Renal denervation therapy improves time in BP target range, reduces CV risk
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Renal denervation therapy is associated with a sustained reduction in BP out to 3 years as well as an improvement in time spent in the recommended BP target range, with registry data showing the results translate to improved CV outcomes.
Presenting data from three late-breaking clinical trials on renal denervation therapy at EuroPCR, researchers noted that the therapy could serve as a meaningful solution for patients across the spectrum of hypertension, regardless of the number of antihypertensive medications taken.
“Despite all advances in care, we still have a significant proportion of patients who are still undiagnosed or not sufficiently controlled to target BP, and that holds true for almost all regions around the world,” Felix Mahfoud, MD, a cardiologist at Saarland University Medical Center in Homberg, Germany, said during a press conference before the data were presented. “We also know from large meta-analyses that reducing BP is impactful for patients. ... Modest reductions in office BP translate to significant improvements in outcomes. The problem is we have available drugs and many patients do not take them. There is an unmet need and renal denervation represents a device-based treatment option to tackle that problem.”
New SPYRAL HTN-ON MED data
Adults who underwent radiofrequency renal denervation therapy while taking antihypertensive medications spent more time in the recommended target BP range for 3 years compared with similar patients who underwent a sham procedure, researchers reported.
“Most individuals with hypertension do not meet societal or guideline-recommended treatment goals and studies indicate a waning control over time, in part due to nonadherence to pharmacotherapy and/or lifestyle interventions,” David E. Kandzari, MD, FACC, FSCAI, director of interventional cardiology at Piedmont Heart Institute in Atlanta and chief scientific officer of Piedmont Healthcare, said during a press conference. “Renal denervation therapy with radiofrequency energy delivery has achieved statistically significant, clinically relevant reductions in BP. Time in target range is an independent measure of BP controls and is predictive of adverse events.”
As Healio previously reported, the 36-month findings of the SPYRAL HTN-ON MED trial of the catheter-based treatment (Symplicity Spyral, Medtronic) demonstrated that, in patients with treatment-resistant hypertension, despite taking one to three BP-lowering medications, radiofrequency renal denervation conferred BP reduction out to 36 months. At baseline, all patients had office systolic BP 150 mm Hg to 180 mm Hg, office diastolic BP 90 mm Hg or higher and 24-hour ambulatory systolic BP 140 mm Hg to 170 mm Hg.
The researchers randomly assigned 80 patients (mean age, 53 years; 84% men) to radiofrequency renal denervation or a sham procedure.
At 36 months, the number of medications taken was similar between the groups and the medication burden, based on number of medications, class and dose, was numerically higher in the sham group (7.6 vs. 10.3; P = .26).
For the new analyses according to time spent in therapeutic range through 3 years, researchers observed a “continued divergence” between groups in time spent in target range favoring renal denervation therapy at all time points.
“Moreover, according to ambulatory BP, once again at all time points renal denervation therapy was superior to sham control except at 12 months, a time in which there was a significantly higher medication burden among controls,” Kandzari said.
Kandzari said study participants who received renal denervation therapy experienced higher time spent in the target range compared with controls, both by office (P for systolic BP 140 mm Hg or less = .015) and ambulatory (P for systolic BP 140 mm Hg or less = .036; P for systolic BP 130 mm Hg or less = .03) measures and despite a similar number of medications.
“The greater stability of BP control after renal denervation therapy is supported by the observation of an ‘always-on’ effect with renal denervation therapy, differentiating it from the variabilities of drug pharmacokinetics, patient adherence and dosing regimens,” Kandzari said. “Upcoming [time in therapeutic range] analyses should focus on how these potential improvements with renal denervation therapy might translate into improved clinical outcomes.”
Real-world renal denervation benefits
Three-year data from the Global SYMPLICITY Registry show that radiofrequency renal denervation therapy was associated with a significant reduction in risk for MACE, as well as improvements in time spent in the recommended BP target range for up to 3 years, researchers reported.
As Healio previously reported, researchers found that renal denervation therapy contributed to sustained BP reductions out to 3 years without increasing medication burden. The Global SYMPLICITY Registry is the largest and longest study of real-world patients with uncontrolled hypertension treated with renal denervation, documenting long-term safety and effectiveness of the Symplicity renal denervation system.
“These results are not only focusing on the efficacy of the [renal denervation] procedure, but also the long-term safety,” Mahfoud said during a presentation of the findings. “However, whether this is linked to improved outcomes has not been shown or investigated. The database was just not large enough to look into hard clinical outcomes.”
Researchers estimated the impact of the proportion of time spent in the recommended target BP range on MACE, defined as CV death, MI or stroke for 3,077 patients enrolled in the Global SYMPLICITY Registry (mean age, 60 years; 42.2% women). Baseline office systolic BP was 166 mm Hg and mean baseline 24-hour systolic BP was 154 mm Hg. Time in therapeutic range from baseline to 6 months was used to inform a logistic regression model to predict how the measure affects MACE between 6 and 36 months.
“The patient population here is quite different from the randomized, sham-controlled trials,” Mahfoud said. “This is a real-world registry and physicians around the world struggled with these patients to get their BP controlled.”
Researchers observed a progressive decrease in BP after renal denervation, reaching a mean of –16.7 mm Hg for office-measured systolic BP and –9 mm Hg for 24-hour ambulatory systolic BP.
The rate of MACE was significantly different for patients who spent no time in the recommended BP range vs. those who spent at least 50% of time in range (10.3% vs. 2.9%; P < .0001). Rates of the individual components of MACE also favored those who spent at least 50% of time in range compared with those who had no time in range (CV death, 4% vs. 1.5%; P = .016; MI, 2% vs. 0.8%; P = .03; stroke, 5.4% vs. 0.1%; P < .0001).
Researchers found that each 10% increase in time spent in the target range during the first 12 months was associated with a 16% decrease in MACE in the proceeding 6 to 36 months, with an HR of 0.84 (95% CI, 0.79-0.9; P < .001).
“We showed here, for the first time, that patients after radiofrequency renal denervation who spent a greater amount of time in target BP range had fewer CV events, including stroke, MI and CV death,” Mahfoud said. “Of course, we do not have a control group for this study, but it is encouraging and may translate into significant improvements in outcomes in the high-risk individuals with hypertension.”
Benefits of ultrasound renal denervation
Data from two prospective studies assessing ultrasound renal denervation in patients with drug-resistant hypertension and mild to moderate hypertension showed there was no heterogeneity in effect on BP reduction and medication burden, researchers reported.
Pooled results from the prospective RADIANCE-HTN SOLO and RADIANCE-HTN TRIO studies favored ultrasound renal denervation over the sham population, with data suggesting the response to ultrasound renal denervation is similar in the presence or absence of medications and consistent across the whole spectrum of hypertension, Michel Azizi, MD, PhD, professor of vascular medicine at Georges Pompidou Hospital in Paris, said during a press conference.
“Ultrasound renal denervation, which is the other methodology used for renal nerve ablation, has been shown to reduce BP in patients with mild to moderate hypertension as well as resistant hypertension,” Azizi said. “The objective of this analysis was to evaluate pooled patient-level data outcomes with two prospectively powered studies, focused on reduction in BP and reduction in medication burden.”
For the blinded, randomized, sham-controlled RADIANCE-HTN trials, researchers evaluated the BP-lowering effect of the Paradise (ReCor Medical) renal denervation system in two patient populations: those with essential hypertension using up to two antihypertensive medications (SOLO) and those with treatment-resistant hypertension using at least three antihypertensive medications (TRIO). Participants were randomly assigned to the renal denervation procedure (n = 143) or to a sham procedure (n = 139). The primary efficacy endpoint was change in daytime ambulatory systolic BP.
At 6 months, the between-group difference favoring ultrasound renal denervation over sham was –4.8 mm Hg in daytime ambulatory systolic BP (95% CI, –7.1 to –2.5; P < .001) and –5.4 mm Hg for home systolic BP (95% CI, –7.3 to –3.6; P < .001). There was no heterogeneity in effect on the reduction in BP or the reduction in medication burden.
“When studying two independent cohorts of patients ... we want to observe if the treatment effect of a therapy is consistent or different,” Ajay J. Kirtane, MD, SM, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center, said during a presentation of the findings. “What we showed is that, at 6 months, the results were remarkably consistent, irrespective of the severity of hypertension. In showing this, we demonstrate that the response to ultrasound renal denervation is consistent across differing severities of hypertension.”
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Kandzari DE, et al. Hypertension management in 2022: Control it, live longer. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).
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