Efficacy of Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications - SPYRAL HTN-OFF MED Pivotal
Contribution To Literature:
The SPYRAL HTN-OFF MED Pivotal trial showed that renal denervation was superior to sham at reducing blood pressure.
The goal of the trial was to evaluate renal denervation compared with sham among patients with uncontrolled hypertension.
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
- 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
- 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
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.
- 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
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.
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.
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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