- 著者
- Kazuomi Kario Eiichiro Yamamoto Hirofumi Tomita Takafumi Okura Shigeru Saito Takafumi Ueno Daiki Yasuhara Kazuyuki Shimada on behalf of the SYMPLICITY HTN-Japan Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-18-1018, (Released:2019-02-13)
- 参考文献数
- 32
- 被引用文献数
- 27
Background: SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal denervation (RDN) with standard pharmacologic therapy for treatment of uncontrolled hypertension (HTN). Methods and Results: Patients enrolled had uncontrolled HTN, defined as office systolic blood pressure (SBP) ≥160 mmHg and 24-h ambulatory SBP ≥135 mmHg, on ≥3 antihypertensive drugs of maximally tolerated dose for at least 6 weeks prior to enrollment. Randomization was 1:1 to RDN or maintenance of current medical therapy (control). Patients were followed every 6 months post-randomization for up to 36 months. There were 22 patients randomized to RDN and 19 to control, and 11 patients were crossed over and received RDN at 6 months post-randomization. For the RDN group (n=22), office SBP reduction was −32.8±20.1 mmHg and office DBP reduction was −15.8±12.6 mmHg at 36 months post-procedure, both P<0.001. For the combined RDN and crossover group (n=33), office SBP reduction was −26.7±18.9 mmHg and office DBP reduction was −12.7±11.8 mmHg at 30 months post-procedure, both P<0.001. There were no procedural-, device- or treatment-related safety events through 36 months. Conclusions: SYMPLICTY HTN-Japan is the first randomized controlled trial to evaluate RDN in an Asian population. Despite the small number of enrollments, results show patients who received RDN therapy maintained SBP reduction out to 36 months.
- 著者
- Kazuomi Kario Hisao Ogawa Ken Okumura Takafumi Okura Shigeru Saito Takafumi Ueno Russel Haskin Manuela Negoita Kazuyuki Shimada on behalf of the SYMPLICITY HTN-Japan Investigators
- 出版者
- 日本循環器学会
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-15-0150, (Released:2015-04-24)
- 参考文献数
- 28
- 被引用文献数
- 20 75
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.