The randomised Oslo study of renal denervation vs. Antihypertensive drug adjustments: efficacy and safety through 7 years of follow-up

Abstract

Purpose

The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study.

Materials and methods

Patients with treatment-resistant hypertension, defined as daytime systolic ambulatory BP ≥135 mmHg after witnessed intake of ≥3 antihypertensive drugs including a diuretic, were randomised to either RDN (n = 9) or drug adjustment (n = 10). The initial primary endpoint was the change in office BP after 6 months. The RDN group had their drugs adjusted after 1 year using the same principles as the Drug Adjustment group. Both groups returned for long-term follow-up after 3 and 7 years.

Results

The decrease in office BP and ambulatory BP (ABPM) after 6 months did not persist, but gradually increased in both groups. From 6 months to 7 years follow-up, mean daytime systolic ABPM increased from 142 ± 10 to 145 ± 15 mmHg in the RDN group, and from 133 ± 11 to 137 ± 13 mmHg in the Drug Adjustment group, with the difference between them decreasing. In a mixed factor model, a significantly different variance was found between the groups in daytime systolic ABPM (p = .04) and diastolic ABPM (p = .01) as well as office diastolic BP (p<.01), but not in office systolic BP (p = .18). At long-term follow-up we unveiled no anatomical- or functional renal impairment in either group.

Conclusions

BP changes up to 7 years show a tendency towards a smaller difference in BPs between the RDN and drug adjustment patients. Our data support RDN as a safe procedure, but it remains non-superior to intensive drug adjustment 7 years after the intervention.

Keywords:

• Treatment-resistant hypertension
• renal denervation
• long-term follow-up
• safety

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Acknowledgements

The authors thank Prof. Emeritus Knut Liestøl at the Department of Informatics, University of Oslo, research bioengineer Vibeke N. Kjær at the Section for Cardiovascular and Renal Research, Oslo University Hospital, Ullevål and Prof. Morten Rostrup at the Department of Behavioral Sciences in Medicine, University of Oslo and Department of Acute Medicine at Oslo University Hospital, Ullevål for their valuable contributions to this work.

Disclosure statement

The authors disclose no relevant conflicts of interest.

Additional information

Funding

This study was funded by The South-Eastern Norway Regional Health Authority.