for 2 weeks before CAS. Plasma neuron-specific enolase and S-100B were used to evaluate safety, hypersensitive C-reactive protein, and new ischemic diffusion-weighted imaging lesions were used to determine treatment efficacy. The primary outcomes were the presence of ≥1 newly ischemic brain lesions on diffusion-weighted imaging within 48 hours after stenting and clinical events within 6 months after stenting.
RESULTS
We randomly assigned 189 subjects in this study (63 subjects in each group). Both RIPC and sham RIPC procedures were well tolerated and completed with high compliance (98.41% and 95.24%, respectively). Neither plasma neuron-specific enolase levels nor S-100B levels changed significantly before and after treatment. No severe adverse event was attributed to RIPC and sham RIPC procedures. The incidence of new diffusion-weighted imaging lesions in the RIPC group (15.87%) was significantly lower than in the sham group (36.51%; relative risk, 0.44; 96% confidence interval, 0.20-0.91; <0.01) and the control group (41.27%; relative risk, 0.39; 96% confidence interval, 0.21-0.82; <0.01). The volumes of lesions were smaller in the RIPC group than in the control and sham groups (<0.01 each). Ischemic events that occurred after CAS were 1 transient ischemic attack in the RIPC group, 2 strokes in the control group, and 2 strokes and 1 transient ischemic attack in the sham group, but these results were not significantly different among the 3 groups (=0.597).
CONCLUSIONS
RIPC is safe in patients undergoing CAS, which may be able to decrease ischemic brain injury secondary to CAS. However, the mechanisms and effects of RIPC on clinical outcomes in this cohort of patients need further investigation.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01654666.
背景
远程缺血预处理（RIPC）可有效抑制急性或慢性脑缺血患者的复发性缺血事件。然而，RIPC是否能减轻重度颈动脉狭窄患者颈动脉支架置入术（CAS）后的缺血性损伤仍不清楚。
方法
本随机对照研究招募了重度颈动脉狭窄患者，将其分为RIPC组、假手术组和无干预（对照组）。所有受试者均接受标准药物治疗。RIPC组和假手术组的受试者在CAS前每天分别进行2次RIPC和假RIPC，持续2周。采用血浆神经元特异性烯醇化酶和S-100B评估安全性，采用超敏C反应蛋白和新出现的缺血性弥散加权成像病变来确定治疗效果。主要结局为支架置入后48小时内弥散加权成像上≥1个新的缺血性脑病变的出现以及支架置入后6个月内的临床事件。
结果
本研究随机分配了189名受试者（每组63名）。RIPC和假RIPC操作均耐受性良好，依从性高（分别为98.41%和95.24%）。治疗前后血浆神经元特异性烯醇化酶水平和S-100B水平均无明显变化。未发现严重不良事件是由RIPC和假RIPC操作引起的。RIPC组新出现的弥散加权成像病变发生率（15.87%）显著低于假手术组（36.51%；相对风险，0.44；96%置信区间，0.20-0.91；<0.01）和对照组（41.27%；相对风险，0.39；96%置信区间，0.21-0.82；<0.01）。RIPC组病变体积小于对照组和假手术组（每组<0.01）。CAS后发生的缺血事件在RIPC组有1次短暂性脑缺血发作，对照组有2次中风，假手术组有2次中风和1次短暂性脑缺血发作，但这3组之间的结果无显著差异（P = 0.597）。
结论
RIPC对接受CAS的患者是安全的，可能能够减少CAS继发的缺血性脑损伤。然而，RIPC对该队列患者临床结局的机制和影响需要进一步研究。
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