Subjects who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared to subjects in the sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM) due to increased medications in the sham control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment. The study also included
"The ON MED study demonstrated significant reductions in office-based blood pressure, the most commonly used measure in clinical practice. Additionally, we saw reductions in absolute blood pressure that were consistent with earlier RDN studies," said David Kandzari, M.D., chief,
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency (RF)-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers. A total of 337 patients with uncontrolled hypertension were enrolled at 42 sites across
- The primary Bayesian efficacy endpoint of 24-hr systolic ABPM reduction was not met, with a 51% probability of superiority for the RDN group versus those who received a sham control procedure. However, nighttime systolic ABPM reduction was statistically significant.
- 6.5 mmHg 24-hr systolic ABPM reduction in the RDN group versus 4.5 mmHg in the control group (treatment difference of -1.9 mmHg, p=0.119)
- 6.7 mmHg nighttime systolic ABPM reduction in the RDN group versus 3.0 mmHg in the control group (treatment difference of -3.7 mmHg, p=0.01)
- The study met the prespecified secondary endpoint, which was the change in OSBP from baseline to six-month follow-up between the RDN group (n=199) and the sham control group (n=126).
- Statistically significant 9.9 mmHg OSBP reductions in the RDN group versus a 4.9 mmHg reduction in the sham control group (treatment difference of -4.9 mmHg, p=0.001)
- The study met the primary safety endpoint, evaluating major adverse events at one-month post-procedure, and renal artery stenosis at six-months, pooled across the SPYRAL HTN-ON and OFF MED studies (p<0.001)
- RDN demonstrated a low incidence of procedure-related and clinical adverse events at six-months in the SPYRAL HTN-ON MED study specifically.
- The
Win Ratio demonstrated significance in favor of RDN versus a sham procedure (p=0.005). - Overall burden of medications was higher in the sham control group at six-months (p=0.04).
"Renal denervation lowers blood pressure and requires less medication for patients with hypertension," said
The SPYRAL HTN-ON MED Trial4 is a part of the Medtronic SPYRAL HTN Global Clinical Program – the most comprehensive clinical program studying RDN - including the SPYRAL HTN-OFF MED Pivotal Trial5 and the currently-enrolling SPYRAL AFFIRM Study. Along with the real-world data from the Global SYMPLICITY Registry (GSR)6, the Medtronic RDN program is backed by experience in more than 20,000 patients treated globally, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk.
"In addition to the consistent absolute blood pressure drops that we have demonstrated across trials, long-term data from key Medtronic studies— which were highlighted in two important publications this year in
Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral RDN system is limited to investigational use in
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2 Azzouzzi et al. Int. J. Environ. Res. Public Health 2022 |
3 Laffin et al. Circulation 2021 |
4 Kandzari D, Bӧhm 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. |
5 Bӧhm M, Kario K, Kandzari D et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. |
6 Mahfoud F, Mancia G, Schmieder R, et al. Renal denervation in high-risk patients with hypertension. J Am Coll Cardiol 2020; 75: 2879-88. |
7 Mahfoud, F, Kandzari, D, Weber, M et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. |
8 Bhatt DL, Vaduganathan M, Kandzari DE, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. |
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