What is the clinical evidence from this study?

Study design: RCT. Population: Treatment-resistant essential hypertension (n=69). Intervention: Renal denervation vs. SHAM procedure. Primary outcome: Mean change in daytime systolic ABPM from baseline to 3 months (p=0.95).

May 25, 2016Journal of Hypertension141 citationsOpen Access

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

OMOle Norling Mathiassen HVHenrik Vase JBJesper Nørgaard Bech

Key Result

Renal denervation did not significantly reduce daytime systolic ambulatory blood pressure compared to a SHAM procedure at 3 months (-6.2 mmHg vs -6.0 mmHg, p=0.95) in patients with treatment-resistant hypertension.

Study Design

Type

RCT (n=69)

Blinding

Double-blind

Randomization

1:1

Multicenter

PICO

Population

69 patients aged 30 to 70 years with treatment-resistant essential hypertension and daytime systolic ABPM ≥145 mmHg, followed for 6 months.

Intervention / Comparator

Renal denervation vs SHAM procedure (4-6 discrete low-power radio frequency treatments per main renal artery using unipolar Medtronic Flex catheter)

Primary Outcome

Mean change in daytime systolic ABPM from baseline to 3 months, p=0.95

Main Result

Absolute Event Rate: -6.2% vs -6%

p-value: p=0.95

Limitations

Small sample size limiting the interpretation of short-term outcomes.
Use of older unipolar ablation catheters rather than newer multipolar catheters.
Lack of witnessed drug intake to confirm medication adherence before ABPM measurements.

Abstract

BACKGROUND: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. METHOD: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). RESULTS: We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months -6.2 ± 18.8 mmHg (RDN) vs. -6.0 ± 13.5 mmHg (SHAM) and at 6 months -6.1 ± 18.9 mmHg (RDN) vs. -4.3 ± 15.1 mmHg (SHAM). Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal 6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM).RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. CONCLUSION: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

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