SYMPLICITY HTN-3 Trial Data Shows Sustained Reductions in Blood Pressure with Medtronic Renal Denervation Procedure

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  • Long-term analysis of a landmark renal denervation trial presented as Late Breaking Clinical Science, published concurrently in The Lancet
  • The data adds to a growing body of evidence supporting the durability of the Symplicity blood pressure procedure

DUBLIN and BOSTON, September 18, 2022 /CNW/ – Medtronic plc (NYSE: MDT), a global health technology leader, today announced long-term results from the SYMPLICITY HTN-3 clinical trial. Subjects who underwent radiofrequency renal denervation (RF RDN) with the first-generation Symplicity™ Renal Denervation System experienced a statistically significant reduction in office and ambulatory blood pressure compared to subjects in the sham control group. The data was presented today under the title Late-Breaking Clinical Science at the 34e Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published concurrently in The Lancet.

“In this long-term follow-up of the SYMPLICITY HTN-3 trial, we observed significant reductions in blood pressure in patients who underwent renal denervation therapy, with no long-term complications resulting from this minimally invasive procedure,” said Deepak L. BhattMD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School; and Co-Principal Investigator of the SYMPLICITY HTN-3 trial. “These results provide important insights into the evolution of patients’ blood pressure control, with and without renal denervation, in a scenario closer to the real world – under the daily management of a physician without the frequent follow-up visits and monitoring that occur in research The results illustrate that for some patients with high blood pressure, despite attempts to adhere to multiple medications and make lifestyle changes, their blood pressure remains poorly controlled, putting them at risk at risk of cardiovascular complications such as stroke.

A total of 535 patients with treatment-resistant hypertension were randomized in a 2:1 ratio between RDN (n=364) and sham control (n=171). After six months, 101 patients from the sham control group were treated with RDN (crossover group). When performing a longer-term analysis with all available data and accounting for control crossover patients using their last observation carried forward (imputation), the three-year results are as follows:

  • 26.4 mm Hg reduction in systolic blood pressure (OSBP) in the office for the RDN group (n = 219) versus a 5.7 mm Hg reduction in OSBP for the sham control group (n = 134; difference adjusted treatment time: 22.1 mm Hg, p
  • 15.6 mm Hg reduction in ambulatory systolic blood pressure (ASBP) over 24 hours for the RDN group (n=152) and -0.3 mm Hg reduction in ASBP over 24 hours for the sham control group (n=119); adjusted treatment difference: 16.5 mm Hg, p
  • On average, 17.5% of RDN patients spent time in target range (TTR), a cumulative measure in which blood pressure measurements are estimated over time, compared to 8.2% of TTR for sham patients (p
  • Medtronic Symplicity Blood Pressure Procedure1 demonstrated long-term safety consistent with expected outcomes for this patient population.2

In 2014, Medtronic announced that after six months, the HTN-3 trial met its primary safety endpoint, but failed to meet its primary or secondary efficacy endpoints due to multiple confounding factors, including the influence of medication changes, specific patient subgroups and procedural factors. . This latest analysis from the SYMPLICITY HTN-3 trial examined the long-term safety and effectiveness of RDN in hypertensive patients who were taking antihypertensive medications and receiving treatment with the Symplicity Blood Pressure Procedure. This included patients in the sham control arm who switched to RDN after the initial six-month primary endpoint analysis.

“Although we did not find a significant difference in blood pressure reduction over six months between RDN and sham in HTN-3, we felt there was much to learn by following HTN-3 patients for a longer period, especially in sham patients with sustained elevations in blood pressure who ‘crossed’ to RDN,” said Jeffrey Popma, MD, medical director of coronary and renal denervation activities and structural activity of the heart and aorta, which are part of Medtronic’s cardiovascular portfolio. “Using standard imputation methods for blood pressure comparison in crossover patients, we were delighted to see a sustained benefit in blood pressure reduction over three years in HTN-3 patients treated with RDN. This study adds important additional information to the total body of evidence now supporting the long-term effect of RDN in patients with hypertension Documentation of medication adherence and improvements to the new Spyral catheter may have the potential to further influence clinical outcomes in patients enrolled in the SPYRAL study portfolio.

“Combined, with over 7,000 patients published in clinical studies, we now have a better understanding of patient behavior and long-term RDN impacts,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, part of Medtronic’s cardiovascular portfolio. “This analysis adds to the extensive long-term spurious evidence of the Symplicity blood pressure procedure which has consistently shown a positive impact for patients, both in the absence and in the presence of medication. We remain deeply committed to this complementary treatment option for hypertension and we look forward to data from additional studies, including the SPYRAL HTN-ON MED extension trial, which we plan to have at the American Heart Association Scientific Sessions , subject to acceptance.”

Approved for commercial use in more than 60 countries worldwide, the Symplicity Spyral Renal Denervation System is limited to investigational use in United States, Japanand Canada.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the global health technology leader boldly tackling the toughest health challenges facing humanity by researching and finding solutions. Our mission – to relieve pain, restore health and extend life – unites a global team of more than 95,000 passionate people in 150 countries. Our technologies and therapies address 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With our diverse knowledge, insatiable curiosity and desire to help everyone in need, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we deliver insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we design the extraordinary. For more information about Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 The study used the first-generation Symplicity system, which included a single-electrode catheter
2 Bhatt et al. A controlled trial of renal denervation for resistant hypertension. The New England Journal of Medicine. 2014 Mar 29. 2014;370:1393-401.

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