Physicians' Academy for Cardiovascular Education

Expansion of trial with RDN in patients on hypertensive medication

News - Nov. 8, 2022

Effect of Radiofrequency Renal Denervation on Blood Pressure in the Presence of Antihypertensive Drugs: 6-Month Primary Results From the SPYRAL HTN-ON Med Expansion Randomized Trial

Presented at the AHA Scientific Sessions 2022 by: David Kandzari - Atlanta, GA, USA

Introduction and methods

A catheter-based renal denervation (RDN) procedure targets the sympathetic nervous system to lower blood pressure (BP). Previous sham-controlled trials showed significant lowering of BP with radiofrequency RDN in the absence and presence of antihypertensive medication (SPYRAL HTN-OFF MED Pivotal and SPYRAL HTN-ON MED Pilot), with long-term data of SPYRAL HTN-ON Med up to 3 years.

This study examined the outcomes of RDN in the presence of antihypertensive medication in an extension cohort in an international sham-controlled RCT.

In the SPYRAL HTN-ON MED Expansion trial, 257 patients were enrolled with uncontrolled hypertension (office SBP ≥150 to <180) who were prescribed 1 to 3 antihypertensive medication classes. Patients were randomized in a 2:1 ratio to a renal denervation group and a sham control group. There were 80 patients in the PILOT cohort, resulting in an ON MED Full Cohort of 337 patients.

In the ON MED PILOT study, a significant difference favoring RDN was found for 24h systolic ABPM (7.3 mmHg) and office systolic BP (6.6 mmHg).

The primary efficacy outcome was the 6-month change in 24h systolic ambulatory BP (ABPM). Primary safety endpoint was major adverse events at 1 month in pooled trials (SPYRAL HTN-OFF and ON MED).

Main results

Safety outcomes

Efficacy outcomes

Exploratory analyses


In the SPYRAL HTN-ON MED Full cohort population, there was no significant change in systolic ABPM after 6 months between the RND and sham control groups. Office BP however was more reduced in the RND group after 6 months than in the sham control group. Furthermore, the primary safety endpoint across SPYRAL HTN trials was met with low incidence of procedural-related and clinical adverse events.

- Our reporting is based on the information provided at the AHA Scientific Sessions 2022 -

Read our summary of SPYRAL HTN-ON MED

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