Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial

被引：103

作者：

Kario, Kazuomi ^{[1
]}

Yokoi, Yoshiaki ^{[2
]}

Okamura, Keisuke ^{[3
]}

Fujihara, Masahiko ^{[2
]}

Ogoyama, Yukako ^{[1
]}

Yamamoto, Eiichiro ^{[4
]}

Urata, Hidenori ^{[3
]}

Cho, Jin-Man ^{[5
]}

Kim, Chong-Jin ^{[6
]}

Choi, Seung-Hyuk ^{[7
]}

Shinohara, Keisuke ^{[8
]}

Mukai, Yasushi ^{[9
]}

Ikemoto, Tomokazu ^{[10
]}

Nakamura, Masato ^{[11
]}

Seki, Shuichi ^{[12
]}

Matoba, Satoaki ^{[13
]}

Shibata, Yoshisato ^{[14
]}

Sugawara, Shigeo ^{[15
]}

Yumoto, Kazuhiko ^{[16
]}

Tamura, Kouichi ^{[17
]}

Yoshihara, Fumiki ^{[18
]}

Nakamura, Satoko ^{[19
]}

Kang, Woong Chol ^{[20
]}

Shibasaki, Taro ^{[21
]}

Dote, Keigo ^{[22
]}

Yokoi, Hiroyoshi ^{[23
]}

Matsuo, Akiko ^{[24
]}

Fujita, Hiroshi ^{[25
]}

Takahashi, Toshiyuki ^{[26
]}

Kang, Hyun-Jae ^{[27
,28
]}

Sakata, Yasushi ^{[29
]}

Horie, Kazunori ^{[30
]}

Inoue, Naoto ^{[31
]}

Sasaki, Ken-ichiro ^{[32
]}

Ueno, Takafumi ^{[33
]}

Tomita, Hirofumi ^{[34
]}

Morino, Yoshihiro ^{[35
]}

Nojima, Yuhei ^{[36
]}

Kim, Chan Joon ^{[37
]}

Matsumoto, Tomoaki ^{[38
]}

Kai, Hisashi ^{[39
]}

Nanto, Shinsuke ^{[36
]}

机构：

[1] Jichi Med Univ, Sch Med, Dept Med, Div Cardiovasc Med, Shimotsuke, Tochigi, Japan

[2] Kishiwada Tokushukai Hosp, Dept Cardiol, Osaka, Japan

[3] Fukuoka Univ, Chikushi Hosp, Dept Cardiovasc Dis, Fukuoka, Japan

[4] Kumamoto Univ, Grad Sch Med Sci, Dept Cardiovasc Med, Kumamoto, Japan

[5] KyungHee Univ Hosp Gangdong, Dept Internal Med, Div Cardiol, Seoul, South Korea

[6] CHA Gangnam Med Ctr, Dept Internal Med, Div Cardiol, Seoul, South Korea

[7] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Div Cardiol,Heart Vasc & Stroke Inst,Dept Med, Seoul, South Korea

[8] Kyushu Univ Hosp, Dept Cardiovasc Med, Fukuoka, Japan

[9] Fukuoka Red Cross Hosp, Div Cardiol, Fukuoka, Japan

[10] Kumamoto Red Cross Hosp, Div Cardiol, Kumamoto, Japan

[11] Toho Univ, Ohashi Med Ctr, Div Cardiovasc Med, Tokyo, Japan

[12] Chikamori Hosp, Dept Cardiol, Kochi, Japan

[13] Kyoto Prefectural Univ Med, Grad Sch Med Sci, Dept Cardiovasc Med, Kyoto, Japan

[14] Miyazaki Med Assoc Hosp, Dept Cardiol, Miyazaki, Japan

[15] Nihonkai Gen Hosp, Dept Cardiol, Yamagata, Japan

[16] Yokohama Rosai Hosp, Dept Cardiol, Yokohama, Kanagawa, Japan

[17] Yokohama City Univ, Med Ctr, Dept Med Sci & Cardiorenal Med, Yokohama, Kanagawa, Japan

[18] Natl Cerebral & Cardiovasc Ctr, Div Nephrol & Hypertens, Osaka, Japan

[19] Kansai Univ Welf Sci, Dept Nutr Sci Well Being, Osaka, Japan

[20] Gachon Univ, Coll Med, Gil Med Ctr, Dept Cardiol, Incheon, South Korea

[21] Saitama Sekishinkai Hosp, Dept Cardiol, Saitama, Japan

[22] Hiroshima City Asa Hosp, Dept Cardiol, Hiroshima, Japan

[23] Fukuoka Sanno Hosp, Cardiovasc Ctr, Fukuoka, Japan

[24] Japanese Red Cross Kyoto Daini Hosp, Dept Cardiol, Kyoto, Japan

[25] Kyoto Prefectural Univ Med, North Med Ctr, Dept Cardiol, Kyoto, Japan

[26] Saiseikai Cent Hosp, Dept Cardiol, Tokyo, Japan

[27] Seoul Natl Univ, Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea

[28] Seoul Natl Univ, Univ Coll Med, Seoul, South Korea

[29] Osaka Univ, Grad Sch Med, Dept Cardiovasc Med, Osaka, Japan

[30] Sendai Kousei Hosp, Dept Cardiovasc Med, Sendai, Miyagi, Japan

[31] Tokyo Kamata Hosp, Cardiovasc Ctr, Tokyo, Japan

[32] Kurume Univ, Sch Med, Dept Internal Med, Div Cardiovasc Med, Fukuoka, Japan

[33] Fukuoka Kinen Hosp, Div Cardiol, Fukuoka, Japan

[34] Hirosaki Univ, Grad Sch Med, Dept Cardiol, Aomori, Japan

[35] Iwate Med Univ, Dept Internal Med, Div Cardiol, Morioka, Iwate, Japan

[36] Nishinomiya Municipal Cent Hosp, Dept Cardiovasc Med, Nishinomiya, Hyogo, Japan

[37] Catholic Univ Korea, Coll Med, Uijeongbu St Marys Hosp, Div Cardiol,Dept Internal Med, Seoul, South Korea

[38] Oji Gen Hosp, Dept Cardiol, Tomakomai, Hokkaido, Japan

[39] Kurume Univ, Med Ctr, Dept Cardiol, Fukuoka, Japan

来源：

HYPERTENSION RESEARCH | 2022年 / 45卷 / 02期

关键词：

Ambulatory blood pressure; Hypertension; Renal denervation; Sham procedure; Systolic blood pressure; BLOOD-PRESSURE; ANTIHYPERTENSIVE TREATMENT; UNCONTROLLED HYPERTENSION; SYMPATHETIC DENERVATION; CARDIOVASCULAR-DISEASE; RISK-FACTORS; JAPANESE; HTN; DETERMINANTS; POPULATION;

D O I：

10.1038/s41440-021-00754-7

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure >= 150/90 mmHg and 24-hour ambulatory systolic blood pressure >= 140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (-6.6 mmHg) and sham control (-6.5 mmHg) groups (difference: -0.1, 95% confidence interval -5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: -1.8 mmHg [p = 0.488] and -2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial.

引用

页码：221 / 231

页数：11

共 47 条

[1] Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial [J].

Azizi, Michel ;

Sanghvi, Kintur ;

Saxena, Manish ;

Gosse, Philippe ;

Reilly, John P. ;

Levy, Terry ;

Rump, Lars C. ;

Persu, Alexandre ;

Basile, Jan ;

Bloch, Michael J. ;

Daemen, Joost ;

Lobo, Melvin D. ;

Mahfoud, Felix ;

Schmieder, Roland E. ;

Sharp, Andrew S. P. ;

Weber, Michael A. ;

Sapoval, Marc ;

Fong, Pete ;

Pathak, Atul ;

Lantelme, Pierre ;

Hsi, David ;

Bangalore, Sripal ;

Witkowski, Adam ;

Weil, Joachim ;

Kably, Benjamin ;

Barman, Neil C. ;

Reeve-Stoffer, Helen ;

Coleman, Leslie ;

McClure, Candace K. ;

Kirtane, Ajay J. .

LANCET, 2021, 397 (10293) :2476-2486

[2] Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial [J].

Azizi, Michel ;

Schmieder, Roland E. ;

Mahfoud, Felix ;

Weber, Michael A. ;

Daemen, Joost ;

Lobo, Melvin D. ;

Sharp, Andrew S. P. ;

Bloch, Michael J. ;

Basile, Jan ;

Wang, Yale ;

Saxena, Manish ;

Lurz, Philipp ;

Rader, Florian ;

Sayer, Jeremy ;

Fisher, Naomi D. L. ;

Fouassier, David ;

Barman, Neil C. ;

Reeve-Stoffer, Helen ;

McClure, Candace ;

Kirtane, Ajay J. .

CIRCULATION, 2019, 139 (22) :2542-2553

[3] Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial [J].

Azizi, Michel ;

Schmieder, Roland E. ;

Mahfoud, Felix ;

Weber, Michael A. ;

Daemen, Joost ;

Davies, Justin ;

Basile, Jan ;

Kirtane, Ajay J. ;

Wang, Yale ;

Lobo, Melvin D. ;

Saxena, Manish ;

Feyz, Lida ;

Rader, Florian ;

Lurz, Philipp ;

Sayer, Jeremy ;

Sapoval, Marc ;

Levy, Terry ;

Sanghvi, Kintur ;

Abraham, Josephine ;

Sharp, Andrew S. P. ;

Fisher, Naomi D. L. ;

Bloch, Michael J. ;

Reeve-Stoffer, Helen ;

Coleman, Leslie ;

Mullin, Christopher ;

Mauri, Laura .

LANCET, 2018, 391 (10137) :2335-2345

[4] Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial [J].

Azizi, Michel ;

Pereira, Helena ;

Hamdidouche, Idir ;

Gosse, Philippe ;

Monge, Matthieu ;

Bobrie, Guillaume ;

Delsart, Pascal ;

Mounier-Vehier, Claire ;

Courand, Pierre-Yves ;

Lantelme, Pierre ;

Denolle, Thierry ;

Dourmap-Collas, Caroline ;

Girerd, Xavier ;

Halimi, Jean Michel ;

Zannad, Faiez ;

Ormezzano, Olivier ;

Vaisse, Bernard ;

Herpin, Daniel ;

Ribstein, Jean ;

Chamontin, Bernard ;

Mourad, Jean-Jacques ;

Ferrari, Emile ;

Plouin, Pierre-Francois ;

Jullien, Vincent ;

Sapoval, Marc ;

Chatellier, Gilles .

CIRCULATION, 2016, 134 (12) :847-857

[5] A Controlled Trial of Renal Denervation for Resistant Hypertension [J].

Bhatt, Deepak L. ;

Kandzari, David E. ;

O'Neill, William W. ;

D'Agostino, Ralph ;

Flack, John M. ;

Katzen, Barry T. ;

Leon, Martin B. ;

Liu, Minglei ;

Mauri, Laura ;

Negoita, Manuela ;

Cohen, Sidney A. ;

Oparil, Suzanne ;

Rocha-Singh, Krishna ;

Townsend, Raymond R. ;

Bakris, George L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (15) :1393-1401

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

Bohm, Michael ;

Kario, Kazuomi ;

Kandzari, David E. ;

Mahfoud, Felix ;

Weber, Michael A. ;

Schmieder, Roland E. ;

Tsioufis, Konstantinos ;

Pocock, Stuart ;

Konstantinidis, Dimitris ;

Choi, James W. ;

East, Cara ;

Lee, David P. ;

Ma, Adrian ;

Ewen, Sebastian ;

Cohen, Debbie L. ;

Wilensky, Robert ;

Devireddy, Chandan M. ;

Lea, Janice ;

Schmid, Axel ;

Weil, Joachim ;

Agdirlioglu, Tolga ;

Reedus, Denise ;

Jefferson, Brian K. ;

Reyes, David ;

D'Souza, Richard ;

Sharp, Andrew S. P. ;

Sharif, Faisal ;

Fahy, Martin ;

DeBruin, Vanessa ;

Cohen, Sidney A. ;

Brar, Sandeep ;

Townsend, Raymond R. .

LANCET, 2020, 395 (10234) :1444-1451

[7] Adherence in Hypertension A Review of Prevalence, Risk Factors, Impact, and Management [J].

Burnier, Michel ;

Egan, Brent M. .

CIRCULATION RESEARCH, 2019, 124 (07) :1124-1140

[8] SHATTUCK LECTURE The Hypertension Paradox - More Uncontrolled Disease despite Improved Therapy [J].

Chobanian, Aram V. .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (09) :878-887

[9] Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension [J].

Desch, Steffen ;

Okon, Thomas ;

Heinemann, Diana ;

Kulle, Konrad ;

Roehnert, Karoline ;

Sonnabend, Melanie ;

Petzold, Martin ;

Mueller, Ulrike ;

Schuler, Gerhard ;

Eitel, Ingo ;

Thiele, Holger ;

Lurz, Philipp .

HYPERTENSION, 2015, 65 (06) :1202-1208

[10] Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial [J].

Esler, Murray D. ;

Krum, Henry ;

Sobotka, Paul A. ;

Schlaich, Markus P. ;

Schmieder, Roland E. ;

Boehm, Michael ;

Mahfoud, Felix ;

Sievert, Horst ;

Wunderlich, Nina ;

Rump, Lars Christian ;

Vonend, Oliver ;

Uder, Michael ;

Lobo, Mel ;

Caulfield, Mark ;

Erglis, Andrejs ;

Azizi, Michel ;

Sapoval, Marc ;

Thambar, Suku ;

Persu, Alexandre ;

Renkin, Jean ;

Schunkert, Heribert ;

Weil, Joachim ;

Hoppe, Uta C. ;

Walton, Tony ;

Scheinert, Dierk ;

Binder, Thomas ;

Januszewicz, Andrzej ;

Witkowski, Adam ;

Ruilope, Luis M. ;

Whitbourn, Robert ;

Bruck, Heike ;

Downes, Mark ;

Luescher, Thomas F. ;

Jardine, Alan G. ;

Webster, Mark W. ;

Zeller, Thomas ;

Sadowski, Jerzy ;

Bartus, Krzysztof ;

Straley, Craig A. ;

Barman, Neil C. ;

Lee, David P. ;

Witteles, Ronald M. ;

Bhalla, Vivek ;

Massaro, Joseph M. .

LANCET, 2010, 376 (9756) :1903-1909

← 1 2 3 4 5 →