Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension, complementing existing first-line treatments including lifestyle modifications and medication, attendees of the conference heard.
Day one of the four-day international interventional cardiology meeting, which has returned to an in-person format in Paris for the first time since 2019, saw the release of data from three clinical studies assessing the use of renal denervation as a treatment for hypertension—the Global Symplicity Registry, SPYRAL HTN-ON MED and an analysis of ultrasound renal denervation from the RADIANCE HTN SOLO and TRIO trial cohorts.
Speaking in a press conference ahead of the presentation of the data, Felix Mahfoud (Saarland University Hospital, Hamburg, Germany) told attendees that renal denervation represents a device-based treatment option to tackle the problem of hypertension.
“Despite all advances in care we still have a significant proportion [of patients] that are either undiagnosed or not sufficiently controlled to target blood pressure, and that holds true for almost all regions and geographies around the world,” he told assembled press, pointing out that the release of the data also coincides with the 2022 World Hypertension Day, which carries an aim to communicate to the public the importance of hypertension and its serious medical complications, and to provide information on prevention, detection and treatment.
“We know from large meta analyses and prospective randomised clinical trials that reducing blood pressure is impactful for patients,” he added. “The problem is not that we do not know that blood pressure is an issue and is serious, the problem is that we have available drugs that work quite well but patients do not like them and patients do not take them.
“There is obviously an unmet need, and renal denervation represents a device-based treatment option to tackle that problem,” he said.
Mahfoud then previewed data to be released later in the day during a hot-line session at EuroPCR, the three-year Global Symplicity Registry results, assessing blood pressure and major adverse cardiovascular events (MACE) after renal denervation using Medtronic’s Symplicity system.
The results show that a 10% time in target range increase in the first 12 months reduces the odds of MACE events in the following 24 months and led to the conclusion that sustained blood pressure reduction after renal denervation predicts a meaningful reduction in clinical events. In this large, global registry, which involved 3,077 patients, those who underwent radiofrequency renal denervation spent a greater amount of time in target blood pressure range and had less cardiovascular events including cardiovascular death, myocardial infarction, and stroke.
The presenter commented that, though the data come with some limitations, they are “encouraging” and show for the first time patients with a higher time in target range have reduced events. “That should convince people that lowering blood pressure with renal denervation translates into improved outcomes,” he remarked.
Also presenting data during the same EuroPCR session, David Kandzari (Piedmont Heart Institute, Atlanta, USA) offered three-year data from the SPYRAL HTN-ON MED trial, investigating Medtronic’s Symplicity Spyral renal denervation system, giving an overview of the impact of renal denervation on long-term time in target blood pressure range compared with sham control.
Time in target therapeutic range has become an established and validated measure of control for chronic disease conditions, Kandzari said in his presentation, adding that specific to hypertension, time in target range is an independent measure of blood pressure control and is an independent predictor of cardiovascular events.
Kandzari noted that early results from the pilot study showed that patients who underwent renal denervation while on antihypertensive medications had lower blood pressure when compared to the sham control group, the effect of renal denervation on blood pressure burden over time had not been established.
With this latest report, a time in target therapeutic range analysis was performed using data comparing the two groups over three years and showed that the renal denervation and AH group had significantly higher time in target therapeutic range with more time in the blood pressure target range at two and through to three years as compared to the sham group, thus affirming the sustained efficacy of renal denervation over late-term follow-up.
Also presenting alongside Mahfoud and Kandzari, Ajay Kirtane (Columbia University Irving Medical Center/NewYork Presbyterian Hospital, New York, USA) offered findings of a patient-level pooled analysis of ultrasound renal denervation in the RADIANCE HTN SOLO and TRIO trials.
The analysis examined data tracking the use of ultrasound renal denervation using the Paradise (Recor Medical) system in a drug resistant population (three years or more of antihypertensive medications) taken from the RADIANCE-HTN TRIO study, and from RADIANCE-HTN SOLO, in a population with mild to moderate hypertension (controlled on 1-2 antihypertensive medications or uncontrolled on 0-2 medications).
The results of the analysis showed that there was no heterogeneity in effect on blood pressure reduction and medication burden. Those results looking at a mixed population over a six-month period favoured ultrasound renal denervation over the sham population and the pooled analysis of the RADIANCE-HTN trials suggests “the response to ultrasound renal denervation is similar in the presence or absence of medications and consistent across the whole spectrum of hypertension.”
