SYMPLICITY HTN-Japan - First Randomized Controlled Trial of Catheter-Based Renal Denervation in Asian Patients - .
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.
Department of Cardiovascular Medicine, Jichi Medical University School of Medicine.
Kazuomi
K
Kario
Hisao
H
Ogawa
Ken
K
Okumura
Takafumi
T
Okura
Shigeru
S
Saito
Takafumi
T
Ueno
Russel
R
Haskin
Manuela
M
Negoita
Kazuyuki
K
Shimada
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D044466:Asian People; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation; D003131:Combined Modality Therapy; D015897:Comorbidity; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000601:surgery*; D007564:Japan; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation*; D012107:Research Design; D018401:Sample Size; D013562:Sympathectomy / Q000379:methods*; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D000451:Mineralocorticoid Receptor Antagonists