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无降压药情况下经导管去肾交感神经术可安全降低血压
2020-03-31 16:56

德国萨尔大学Michael Böhm小组取得一项新突破。他们探讨了无抗高血压药情况下经导管去肾交感神经术的疗效。该项研究成果发表在2020年3月28日出版的《柳叶刀》上。

在先前的研究中,经导管去肾交感神经术可显著降低血压。在一项积极的先导试验之后,Spyral试验旨在评估在不使用降压药的情况下去肾交感神经术的疗效。

2015年6月25日至2019年10月15日,研究组在澳大利亚、奥地利、加拿大、德国、希腊、爱尔兰、日本、英国和美国的44个研究点进行了一项国际性、前瞻性、单盲、假手术对照试验。他们招募了331名高血压患者,其诊室收缩压为150-180 mmHg,将其按1:1随机分组,其中166例接受去肾交感神经术,165例接受假手术。

主要疗效终点是24小时收缩压基线调整后的变化,次要疗效终点是从基线到术后3个月诊室收缩压基线调整后的变化。最终主要和次要疗效终点均达到,两者的优势后验概率均大于0.999。

去肾交感神经术组与假手术组的24小时收缩压治疗差异为-3.9 mmHg,诊室收缩压差异为-6.5 mmHg。在3个月内,未发生与设备相关或与手术相关的重大安全事件。

总之,在不使用降压药的情况下,经导管去肾交感神经术比假手术更能安全地降低血压。

附:英文原文

Title: Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial

Author: Michael Bhm, Kazuomi Kario, David E Kandzari, Felix Mahfoud, Michael A Weber, Roland E Schmieder, Konstantinos Tsioufis, Stuart Pocock, Dimitris Konstantinidis, James W Choi, Cara East, David P Lee, Adrian Ma, Sebastian Ewen, Debbie L Cohen, Robert Wilensky, Chandan M Devireddy, Janice Lea, Axel Schmid, Joachim Weil, Tolga Agdirlioglu, Denise Reedus, Brian K Jefferson, David Reyes, Richard DSouza, Andrew S P Sharp, Faisal Sharif, Martin Fahy, Vanessa DeBruin, Sidney A Cohen, Sandeep Brar, Raymond R Townsend, Ertan Akarca, Suhail Allaqaband, Eirini Andrikou, Jiro Aoki, Ahran Arnold, Herbert Aronow, Masahiko Asami, William Bachinsky, John Barton, Kyle Bass, Bryan Batson, Chris Bell, Barry Bertolet, Yvonne Bewarder, Karl Bihlmaier, Christian Binner, Jason Bloom, Benjamin Blossom, Somjot Brar, Angela Brown, Robert Burke, Martin N Burke, Michael Butler, William Calhoun, James Campbell, Steve Carroll, Neil Chapman, Craig Chasen, Shi-Chi Cheng, Beth Chia, Nishit Choksi, Jordana Cohen, Niall Connolly, Johanna Contreras, Ronan Cusack, George Dangas, Shukri David, Justin Davies, Juliane Dederer, Matthew Denker, Udo Desch, Matthaios Didangelos, Thomas Dienemann, Kyriakos Dimitriadis, Jean-Franois Dorval, John Estess, Sarah Fan, Karl Fengler, Lee Ferguson, Marat Fudim, Valentin Fuster, Fidel Garcia, Santiago Garcia, Alex Garton, Carl Gessler, Magdi Ghali, Bharat Gummadi, Amit Gupta, Antonio Gutierrez, Peggy Hardesty, Phillip Hartung, Walter H Haught, Yonghong Haun, Sara Hays, Wolfgang Helmreich, Douglas Hill, Ingrid Hopper, Yu Horiuchi, Satoshi Hoshide, James Howard, Wanda Ikeda, Fued Jan, Rajiv Jauhar, Desmond Jay, James Johnson, Thomas Johnston, Schuyler Jones, Susanne Jung, Theodoros Kalos, Mihar Kanitkar, Dennis Kannenkeril, Alexandros Kasiakogias

Issue&Volume: 2020-03-28

Abstract: Background

Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.

Methods

In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749.

Findings

From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was 3·9 mm Hg (Bayesian 95% credible interval 6·2 to 1·6) and for office systolic blood pressure the difference was 6·5 mm Hg (9·6 to 3·5). No major device-related or procedural-related safety events occurred up to 3 months.

Interpretation

SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.

DOI: 10.1016/S0140-6736(20)30554-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30554-7/fulltext

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:202.731
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet


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