There's an intriguing plot twist in the story of SYMPLICITY HTN-3, the sham-controlled clinical trial that nearly put the kibosh on renal denervation (RDN) therapy as a promising approach to treatment-resistant hypertension (HTN).
The trial famously showed no benefit for systolic blood pressure (BP) from the invasive procedure at 6 months and 12 months, dampening enthusiasm for RDN in HTN for both physicians and industry. But it turns out that disappointment in the study may have been premature.
The procedure led to significant improvements in systolic BP, whether in-office or ambulatory, compared with a sham control procedure, in a new analysis that followed the trial's patients out to 3 years. Those who underwent RDN also required less intense antihypertensive drug therapy.
"These findings support that durable blood pressure reductions with radiofrequency renal artery denervation, in the presence of lifestyle modification and maximal medical therapy, are safely achievable," said Deepak L. Bhatt, MD, in a September 18 presentation at Transcatheter Cardiovascular Therapeutics (TCT) 2022, held in Boston, Massachusetts.
Bhatt, of Boston's Brigham and Women’s Hospital and Harvard Medical School, is also lead author on the report published the same day in The Lancet.
Strides in RDN technology and trial design since the neutral primary SYMPLICITY HTN-3 results were reported in 2014 have long since restored faith in the procedure, which is currently in advanced stages of clinical trials and expected to eventually make a mark on practice.