Renal denervation reduces BP in high-risk comorbid conditions
Results from the Global SYMPLICITY Registry found that renal denervation conferred consistent BP reduction in patients with high-risk comorbidities regardless of their atherosclerotic CVD risk score.
“These findings reaffirm the efficacy and safety documented in the randomized, sham-controlled trials and extend these results to patients with various comorbidities and high cardiovascular risk,” Felix Mahfoud, MD, professor and director of the Clinic for Internal Medicine III at Saarland University Hospital in Homburg/Saar, Germany, told Healio.
Global SYMPLICITY Registry
For the study published in the Journal of the American College of Cardiology, researchers analyzed data from 2,652 patients from the Global SYMPLICITY Registry with uncontrolled hypertension and/or conditions linked to the activation of the sympathetic nervous system. In this international, single-arm, prospective registry, all patients were treated with the Symplicity RDN system (Medtronic). Endpoints of interest included changes in medications and BP measurements.
Several post hoc analyses were performed including patients with atrial fibrillation, older patients, severe treatment-resistant hypertension, diabetes, chronic kidney disease and isolated systolic hypertension. ASCVD scores were calculated for patients with information on antihypertensive medications, office systolic BP measurements, cholesterol levels, and smoking and diabetic status.
Researchers made several comparisons within subgroups regarding BP changes over time and adverse event rates: older vs. younger than 65 years, AF vs. no AF, diabetes vs. no diabetes and isolated systolic hypertension vs. no isolated systolic hypertension. Adverse events and BP reduction were assessed during a 3-year period.
“Catheter-based renal denervation has proven its efficacy and safety in recently published sham-controlled trials, which included patients with mild to moderate uncontrolled hypertension treated with no or one to three antihypertensive drugs,” Mahfoud said in an interview. “Patients with comorbidities and severe hypertension on multiple medication at high cardiovascular risk have not been included. This study aimed at assessing blood pressure reduction and event rates after [renal denervation] in patients with various comorbidities, testing the hypothesis that [renal denervation] is effective and durable in these high-risk populations.”
Of the patients in the registry, 2,466 patients achieved 3-year follow-up.
At 3 years, reductions in 24-hour systolic BP were 8.9 mm Hg for the overall cohort compared with baseline (P < .0001). For high-risk subgroups, BP reduction was 8.7 mm Hg for patients aged at least 65 years, 10.4 mm Hg for resistant hypertension, 8.6 mm Hg for isolated systolic hypertension and 10.2 mm Hg for diabetes (P for all < .0001). In addition, reductions in BP were also observed in patients with AF (10 mm Hg) and those with chronic kidney disease (10.1 mm Hg; P for all < .0001).
Patients who exhibited BP reduction with measurements taken at 6, 12, 24 and 36 months had similar reductions in 24-hour and in-office systolic BP for varying baseline ASCVD risk scores. This effect was sustained to 3 years.
Compared with patients with lower ASCVD risk scores, those with ASCVD risk scores of 20% and greater had higher rates of CV death (4.5%), death (8.4%) and hospitalization for AF (6.3%) or new-onset HF (5.3%) at 3 years.
“It would be important to investigate the impact of [renal denervation] on hard cardiovascular outcomes in the setting of randomized controlled trials focusing on patients at high cardiovascular risk, eg, patients with atrial fibrillation or coronary artery disease,” Mahfoud told Healio.
Unresolved ‘holy grail’
In a related editorial, Stephen C. Textor, MD, consultant in the division of nephrology and hypertension and professor of medicine at Mayo Clinic, wrote: “The outcomes reported here suggest that age, diabetes, isolated systolic hypertension, chronic kidney disease or other demographic data do not reliably demarcate the populations likely to respond to renal denervation. Identifying the truly optimal candidates for renal denervation remains the unresolved ‘holy grail’ for this technology.”
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For more information:
Felix Mahfoud, MD, can be reached at felix.mahfoud@uks.eu; Twitter: @felixmahfoud.
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