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Renal denervation failed to reduce MACE at 1 year
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BARCELONA, Spain — Similar to results observed at 6 months, renal denervation was safe but did not reduce the rate of MACE at 1 year compared with a sham procedure, according to new data from the SYMPLICITY HTN-3 trial.
The study was presented here at ESC Congress by George Bakris, MD, trial co-principal investigator and Cardiology Today Editorial Board member.
As reported earlier, SYMPLICITY HTN-3 was the first randomized, blinded, sham-controlled clinical trial assessing renal denervation (Symplicity, Medtronic) in the setting of treatment-resistant hypertension. The present analysis included 12-month follow-up of originally denervated patients (322 of 361 patients) and 6-month follow-up of the crossover patients (93 of 101 patients), who were denervated after unblinding at 6 months if BP criteria for treatment were met and patients chose to continue in the trial.
George Bakris
Bakris, from the University of Chicago Medicine, reported that among patients who crossed over to renal denervation at 6 months, office BP reductions were –17.7 mm Hg/–7.1 mm Hg, whereas for those who were initially treated with renal denervation, office BP reductions were –15.3 mm Hg/–6.6 mm Hg at 6 months and –18.9 mm Hg/–7.8 mm Hg at 12 months (P<.001 for all).
“Although it looked like there was an additional BP reduction at the end of 1 year compared with 6 months, that was not statistically significant,” Bakris said during a press conference. “Likewise when you look at the crossover group … their magnitude of fall is similar to the original 6-month data seen in the patients who were originally denervated.”
Change in mean 24-hour ambulatory BP was –6.8 mm Hg/–4.1 mm Hg at 6 months and –7.6 mm Hg/–4.7 mm Hg at 12 months for patients initially treated with renal denervation compared with –9.2 mm Hg/–4.9 mm Hg for crossover patients (P<.001 for all).
Moreover, for non-crossover patients, change in office BP was –32.9 mm Hg/–13.3 mm Hg at 6 months and –21.4 mm Hg/–8.2 mm Hg at 12 months (P<.001 for all), and change in mean 24-hour ambulatory BP was –11 mm Hg/–6.6 mm Hg (systolic P=.02; diastolic P=.03) at 6 months and –6.1 mm Hg/–2.9 mm Hg (P for both=NS) at 12 months.
Bakris said the safety profile at 12 months was similar to what was observed at 6 months, with no significant differences between the groups regarding the composite safety endpoint.
“Renal denervation with the Symplicity system is safe with no difference in major adverse events between the treated and original sham procedure groups going out to 12 months,” Bakris said. “All [patient groups] showed similar reductions in office and ambulatory BP readings at 12 months. Possible confounding factors include the population studied, drug prescription changes, variable adherence to therapy and procedural variability, which all remain unresolved and under investigation at this time.”
Regarding the present state of renal denervation, Bakris said there are a lot of procedural and anatomical aspects that are currently being learned.
“I would say [renal denervation] is a work in progress,” he said. “But it’s definitely not dead. In fact, I would say that it’s out of the ICU right now and probably on the floor.” – by Brian Ellis
For more information:
Bakris G. Clinical Trial Updates. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.
Disclosure: Bakris reports serving as a consultant for Bayer AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Daiichi Sankyo, Janssen Pharmaceuticals, Medtronic and Relypsa. His institution receives research support from Takeda Pharmaceutical.
Perspective
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Patrick O’Gara, MD, FACC
This analysis of the SYMPLICITY HTN-3 trial looked at 12-month outcomes on three groups of patients: Patients who were initially treated with RDN, and those who were initially treated medically and half of that group which crossed over to renal denervation 6 months after the initial randomization. It looks as if BP was directionally and proportionately reduced in all three groups. Taking a step back, it still seems that medical therapy in this trial was comparable to renal denervation for BP reduction. We heard from Dr. Bakris that perhaps additional investigation is required based on questions that have been raised in terms of the manner in which denervation was performed: the number of lesions and vessels and some technical issues that have been called into question since the results were first released.
Going forward, I think the community will be interested to see whether more precise methods of denervation will make a difference on hard outcomes. We need to get beyond BP reduction, as was the initial intent of this particular group. I would take Dr. Bakris’ comments at face value that the proposition is not dead. We have learned quite a bit scientifically about the distribution of nerve endings across renal arteries and also the manner in which you can test the effectiveness of the denervation strategy once performed. It seems to me that in the first iteration, it was somewhat of a blind shot, hoping for the best, and that maybe we will be more precise in the future.
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