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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&lt;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&lt;0.001. There were no procedural-, device- or treatment-related safety events through 36 months.

circulation journal

Sufficient and Persistent Blood Pressure Reduction in the Final Long-Term Results From SYMPLICITY HTN-Japan ― Safety and Efficacy of Renal Denervation at 3 Years ―