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

2021; Springer Nature; Volume: 45; Issue: 2 Linguagem: Inglês

10.1038/s41440-021-00754-7

1348-4214

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,

Hemodynamic Monitoring and Therapy

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 ).