经导管射频消融去肾交感神经术治疗高血压的对照试验
A controlled trial of renal denervation for resistant hypertension.
机构信息
From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B., L.M.), Boston University School of Public Health (R.D.), and Harvard Clinical Research Institute (R.D., L.M.) - all in Boston; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiology, Henry Ford Hospital (W.W.O.), and Wayne State University and the Detroit Medical Center (J.M.F.) - all in Detroit; Baptist Cardiac and Vascular Institute, Miami (B.T.K.); New York Presbyterian Hospital, Columbia University Medical Center, and Cardiovascular Research Foundation, New York (M.B.L.); Medtronic CardioVascular, Santa Rosa, CA (M.L., M.N., S.A.C.); University of Alabama at Birmingham, Birmingham (S.O.); Prairie Heart Institute, Springfield, IL (K.R.-S.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (S.A.C., R.R.T.); and University of Chicago Medicine, Chicago (G.L.B.).
出版信息
N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
BACKGROUND
Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.
METHODS
We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months.
RESULTS
A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups.
CONCLUSIONS
This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
背景
先前未经盲法评估的研究表明，经导管肾动脉去神经术可降低高血压患者的血压。
方法
我们设计了一项前瞻性、单盲、随机、假手术对照试验。将严重难治性高血压患者按 2:1 的比例随机分为肾动脉去神经术组或假手术组。在随机分组前，患者接受了一种包含至少三种最大耐受剂量药物的稳定降压方案，其中包括利尿剂。主要疗效终点为 6 个月时诊室收缩压的变化；次要疗效终点为 24 小时动态收缩压的平均变化。主要安全性终点为 1 个月时死亡、终末期肾病、导致靶器官损害的栓塞事件、肾血管并发症或高血压危象的复合终点，或 6 个月时肾动脉狭窄超过 70%的新发病变。
结果
共有 535 例患者接受了随机分组。与假手术组相比，去神经术组在 6 个月时收缩压的平均变化为-14.13±23.93mmHg，而假手术组为-11.74±25.94mmHg（两组均为与基线相比的变化，P<0.001），差值为-2.39mmHg（95%置信区间，-6.89 至 2.12；P=0.26，以 5mmHg 为优势边界）。去神经术组 24 小时动态收缩压的变化为-6.75±15.11mmHg，假手术组为-4.79±17.25mmHg，差值为-1.96mmHg（95%置信区间，-4.97 至 1.06；P=0.98，以 2mmHg 为优势边界）。两组之间的安全性无显著差异。
结论
与假手术相比，肾动脉去神经术未能显著降低难治性高血压患者 6 个月时的收缩压。（由美敦力公司资助；SYMPLICITY HTN-3 临床试验.gov 编号，NCT01418261。）
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