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在RADIANCE-HTN TRIO研究中,超声肾动脉去神经术对联合治疗抵抗的高血压的36个月疗效持久性

36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO.

作者信息

Bloch Michael J, Kirtane Ajay J, Azizi Michel, Mahfoud Felix, Basile Jan, Daemen Joost, Saxena Manish, Thackeray Lisa, McGuire Maureen, Claude Lisa, Schmieder Roland E

机构信息

Department of Medicine, University of Nevada School of Medicine, Vascular Care, Reno, NV, USA.

Renown Regional Medical Center, Reno, NV, USA.

出版信息

Hypertens Res. 2024 Dec;47(12):3467-3472. doi: 10.1038/s41440-024-01854-w. Epub 2024 Sep 27.

DOI:10.1038/s41440-024-01854-w
PMID:39333663
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11618087/
Abstract

Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by -14.5 ± 26.1/-9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and -8.0 ± 24.5/-5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns.

摘要

在多中心、盲法、随机、假手术对照的RADIANCE-HTN TRIO试验中,与假手术组相比,血管内超声肾去神经支配术(uRDN)在2个月时降低了顽固性高血压患者的血压(BP)。本分析评估了随机接受uRDN治疗患者的长期预后。对三联复方抗高血压药耐药的高血压患者被随机分为uRDN组(n = 69)或假手术组(n = 67)。在2至5个月期间,患者遵循标准化的抗高血压药物(AHM)滴定方案。在6个月时,患者不再设盲,并按照标准治疗接受AHM治疗。在uRDN组中,71%(49/69)的患者完成了36个月的随访。筛查时诊室血压为159/103,服用3.9种AHM。单一片剂复方药物时的基线诊室血压为153/99 mmHg。在36个月时,服用3.7种AHM,诊室血压较筛查时变化了-14.5±26.1/-9.0±14.8 mmHg(两者p均<0.001),较基线变化了-8.0±24.5/-5.0±14.6 mmHg(p = 0.007;p = 0.022)。对于顽固性高血压患者,uRDN的疗效可持续至36个月,且无安全性问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bc/11618087/3581ad46215e/41440_2024_1854_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bc/11618087/2d03b9af1ce3/41440_2024_1854_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bc/11618087/3581ad46215e/41440_2024_1854_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bc/11618087/2d03b9af1ce3/41440_2024_1854_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bc/11618087/3581ad46215e/41440_2024_1854_Fig2_HTML.jpg

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本文引用的文献

1
Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.药物升级治疗 6 个月后血管内超声肾脏去神经术或假手术的患者水平汇总分析:RADIANCE 临床试验项目。
Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.
2
Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials.超声去肾神经术在 RADIANCE II、RADIANCE-HTN SOLO 和 RADIANCE-HTN TRIO 试验的患者水平汇总分析。
JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.
3
Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis.
降压预防心血管疾病和死亡:系统评价和荟萃分析。
Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24.
4
Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data.基于心血管风险的降压治疗:一项个体患者数据分析的荟萃分析。
Lancet. 2014 Aug 16;384(9943):591-598. doi: 10.1016/S0140-6736(14)61212-5.