Marking World Hypertension Day: Data of three renal denervation trials point it to be effective long-term treatment of hypertension
Paris, France: World Hypertension Day whose theme "Measure Your Blood Pressure Accurately, Control It, Live Longer" is aimed at increasing awareness of hypertension worldwide. Besides awareness, effective control of hypertension remains low in the general population. At EuroPCR 2022, the Global SYMPLICTY Registry and 3 ongoing trials-SPYRAL-HTN ON MED, RADIANCE-HTN SOLO and TRIO-will further focus on expanding experience in effective device-based treatments for hypertension using renal denervation.
The management of hypertension in 2022 remains of critical concern. Despite the intervening years and the array of safe and effective treatments available, mainly antihypertensive drugs and lifestyle modification, adherence continues to be a serious problem with an inestimable burden on the patient and healthcare systems worldwide. "Hypertension can be easily diagnosed and treated but it is often undiagnosed and left untreated." says Professor Felix Mahfoud from Saarland University Hospital in Germany.
In an effort to combat "low awareness rates", the theme of World Hypertension Day this year is to "Measure Your Blood Pressure Accurately, Control It, Live Longer" with the conviction that "accurate blood pressure measurement methods" is one way towards a better public understanding, increasing both the recognition of the disease and adherence to treatment once hypertension has been diagnosed.
Concurrently, the development of effective device-based treatments for hypertension using renal denervation (RDN) which have been under study with numerous trials and registries for well over a decade now are bearing fruit, and because of this, today interest in RDN remains justifiably high. Research continues, devices and techniques evolve, and emerging data helps refine the approach and widen its adoption.
At EuroPCR 2022 presentation of data and results from the global SYMPLICTY Registry and 3 ongoing trials: SPYRAL-HTN ON MED, RADIANCE-HTN SOLO and TRIO will encourage this momentum, supporting the efficacy and safety of RDN.
Blood pressure and MACE reductions after renal denervation: 3-year GSR results
Professor Felix Mahfoud presents the 3-year results from the Global SYMPLICTY Registry. This global study was designed to assess the safety and efficacy of RDN for real world patients with uncontrolled hypertension, looking as well at the impact of long-term blood pressure reduction after RDN on reducing clinical events related to hypertension. Using a "Time in Target Range" (TTR) analysis, the authors were able to estimate the proportion of time that a patient achieves an ideal blood pressure, estimating the impact this has on MACE (death, myocardial infarction, or stroke). The results show that a 10% TTR 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 RDN predicts a meaningful reduction in clinical events. In this large, global registry, patients after radio-frequency RDN spent a greater amount of time in target blood pressure range and had less cardiovascular events including cardiovascular death, myocardial infarction, and stroke.
Renal denervation increases TTR Blood Pressure range
Professor David E. Kandzari will present 3-year data from the SPYRAL-HTN ON MED trial. While early results from the pilot study showed that patients who underwent RDN while on antihypertensive medications had lower blood pressure when compared to the sham control group, the effect of RDN on blood pressure burden over time had not been established.
With this latest report, a TTR analysis was performed using data comparing the two groups over 3 years and showed that the RDN and AH group had significantly higher TTR with more time in the blood pressure target range at 2 and through to 3 years as compared to the sham group, thus affirming the sustained efficacy of RDN over late-term follow-up.
Measuring the response to ultrasound RDN in the presence or absence of medications
RADIANCE-HTN SOLO and TRIO, presented by Professor Ajay J. Kirtane examines data from the RADIANCE-HTN TRIO study in which ultrasound RDN was used in a drug resistant population (3+ antihypertensive medications) and 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 6-month period favoured ultrasound RDN over the sham population and the pooled analysis of the RADIANCE-HTN trials suggests "the response to ultrasound RDN is similar in the presence or absence of medications and consistent across the whole spectrum of hypertension."
The future is now
In the October 2012 edition of EuroIntervention, Jean Fajadet, then President of the EAPCI, wrote that "catheter-based renal sympathetic denervation for the treatment of resistant hypertension" offered a unique opportunity, and that further research will provide the necessary "long-term data", that "specialists need to be informed and educated. Selection of patients and the understanding of the limits and impact of renal denervation must be fully considered".
In the 2018 PCR position statement, questions remained as to whether the proven blood pressurelowering effects of RDN were sustainable at long-term follow-up. Current research presented here has come a long way to answering in the affirmative, that RDN is an effective answer to the ongoing challenge of treating hypertension worldwide.
Emerging long-term data is positive and today, World Hypertension Day, the promise of an effective treatment using RDN is more than welcome as we begin to tackle the challenge of adherence-and indifference-to a serious disease that is a burden to both individuals and the societies they live in.
