Physicians' Academy for Cardiovascular Education

Renal denervation reduces BP in hypertensive patients in absence of medications

News - Apr. 2, 2020

Catheter-based Renal Denervation In The Absence Of Antihypertensive Medications: Primary Results From The SPYRAL HTN-OFF MED Pivotal Trial

Presented at ACC.20 by Prof. Michael Böhm, MD, PhD (Homburg, Germany)

Introduction and methods

Renal denervation (RDN) targets renal artery nerves in order to reduce sympathetic drive and lower blood pressure (BP). The SPYRAL HTN-OFF MED Pivotal Trial enrolled patients with hypertension (office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, office diastolic blood pressure ≥90 mmHg and mean 24-hour SBP ≥140 mmHg and <170 mmHg using ambulatory blood pressure monitoring [ABPM]) and who were not on hypertension medication or had discontinued therapy for at least 3 weeks before enrollment.

Before randomization, office BP and 24h SBP were measured at baseline and patients were tested on the absence of drugs in the urine. Patients were randomized to either RDN (n=162) or sham control (n=164). After a follow-up of three months office BP and 24h SBP were measured and drug testing was repeated.

The primary endpoint was change in 24h SBP and the secondary endpoint was change in office SBP, both at 3 months.

Main results

Conclusion

This trial showed that RDN lowers 24h SBP and office SBP compared to sham control in uncontrolled hypertensive patients in the absence of medications. 24h SBP curves showed consistent BP reduction over 24 hours in the RDN group. The follow-up study SPYRAL HTN – ON MED, in which this procedure will be tested in patients who are on hypertension medications, is currently enrolling.

Discussion

The discussant Dhanunjaya Lakkireddy (Overland Park, KS, USA) pointed out that in the past there has been a substantial amount of conflicting data, confusion and high complication rates in trials investigating renal denervation. In this trial, patients were off medications, which was different compared to previous trials, to prevent confusion about the impact of medications on outcomes. Furthermore, it was a sham-controlled trial, and there is an impressive lack of complications. The reductions in BP that were observed in this trial are reasonably impressive for an antihypertensive study. However, the reductions in BP are not enough to make this a stand-alone therapy, according to Lakkireddy. Adding RDN on top of hypertensive medications could potentially be a reasonable strategy, which will be investigated in the follow-up study.

- Our coverage of ACC.20 is based on the information provided during the congress –

The SPYRAL HTN-OFF MED Pivotal Trial results were published simultaneously in The Lancet

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