Why is this study important?
- Long term three-year follow up of the largest randomized controlled renal denervation (RDN) study for control of hypertension.
- RDN is a suitable additive therapy in lowering blood pressure (BP) in selected patients with resistant hypertension (HTN) on multiple drug therapy.
What question was this study supposed to answer?
- Is RDN beneficial in resistant HTN?
- Is there a sustained reduction in systolic and diastolic BP in those with resistant hypertension on three or more antihypertensive drugs after invasive Radiofrequency (RF) RDN using first generation Symplicity Flex™ catheter (Medtronic corporation, Minneapolis, MN)?
What did the study show?
- Patients with resistant HTN Office SBP ≥160 mm Hg or 24hr ABPM ≥135 mm Hg on maximally tolerated dose of ≥3 anti-HTN medications were included in the study.
- This was a 2: 1 randomized, sham-controlled, blinded trial at 88 US sites, with 364 patients in RDN arm and 171 in sham control arm.
- No changes were allowed in anti-hypertensive therapy for 6 months.
- Baseline blood pressure in the group of patients who ultimately comprised the sham control and did not cross over had a much lower baseline systolic blood pressure and would have likely not had a comparable blood pressure reduction.
- Crossover was allowed to RDN at 6 months in the sham control arm.
- At 36 months the magnitude of BP reduction was greater than the first 12 or 24 months with average reduction of systolic BP by 22 mm Hg (P < 0.0001) and diastolic BP by 12 mm Hg (P < 0.0001)-this benefit was at 4.5 years.
- There were no long-term complications related to RDN.
All editors: S. Tanveer Rab, MD, FSCAI
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