Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.
Division of Cardiology, Department of Cardiovascular Diseases, Cliniques Universitaires Saint-Luc and Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
JACC Cardiovasc Interv. 2020 Feb 24;13(4):471-484. doi: 10.1016/j.jcin.2019.10.048.
The aim of this multicenter, open-label trial was to evaluate the safety and efficacy of alcohol-mediated renal denervation using a novel catheter system (the Peregrine System Infusion Catheter) for the infusion of dehydrated alcohol as a neurolytic agent into the renal periarterial space.
The number of hypertensive patients with uncontrolled blood pressure (BP) remains unacceptably low. The renal sympathetic nervous system has been identified as an attractive therapeutic target.
Forty-five patients with uncontrolled hypertension on ≥3 antihypertensive medications underwent bilateral renal denervation using the Peregrine Catheter with 0.6 ml alcohol infused per renal artery.
All patients were treated as intended. Mean 24-h ambulatory BP reduction at 6 months versus baseline was -11 mm Hg (95% confidence interval [CI]: -15 to -7 mm Hg) for systolic BP and -7 mm Hg (95% CI: -9 to -4 mm Hg) for diastolic BP (p < 0.001 for both). Office systolic BP was reduced by -18/-10 mm Hg (95% CI: -25 to -12/-13 to -6 mm Hg) at 6 months. Antihypertensive medications were reduced in 23% and increased in 5% of patients at 6 months. Adherence to the antihypertensive regimen remained stable over time. The primary safety endpoint, defined as the absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within 1 month, was met in 96% of patients (95% CI: 85% to 99%). Two patients had major adverse events of periprocedural access-site pseudoaneurysms, with major bleeding in one. There were no deaths or instances of myocardial infarction, stroke, transient ischemic attack, or renal artery stenosis. Transient microleaks were noted in 42% and 49% of the left and right main renal arteries, respectively. There were 2 cases of minor vessel dissection that resolved without treatment.
Primary results from this trial suggest that alcohol-mediated renal denervation using the Peregrine Catheter safely reduces blood pressure and as such may represent a novel approach for the treatment of hypertension.
本多中心、开放标签试验的目的是评估使用新型导管系统（Peregrine 系统输注导管）经肾动脉周围间隙注入脱水酒精作为神经溶解剂进行酒精介导的肾去神经支配的安全性和有效性。
血压（BP）控制不佳的高血压患者数量仍然高得令人无法接受。肾交感神经系统已被确定为一个有吸引力的治疗靶点。
45 名接受≥3 种降压药物治疗的未控制高血压患者接受 Peregrine 导管双侧肾去神经支配治疗，每根肾动脉注入 0.6ml 酒精。
所有患者均按计划接受治疗。与基线相比，6 个月时 24 小时动态血压监测的平均收缩压下降-11mmHg（95%置信区间：-15 至-7mmHg），舒张压下降-7mmHg（95%置信区间：-9 至-4mmHg）（均<0.001）。6 个月时诊室收缩压下降-18/-10mmHg（95%置信区间：-25 至-12/-13 至-6mmHg）。6 个月时，23%的患者减少了降压药物，5%的患者增加了降压药物。抗高血压治疗方案的依从性随时间保持稳定。主要安全性终点定义为 1 个月内无围手术期大血管并发症、大出血、急性肾损伤或死亡，96%的患者达到该终点（95%置信区间：85%至 99%）。两名患者发生围手术期入路部位假性动脉瘤的主要不良事件，其中 1 例发生大出血。无死亡或心肌梗死、卒中和短暂性脑缺血发作或肾动脉狭窄。左、右主肾动脉分别有 42%和 49%出现短暂性微漏，2 例小血管夹层无需治疗即可缓解。
本试验的初步结果表明，使用 Peregrine 导管进行酒精介导的肾去神经支配可安全降低血压，因此可能代表治疗高血压的一种新方法。
