Renal denervation safely reduces BP through 3 years
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Renal denervation contributed to sustained BP reductions out to 3 years without increasing medication burden, researchers found.
Three-year safety and efficacy data from the Global SYMPLICITY Registry were presented at the virtual PCR e-Course.
“With a clear need for alternative treatment options, the study presents positive implications for clinical practice,” Felix Mahfoud, MD, cardiologist at Saarland University Medical Center in Homberg, Germany, told Healio. “With these data and the results of the positive sham-controlled study showing reductions in both office and 24-hour blood pressure that were sustained out to 3 years post-procedure, it reinforces that renal denervation is a viable, complementary option in hypertensive patients without requiring an increase in medication burden over time.”
Patients with uncontrolled hypertension
In this single-arm, multicenter, observational study, researchers analyzed data from 2,747 patients (mean age, 61 years; 58% men) with uncontrolled hypertension or other conditions related to increased sympathetic activity. Patients underwent renal denervation with one of two catheters: Symplicity Flex (Medtronic; n = 2,231) or Symplicity Spyral (Medtronic; n = 516).
“The Global SYMPLICITY Registry is the largest study documenting the long-term safety and effectiveness of the Medtronic renal denervation systems in a real-world setting in patients with uncontrolled hypertension,” Mahfoud said in an interview.
Office BP decreased by 13.3 mm Hg systolic at 6 months and 16.7 mm Hg systolic at 3 years (P < .001). Decreases were also observed for 24-hour ambulatory BP monitoring, with a 7.5 mm Hg systolic decrease at 6 months and a 9.2 mm Hg systolic decrease at 3 years (P < .001).
When patients were matched with those with baseline, 6-month and 3-year office BP measurements, office BP decreased by 12.7 mm Hg systolic at 6 months and 16.3 mm Hg systolic at 3 years (P < .001). Twenty-four-hour ambulatory BP monitoring also decreased at 6 months (6.9 mm Hg systolic) and continued through 3 years (9.4 mm Hg systolic; P < .001).
Renal denervation decreased BP independent of antihypertensive medication burden at baseline. At 3 years, office systolic BP decreased by 21.7 mm Hg in patients taking one to two antihypertensive medication, by 17.1 mm Hg in those taking three medications, by 18.4 mm Hg in patients taking four medications and by 15.2 mm Hg in those taking five or more medications (P for all < .001; P for trend = .29). The number of medications patients took did not increase from baseline to 3 years (4.56 to 4.39).
At 3 years, 5.5% of patients died and 0.3% had new renal artery stenosis of 70% and greater.
“As this study is the largest real-world study of patients receiving renal denervation, we look forward to the growth of evidence supporting renal denervation in both controlled clinical trials and real-world practice, as well as additional studies demonstrating the effects of renal denervation,” Mahfoud told Healio.
‘Meaningful blood pressure reductions’
“Following the positive SPYRAL HTN-OFF MED Pivotal data presented at ACC, these new data provide additional evidence on the safety and efficacy of renal denervation to help manage uncontrolled hypertension with study patients experiencing meaningful blood pressure reductions out to several years,” Dave Moeller, vice president and general manager of the coronary and renal denervation business at Medtronic, said in the release. “As the body of clinical evidence supporting renal denervation grows, we are encouraged by the outcomes observed in both controlled clinical trials and real-world practice.”
Perspective
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George L. Bakris, MD
There were a number of unanswered questions regarding both safety and efficacy of long-term denervation, and this study clearly provides an answer. It also provides needed data outside the trial setting.
We now know that renal denervation is safe after at least 3 years and that efficacy is currently maintained after this long period of time. Additionally, BP control improved a bit over time, and while there was not a dramatic difference in the number of medications added, BPs were lower and hence CV risk reduced. This is the kind of information registries provide, and it is very important from a practical standpoint.
If the technology is available, it should definitely be considered for people with resistant hypertension, especially in people who are nonadherent to medication regimens. If cost is not an issue, it can also be considered for those albeit rare patients who cannot tolerate any BP-lowering medications.
Most of the research relevant in this area has been completed in the HTN-3 and SPYRAL trials. We could look mechanistically at neurohumoral systems pre- and post-denervation to see at a basic science level the changes in humans. While some of this has been done, it has not been done using the current methodology.
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Mahfoud F, et al. PCR e-Course 2020 Abstracts. Presented at: PCR e-Course; June 25-27 (virtual meeting).
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