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Catheter-Based Renal Denervation for Resistant Hypertension

March 29, 2014

Catheter-Based Renal Denervation for Resistant Hypertension

  1. Allan S. Brett, MD

This procedure did not lower blood pressure significantly in a sham-controlled trial.

  1. Allan S. Brett, MD

Catheter-based radiofrequency denervation of the renal arteries has recently been developed as a possible treatment alternative for resistant hypertension. In the SYMPLICITY HTN-2 trial, renal denervation lowered blood pressure (BP) significantly at 6 months, compared with no intervention, in patients with resistant hypertension (NEJM JW Gen Med Dec 28 2010). Now we have the next step: the sham-controlled SYMPLICITY HTN-3 trial. The trial involved 535 patients with mean office systolic BPs >160 mm Hg despite treatment with at least three BP drugs at maximally tolerated doses. Patients were randomized to renal angiography plus renal-artery denervation or to a sham procedure (renal angiography only). Medication changes were not permitted during follow-up unless compelling reasons developed.

At 6 months, mean office systolic BP decreased by 14 mm Hg in the denervation group and 12 mm Hg in the sham group, a nonsignificant difference. Additionally, no differences were seen between groups in diastolic BP or 24-hour ambulatory BP measurements. Medications were changed in a minority of participants, with no differences between groups in types and numbers of medication changes. No major adverse events were noted.

Comment

This sham-controlled trial did not confirm previously reported positive results from uncontrolled or non-placebo-controlled studies; thus, renal denervation should still be considered unproven. Follow-up in SYMPLICITY HTN-3 will continue for 5 years to determine whether benefits or harms will emerge with time. Long-term outcomes of interest include not only blood pressure control but also effects on cardiovascular and renal endpoints. Finally, the procedure could have value if it allowed a patient with resistant hypertension to maintain a consistent BP while eliminating several poorly tolerated drugs.

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose

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