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BOSTON -- Endovascular renal denervation (RDN) continued to lower blood pressure (BP) in different populations regardless of the specific technology used, according to two late-breaking trial presentations here at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation.

First, the RADIANCE II pivotal trial confirmed a modest effectiveness at BP lowering with ultrasound-based RDN over a sham procedure in people with uncontrolled hypertension taken briefly off their antihypertensive medications, reported Ajay Kirtane, MD, SM, of New York-Presbyterian/Columbia University Irving Medical Center in New York City.

At 2 months, there was a significant -6.3 mm Hg improvement in daytime ambulatory systolic BP (-7.9 vs -1.8 mm Hg, P<0.0001) accompanied by reductions in 24-hour, nighttime, home, and office systolic BP.

RADIANCE II

BP results with the Paradise device thus align with previous findings in the mild-to-moderate off-medicine hypertension cohort in RADIANCE-HTN SOLO and the patients with resistant hypertension in RADIANCE-HTN TRIO.

"We should not forget that this is the sixth randomized sham-controlled trial to confirm the efficacy of this approach across different modalities and different patient populations," said session panelist Felix Mahfoud, MD, of Saarland University Medical Center in Germany.

Kirtane stressed that in clinical practice, people should try medical therapy and lifestyle modification before RDN if it eventually gets approved for treating hypertension. Before reaching that point, however, RDN still needs additional data on safety and clinical outcomes, he said.

RADIANCE II included 224 people who were taken off their BP medications and had daytime ambulatory BP stay in the 135/80 to 170/105 mm Hg range. They were randomized 2:1 to RDN or sham and allowed no medications unless they met high home or office BP criteria.

There was no change in eGFR at 2 months in either group, and zero adverse events at 30 days or 6 months.

Adverse events will likely eventually accrue, given that RDN is an invasive procedure, Kirtane cautioned.

He noted that his group is still looking for a way to preemptively identify responders and nonresponders to RDN therapy. Forthcoming analyses will evaluate what happens to BP in patients who have medications added back after 2 months, he said.

Another TCT panelist, Naomi Fisher, MD, of Brigham and Women's Hospital and Harvard Medical School in Boston, emphasized the urgency of finding new ways to reduce BP around the world.

"We need innovation. Our control rates are poor and only falling," she said. "Our last new drug class [for hypertension] was introduced in 2007. That's how long [since] we've had innovation."

SYMPLICITY HTN-3 Revisited

After negative initial data from the main SYMPLICITY HTN-3 analysis, first-generation radiofrequency RDN with the Symplicity Flex catheter found some redemption, in line with more contemporary findings supporting a newer system for modest BP lowering.

Observed change in office systolic BP at 3 years was -22.1 mm Hg (-26.4 mm Hg with RDN vs -5.7 mm Hg without RDN, P<0.0001), an improvement from the difference of -13.4 mm Hg at 12 months (-18.9 vs -6.3 mm Hg, P<0.0001).

This was observed after participants on maximal medical therapy had been unblinded at 6 months and controls were allowed to cross over to RDN, according to the trial's final follow-up data presented by Deepak Bhatt, MD, MPH, also of Brigham and Women's Hospital and Harvard Medical School. These results were simultaneously published in .

Similar findings were seen in office diastolic BP and 24-hour systolic and diastolic BP, and the proportion of the RDN group with systolic BP over 160 mm Hg fell from 100% at baseline to 57% at 6 months and 32% at 36 months.

Mahfoud suggested a resetting of the baroreflex sensors as an explanation for the perceived magnification of effect with RDN over time. However, Bhatt cautioned that it may also be related to the sham group behaving the best they ever will during the blinded trial phase, but not adhering to medications once the real-world phase of the study kicks in.

The present analysis included 535 people not responding to at least three antihypertensive medications. The investigators relied on imputation and other statistical techniques to account for the unblinding, dropouts, and crossovers of patients over time.

Correction: This article previously included an erroneous mention of LDL cholesterol lowering. It has been updated to correct this.