1. The intervention group saw a 10 mmHg greater reduction in 24-h mean systolic blood pressure compared to the sham group at 36 months.
2. There was no difference in adverse events between the two groups and no difference seen in serum creatinine and eGFR after 36 months.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Hypertension is a major cause of premature death worldwide with numerous different targeted pharmaceuticals on the market. An interventional treatment method called renal denervation has been shown to lower blood pressure with antihypertensives in previous studies. The SPYRAL HTN-ON MED trial enrolled 80 patients with poorly controlled hypertension on antihypertensives. The participants were randomized 1:1 to undergo either radiofrequency ablation of their renal arteries and branch vessels or a sham control intervention. The study found that compared to the sham control group, patients who underwent renal denervation had a significant reduction in blood pressure after 24 months. This reduction was greater at the 36-month time point. There were no adverse events or variations in renal function blood tests related to the renal denervation treatment. Limitations of this study include the inability to perform full surveillance of compliance of prescribed antihypertensives, which were continued throughout the study. Nonetheless, this study presents promising results regarding the safety and efficacy of renal denervation with antihypertensives to combat hypertension.
Relevant Reading: Pharmacological blood pressure lowering for primary and secondary prevention of cardiovascular disease across different levels of blood pressure: an individual participant-level data meta-analysis
In-Depth [randomized control trial]: The SPYRAL HTN-ON MED trial was a randomized sham-controlled trial. Eligibility criteria included a systolic blood pressure between 150-180 mmHg, diastolic ≥ 90 mmHg and mean 24-h systolic blood pressure of 140-170 mmHg. Patients were on one to three antihypertensive medications prior to study enrollment. 80 patients were randomly assigned 1:1 to receive either renal denervation (n=38) or sham control (n=42). The procedure of renal denervation utilized radiofrequency ablations of the renal arteries and branch vessels. Patients remained on their prescribed blood pressure medication regimen during the study period.
After 36 months, there were no significant differences in the antihypertensive burden between the two groups. However, at 36 months, the reduction in systolic blood pressure was -18.7 mm Hg for the intervention group and -8.6 mm Hg for the sham control group (adjusted treatment difference -10.0 mm Hg, 95% CI -16.6 to -3.3, p=0.0039). This demonstrated a further reduction from the values recorded at 24 months. There was no difference in eGFR, serum creatinine, sodium levels and potassium levels between the two groups at 24 and 36 months. There were three severe safety events during the 36 months: one death of unknown cause in the sham group and one stroke and hypertensive crisis in the treatment group. There were no cases of renal artery stenosis or need for re-intervention in the treatment group.
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