Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial
| Autor: | Raymond R Townsend, Felix Mahfoud, David E Kandzari, Kazuomi Kario, Stuart Pocock, Michael A Weber, Sebastian Ewen, Konstantinos Tsioufis, Dimitrios Tousoulis, Andrew S P Sharp, Anthony F Watkinson, Roland E Schmieder, Axel Schmid, James W Choi, Cara East, Anthony Walton, Ingrid Hopper, Debbie L Cohen, Robert Wilensky, David P Lee, Adrian Ma, Chandan M Devireddy, Janice P Lea, Philipp C Lurz, Karl Fengler, Justin Davies, Neil Chapman, Sidney A Cohen, Vanessa DeBruin, Martin Fahy, Denise E Jones, Martin Rothman, Michael Böhm, Jiro Aoki, Bryan Batson, George Dangas, Shukri David, David Kandzari, Manesh Patel, Kiritkumar Patel, Jasvindar Singh, Thomas Weber, Joachim Weil, Thomas Zeller, Khaled Ziada, Kengo Tanabe, Robert Wilkins, Johanna Contreras, Susan Steigerwalt, Denise Reedus, Satoshi Hoshide, Laura Svetkey, Anjani Rao, Angela Brown, Markus Suppan, Tolga Agdirlioglu, Elias Noory, Craig Chasen |
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| Rok vydání: | 2017 |
| Předmět: |
Denervation
education.field_of_study medicine.medical_specialty Ambulatory blood pressure business.industry Population General Medicine 030204 cardiovascular system & hematology Surgery law.invention 03 medical and health sciences 0302 clinical medicine Blood pressure Randomized controlled trial law Anesthesia Ambulatory Severity of illness Clinical endpoint Medicine 030212 general & internal medicine business education |
| Zdroj: | The Lancet. 390:2160-2170 |
| ISSN: | 0140-6736 |
| DOI: | 10.1016/s0140-6736(17)32281-x |
| Popis: | Summary Background Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. Methods SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749. Findings Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP −5·5 mm Hg (95% CI −9·1 to −2·0; p=0·0031), 24-h DBP −4·8 mm Hg (−7·0 to −2·6; p Interpretation Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation. Funding Medtronic. |
| Databáze: | OpenAIRE |
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