Efficacy of Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications - SPYRAL HTN-OFF MED Pivotal

May 13, 2020
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Presenter/Author:
Michael Böhm
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medtronic; German Research Foundation
Date Presented:
03/29/2020
Date Published:
03/29/2020
Date Updated:
05/13/2020
Original Posted Date:
03/29/2020
References

Contribution To Literature:

The SPYRAL HTN-OFF MED Pivotal trial showed that renal denervation was superior to sham at reducing blood pressure.

Description:

The goal of the trial was to evaluate renal denervation compared with sham among patients with uncontrolled hypertension.

Study Design

  • Randomized
  • Parallel
  • Sham

Patients with uncontrolled hypertension not on antihypertensive therapy were randomized to renal denervation (n = 166) versus sham (n = 165).

  • Total number of enrollees: 331
  • Duration of follow-up: 3 months
  • Mean patient age: 52 years
  • Percentage female: 35%
  • Percentage with diabetes: 3.6

Inclusion criteria:

  • Patient not on antihypertensive medication or permitting discontinuation of drug therapy
  • Office systolic blood pressure ≥150 and <180 mm Hg
  • Office diastolic blood pressure ≥90 mm Hg
  • Systolic 24-hour mean ambulatory blood pressure monitoring ≥140 and <170 mm Hg

Exclusion criteria:

  • Ineligible renal artery anatomy
  • Estimated glomerular filtration rate <45 ml/min/1.73 m2
  • Type 1 diabetes or type 2 diabetes with glycated hemoglobin A1c >8.0%
  • Secondary hypertension

Other salient features/characteristics:

  • Baseline office systolic blood pressure: 163 mm Hg
  • Baseline office diastolic blood pressure: 101 mm Hg
  • Baseline 24-hour mean systolic blood pressure: 151 mm Hg
  • Baseline 24-hour mean diastolic blood pressure: 98 mm Hg
  • Total number of ablations per patient: 47

Principal Findings:

The co-primary outcome, change in 24-hour systolic blood pressure at 3 months, was -4.7 mm Hg in the renal denervation group compared with -0.6 mm Hg in the sham group (p < 0.001).

The co-primary outcome, change in 24-hour diastolic blood pressure at 3 months, was -3.7 mm Hg in the renal denervation group compared with -0.8 mm Hg in the sham group (p < 0.001).

The co-primary outcome, change in office systolic blood pressure at 3 months, was -9.2 mm Hg in the renal denervation group compared with -2.5 mm Hg in the sham group (p < 0.001).

The co-primary outcome, change in office diastolic blood pressure at 3 months, was -5.1 mm Hg in the renal denervation group compared with -1.0 mm Hg in the sham group (p < 0.001).

The effect of renal denervation was the same in various tested subgroups.

Secondary outcomes:

  • Proportion of patients placed on antihypertensive therapy due to systolic blood pressure >180 mm Hg or for safety reasons: 9.6% of the renal denervation group compared with 17.0% of the sham group (p = 0.049)
  • Major adverse events: 0.6% of the renal denervation group compared with 0% of the sham group

Interpretation:

Among patients with uncontrolled hypertension, renal artery denervation compared with sham was associated with a significant reduction in blood pressure. At 3 months, renal denervation compared with sham was associated with a 4.0 mm Hg reduction in 24-hour systolic blood pressure, a 3.1 mm Hg reduction in 24-hour diastolic blood pressure, a 6.6 mm Hg reduction in office systolic blood pressure, and a 4.4 mm Hg reduction in office diastolic blood pressure.

There were no major device- or procedure-related safety events. SPYRAL HTN-ON MED is currently enrolling patients.

References:

Böhm M, Kario K, Kandzari DE, 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. Lancet 2020;395:1444-51.

Presented by Dr. Michael Böhm at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 29, 2020.

Böhm M, Townsend RR, Kario K, et al. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol 2020;109:289-302.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Hypertension

Keywords: acc20, ACC Annual Scientific Session, Antihypertensive Agents, Blood Pressure, Blood Pressure Determination, Blood Pressure Monitoring, Ambulatory, Denervation, Diastole, Hypertension, Primary Prevention, Renal Insufficiency, Systole


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