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

Kazuomi Kario, Yoshiaki Yokoi, Keisuke Okamura, Masahiko Fujihara, Yukako Ogoyama, Eiichiro Yamamoto, Hidenori Urata, Jin-Man Cho, Chong-Jin Kim, Seung-Hyuk Choi, Keisuke Shinohara, Yasushi Mukai, Tomokazu Ikemoto, Masato Nakamura, Shuichi Seki, Satoaki Matoba, Yoshisato Shibata, Shigeo Sugawara, Kazuhiko Yumoto, Kouichi Tamura, Fumiki Yoshihara, Satoko Nakamura, Woong Chol Kang, Taro Shibasaki, Keigo Dote, Hiroyoshi Yokoi, Akiko Matsuo, Hiroshi Fujita, Toshiyuki Takahashi, Hyun-Jae Kang, Yasushi Sakata, Kazunori Horie, Naoto Inoue, Ken-Ichiro Sasaki, Takafumi Ueno, Hirofumi Tomita, Yoshihiro Morino, Yuhei Nojima, Chan Joon Kim, Tomoaki Matsumoto, Hisashi Kai, Shinsuke Nanto

Journal: Hypertension research : official journal of the Japanese Society of Hypertension 2022;45(2):221-231

PMID: 34654905

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Abstract

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. CLINICAL TRIAL REGISTRATION: NCT02918305 ( http://www.clinicaltrials.gov ).

Address: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan. [email protected].; Department of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan.; Department of Cardiovascular Diseases, Fukuoka University Chikushi Hospital, Fukuoka, Japan.; Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.; Department of Cardiovascular Medicine, Kumamoto University Graduate School of Medical Science, Kumamoto, Japan.; Division of Cardiology, Department of Internal Medicine, KyungHee University Hospital at Gangdong, Seoul, South Korea.; Division of Cardiology, Department of Internal Medicine, CHA Gangnam Medical Center, Seoul, South Korea.; Division of Cardiology Heart Vascular and Stroke Institute, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.; Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan.; Division of Cardiology, Fukuoka Red Cross Hospital, Fukuoka, Japan.; Division of Cardiology, Kumamoto Red Cross Hospital, Kumamoto, Japan.; Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.; Department of Cardiology, Chikamori Hospital, Kochi, Japan.; Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.; Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan.; Department of Cardiology, Nihonkai General Hospital, Yamagata, Japan.; Department of Cardiology, Yokohama Rosai Hospital, Kanagawa, Japan.; Department of Medical Science and Cardiorenal Medicine, Yokohama City University Medical Center, Kanagawa, Japan.; Division of Nephrology and Hypertension, National Cerebral and Cardiovascular Center, Osaka, Japan.; Department of Nutritional Science for Well-being, Kansai University of Welfare Sciences, Osaka, Japan.; Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.; Department of Cardiology, Saitama Sekishinkai Hospital, Saitama, Japan.; Department of Cardiology, Hiroshima City Asa Hospital, Hiroshima, Japan.; Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka, Japan.; Department of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.; Department of Cardiology, North Medical Center, Kyoto Prefectural University of Medicine, Kyoto, Japan.; Department of Cardiology, Saiseikai Central Hospital, Tokyo, Japan.; Department of Internal Medicine, Seoul National University Hospital and University College of Medicine, Seoul National University, Seoul, South Korea.; Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.; Department of Cardiovascular Medicine, Sendai Kousei Hospital, Miyagi, Japan.; Cardiovascular Center, Tokyo Kamata Hospital, Tokyo, Japan.; Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.; Division of Cardiology, Fukuoka Kinen Hospital, Fukuoka, Japan.; Department of Cardiology, Hirosaki University Graduate School of Medicine, Aomori, Japan.; Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan.; Department of Cardiovascular Medicine, Nishinomiya Municipal Central Hospital, Hyogo, Japan.; Division of Cardiology, Department of Internal Medicine, Uijeongbu St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.; Department of Cardiology, Oji General Hospital, Hokkaido, Japan.; Department of Cardiology, Kurume University Medical Center, Fukuoka, Japan.

DOI: 10.1038/s41440-021-00754-7

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https://doi.org/10.1038/s41440-021-00754-7

MeSH Terms: Adult, Antihypertensive Agents, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Catheters, Denervation, Humans, Hypertension, Kidney, Sympathectomy, Treatment Outcome