6/29/23, 11:45 PM SPYRAL HTN-ON MED Pathway Feedback Search Clinical Topics Home Studies SPYRAL HTN ON MED SPYRAL HTN ON MED Disease Hypertension 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 N = 80 84.0% male 80 patients (13 female, 67 male) Inclusion criteria: patients with uncontrolled hypertension with office systolic BP between 150-180 mmHg and and diastolic BP 90 mmHg and ambulatory systolic BP 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) https://web.pathway.md/studies/reckxHgW0xqat4kFu 1/2 6/29/23, 11:45 PM SPYRAL HTN-ON MED Pathway Primary outcome Significant decrease in change in 24-hour ambulatory systolic BP and diastolic BP 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 office systolic BP and diastolic BP from baseline to 6 months (-9.4 mmHg vs. -2.6 mmHg; AD -6.6 mmHg, 95% CI -12.4 to -0.9) 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 systolic BP (-4.3 mmHg vs. -0.7 mmHg) and diastolic BP (-4.2 mmHg vs. -0.8 mmHg). Conclusion In patients with uncontrolled hypertension with office systolic BP between 150-180 mmHg and and diastolic BP 90 mmHg and ambulatory systolic BP 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 systolic BP and diastolic BP 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. Open reference URL https://web.pathway.md/studies/reckxHgW0xqat4kFu 2/2