SYMPLICITY HTN-Japan - First Randomized Controlled Trial of Catheter-Based Renal Denervation in Asian Patients -
Kazuomi Kario, Hisao Ogawa, Ken Okumura, Takafumi Okura, Shigeru Saito, Takafumi Ueno, Russel Haskin, Manuela Negoita, Kazuyuki Shimada, SYMPLICITY HTN-Japan Investigators, Shigeru Saito, Kazuomi Kario, Yuji Okuyama, Takeshi Kimura, Ken Okumura, Kazutaka Aonuma, Yoshio Kobayashi, Takafumi Ueno, Hisao Ogawa, Tetsuji Miura, Atsuhiro Ichihara, Yoshitaka Hirooka, Kengo Tanabe, Naoyuki Hasebe, Kazuomi Kario, Hisao Ogawa, Ken Okumura, Takafumi Okura, Shigeru Saito, Takafumi Ueno, Russel Haskin, Manuela Negoita, Kazuyuki Shimada, SYMPLICITY HTN-Japan Investigators, Shigeru Saito, Kazuomi Kario, Yuji Okuyama, Takeshi Kimura, Ken Okumura, Kazutaka Aonuma, Yoshio Kobayashi, Takafumi Ueno, Hisao Ogawa, Tetsuji Miura, Atsuhiro Ichihara, Yoshitaka Hirooka, Kengo Tanabe, Naoyuki Hasebe
Abstract
Background: SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal artery denervation (RDN) with standard pharmacotherapy for treatment of resistant hypertension (systolic blood pressure [SBP] ≥160 mmHg on ≥3 anti-hypertensive drugs including a diuretic for ≥6 weeks). When SYMPLICITY HTN-3 failed to meet the primary efficacy endpoint, the HTN-Japan enrollment was discontinued before completion. METHODS AND RESULTS: The 6-month change in office and 24-h ambulatory SBP were compared between RDN (n=22) and control (n=19) subjects. Mean baseline office SBP was 181.0±18.0 mmHg and 178.7±17.8 mmHg for the RDN and control groups, respectively. The 6-month office SBP change was -16.6±18.5 mmHg for RDN subjects (P<0.001) and -7.9±21.0 mmHg for control subjects (P=0.117); the difference between the 6-month change in RDN and control subjects was -8.64 (95% CI: -21.12 to 3.84, P=0.169). Mean 24-h SBP was 164.7±18.3 (RDN group) and 163.3±17.2 mmHg (control group). The 24-h 6-month SBP change for the RDN group was -7.52±11.98 mmHg (P=0.008) and -1.38±10.2 mmHg (P=0.563) for control subjects; the between-group difference in SBP change was -6.15 (95% CI: -13.23 to 0.94, P=0.087). No major adverse events were reported.
Conclusions: SYMPLICITY HTN-Japan, the first randomized controlled trial of RDN in an Asian population, was underpowered for the primary endpoint analysis and did not demonstrate a significant difference in 6-month BP change between RDN and control subjects.
Trial registration: ClinicalTrials.gov NCT01644604.
Source: PubMed