SPYRAL HTN-ON MED
Trial question
What is the effect of renal denervation on BP in patients with uncontrolled hypertension on antihypertensive medications?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 80
80 patients (13 female, 67 male).
Inclusion criteria: patients with uncontrolled hypertension with office SBP between 150-180 mmHg and and DBP ≥ 90 mmHg and ambulatory SBP between 140-170 mmHg who were on 1-3 antihypertensive drugs with stable doses for at least 6 weeks.
Key exclusion criteria: lack of appropriate renal artery anatomy, eGFR < 45, T1DM mellitus, poorly-controlled T2DM mellitus, primary pulmonary hypertension.
Interventions
N=38 renal denervation (renal angiography and renal denervation with Symplicity Spyral multi-electrode renal denervation system).
N=42 sham intervention (renal angiogram with sensory masking post-angiogram).
Primary outcome
Change in 24-hour ambulatory systolic blood pressure from baseline to 6 months
-9 mmHg
-1.6 mmHg
0.0 mmHg
-2.3 mmHg
-4.5 mmHg
-6.8 mmHg
-9.0 mmHg
Renal
denervation
Sham
intervention
Significant
decrease ▼
Significant decrease in change in 24-hour ambulatory SBP from baseline to 6 months (-9 mmHg vs. -1.6 mmHg; AD -7 mmHg, 95% CI -12 to -2.1).
Secondary outcomes
Significant decrease in change in 24-hour ambulatory DBP from baseline to 6 months (-6 mmHg vs. -1.9 mmHg; AD -4.3 mmHg, 95% CI -7.8 to -0.8).
No significant difference in change in 24-hour HR at 6 months (-3.7 bpm vs. -1.5 bpm; AD -2.3 bpm, 95% CI -5.1 to 0.4).
No significant difference in change in office HR at 6 months (-5.1 bpm vs. -3.2 bpm; AD -1.4 bpm, 95% CI -4.7 to 1.8).
Safety outcomes
No significant differences in medication adherence, adverse events.
Significant difference in mean changes in ambulatory 24-hour SBP (-4.3 mmHg vs. -0.7 mmHg) and DBP (-4.2 mmHg vs. -0.8 mmHg).
Conclusion
In patients with uncontrolled hypertension with office SBP between 150-180 mmHg and and DBP ≥ 90 mmHg and ambulatory SBP between 140-170 mmHg who were on 1-3 antihypertensive drugs with stable doses for at least 6 weeks, renal denervation was superior to sham intervention with respect to change in 24-hour ambulatory SBP from baseline to 6 months.
Reference
Kandzari DE, Bohm M, Mahfoud F et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355.
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