New RADIANCE data: ‘Durable’ BP lowering, fewer meds after ultrasound renal denervation
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Key takeaways:
- Pooled data from three ultrasound renal denervation studies showed reductions in BP vs. a sham procedure after factoring in medications.
- Data also showed consistency across a spectrum of hypertension severity.
SAN FRANCISCO — A new pooled analysis showed a maintained BP-lowering effect with fewer added medications after treatment with an ultrasound renal denervation system compared with a sham procedure, a speaker reported at TCT 2023.
Data show ultrasound renal denervation (Paradise, ReCor) lowered BP at 2 months for adults with both mild to moderate and resistant hypertension in the sham-controlled RADIANCE II, RADIANCE HTN-SOLO and RADIANCE HTN-TRIO trials, Ajay Kirtane, MD, SM, director of Columbia Interventional Cardiovascular Care, said during a presentation. In a new individual patient-data pooled analysis, researchers assessed the 6-month effectiveness and safety of ultrasound renal denervation vs. sham in conjunction with escalating medical therapy for hypertension control.
“Between 2 to 6 months, we see reductions in BP in both the denervation and sham groups, and that is because we told the trial investigators that they really had to try to control patients’ BP [with medications], especially patients in the sham arm had been uncontrolled for 3 months,” Kirtane told Healio. “We know that with aggressive BP management, you can lower BP with medications. But what we were happy to see was that even with increasing medications [in both arms], the background the effect of denervation persisted. BPs were numerically lower among those who had denervation and also, the group who had sham had more medicines added. That means denervation had a residual effect and that it is durable.”
Benefit after factoring in medications
Kirtane, Michel Azizi, MD, PhD, professor of vascular medicine at Georges Pompidou Hospital in Paris, and colleagues analyzed data from patients with mild to moderate hypertension not taking antihypertensive medications or with resistant hypertension randomly assigned to undergo ultrasound renal denervation (n = 293) or a sham procedure (n = 213). Across cohorts, the mean baseline age was 54 years, 70% were men and mean baseline daytime ambulatory systolic BP was 150 mm Hg. All three trials had a medication stabilization regimen before randomization, Kirtane said, with participants in RADIANCE II and SOLO going off BP medications 1 month before denervation and participants in TRIO stabilized with a single triple-therapy combination pill.
“The reason for that is that we wanted to make sure we were isolating the effect of denervation from sham,” Kirtane said during a press conference.
Participants in both groups were asked to remain without added antihypertensive therapies during 2 months of follow-up unless exceeding specific BP criteria of 135/85 mm Hg.
If monthly home BP was 135/85 mm Hg from 2 to 5 months, antihypertensive therapies were sequentially added to a target home BP of 136/85 mm Hg, while still blinded to the initial treatment assignment.
The findings were simultaneously published in Circulation.
Researchers found that BP decreased in both groups from 2 to 6 months with titration of antihypertensive medications; however, fewer patients in the ultrasound renal denervation groups were prescribed BP medications compared with sham (P = .004) and fewer additional BP medications were prescribed to patients in the ultrasound renal denervation group (P = .001).
“Notably, both groups had medications added, so it is not like you are going to control everyone with renal denervation, you’re typically going to need medications to control BP,” Kirtane said.
At 6 months, the unadjusted between-group difference in daytime ambulatory systolic BP was similar at 6 months; however, the baseline and medication-adjusted between-group difference at 6 months was –3 mm Hg (95% CI, –5.7 to –0.2; P = .033) in favor of ultrasound renal denervation plus antihypertensive medications. For home and office systolic BP, the adjusted between-group differences in favor of ultrasound renal denervation plus antihypertensive medications over 6 months were –5.4 mm Hg (95% CI, –6.8 to –4; P < .001) and –5.2 mm Hg (95% CI, –7.1 to –3.3; P < .001), respectively.
There was no heterogeneity between trials, Kirtane said, and safety outcomes did not differ between the groups.
Need for new options
“You can get this level [of BP lowering] with medications, but medicines have to be successfully implemented,” Kirtane told Healio. “That is where renal denervation fits in. It is adherence independent. You do not have to take medicine every day. But that does not mean you shouldn’t try.”
During a Q&A session after the press conference, Kirtane addressed critiques about the amount of BP lowering seen with renal denervation and the durability of the BP lowering effect.
Kirtane said renal denervation is not intended to replace medical therapy, although some patients will experience a more profound BP benefit than others.
“I would characterize the effect of renal denervation overall, especially when compared to medications, as a moderate effect,” Kirtane said. “But I would also say that there are so many medications and lifestyle modifications available; yet, we have rates of control in the United States and worldwide of about 60%. With [renal denervation], you want a patient to come in, be assessed, try all of the [options] we would normally try. If those still fail, at that point, denervation might be considered.”
As Healio previously reported, an FDA advisory panel in August voted 10-2 that the benefits of the Paradise system outweigh any risks for use in adults with uncontrolled hypertension who are unresponsive or intolerant to antihypertensive medications and voted unanimously that the device is safe for use. An FDA decision on approval is expected in 2023.
Reference:
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Kirtane A, et al. Late-breaking clinical science: Session III, in collaboration with European Heart Journal/EuroIntervention. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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