This article is more than 5 years old. Information may no longer be current.
Global SYMPLICITY registry reveals low rate of adverse events with renal denervation system
Click Here to Manage Email Alerts
WASHINGTON — Results from the Global SYMPLICITY Registry have found that renal denervation with the Symplicity catheter was associated with a low rate of adverse events in real-world patients, as well as significantly lower BP at 6 months.
Michael Böhm, MD, PhD, chairman in the department of internal medicine, University of Saarland, Homburg/Saar, Germany, reported the data at the American College of Cardiology Scientific Sessions. Böhm and fellow researchers observed five adverse events attributed to renal denervation, including four vascular access site complications (0.34%) and one renal artery dissection, which was treated. They also reported low rates of stroke (0.9%), new-onset HF (0.7%), MI (0.6%) and death (0.4%); hospitalizations due to hypertensive emergency (1%) and atrial fibrillation (0.9%); and two cases of new-onset end-stage kidney disease (0.2%), which were considered unrelated to the procedure.
Researchers also reported significant reductions in 6-month office systolic BP of –11.9 mm Hg for all patients and –21.4 mm Hg for patients with baseline office BP ≥160 mm Hg.
Ambulatory systolic BP also decreased significantly for all patients at 6 months: –7.9 mm Hg for all patients and –8.2 mm Hg for patients with ambulatory systolic BP of ≥160 mm Hg.
Böhm and colleagues also compared the registry data with the sham-controlled SYMPLCITY HTN-3 trial presented at ACC Scientific Sessions yesterday.
“When we selected the same patients with high office BP above 160 and [ambulatory BP monitoring] above 135, there was a slightly more effective reduction in BP in the [registry] compared with SYMPLICITY HTN-3,” Böhm said at a press conference. “Even when we look here at patients with maximally tolerated doses of more than three drugs, there was more of a strong effect in the registry than the trial. The same holds true when we looked at Caucasian patients, because in the registry there was not one African American patient involved.”
In addition to the inclusion of African Americans, other differences with SYMPLICITY HTN-3, according to Böhm, include randomization, blinding, sham control, BP inclusion criteria and antihypertensive drug treatment intensity.
“Due to the nature of the registry, we cannot say anything about a potential placebo effect,” Böhm added.
For the prospective, open-label, multicenter Global SYMPLICITY Registry, the researchers collected procedural details, office and 24-hour ambulatory BP, renal function, vascular complications and other protocol-defined safety events. They enrolled 1,000 consecutive patients and followed them for 6 months.
At baseline, patients had a mean age 61 ± 12 years, 60% were men and 30% had at least one comorbidity — 49% cardiac disease, 41% diabetes, 30% chronic kidney disease and 17% sleep apnea. Also at baseline, patients were taking a mean of four antihypertensive medications and had a mean office BP of 164/89 ± 24/16 mm Hg.
The study’s primary endpoint was safety — periprocedural and long term— and secondary endpoints were patient characterization, effect on BP and changes in baseline antihypertensive medication.
The Global SYMPLICITY Registry represents the first and largest dataset of patients with uncontrolled hypertension treated with renal denervation to date. – by Brian Ellis
For more information:
Böhm M. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, DC.
Disclosure: The study was funded by Medtronic. Böhm reports several financial disclosures with device and pharmaceutical manufacturers, including Medtronic.
Perspective
Back to Top
Allan S. Jaffe, MD
The results from the SYMPLICITY registry are different from that of the randomized trial, and what it says, I think, is that perhaps there are going to be subsets or tweaks to the method that will be done in the long term that are going to be beneficial. But I certainly think that randomized controlled trials have to hold sway here and cause a major break in what’s going on while additional research is done. Maybe refinements or a better understanding of how you denervate totally are needed. Maybe it’s subsets of patients that benefit. But the science is attractive, so we have more work to do. In that sense, I am glad that we were laggards in the United States.
Click Here to Manage Email Alerts