News | December 06, 2013

Three-Year Results From SYMPLICITY HTN-2 Shows Significant and Sustained Drops in Blood Pressure Renal Denervation

Longest-term data from the first randomized, controlled trial of renal denervation presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium

December 6, 2013 – Medtronic, Inc. presented three-year data from SYMPLICITY HTN-2, the first and longest-running randomized, controlled clinical trial of renal denervation, which continue to demonstrate results consistent with data reported previously at six, 12 and 24-months of follow-up. The data were presented for the first time during an oral abstract session on Tuesday, October 29, 2013 at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium taking place this week in San Francisco. The Symplicity renal denervation system is available for investigational use only in the United States.

“As the first and longest-term experience in a randomized, controlled setting, these data mark a significant milestone for the renal denervation clinical community, as well as the single-electrode Symplicity system,” said Robert J. Whitbourn, M.B.B.S., M.D., associate professor and director of the Cardiovascular Research Centre at St. Vincent’s Hospital in Melbourne. “These results continue to demonstrate the impact renal denervation can have on patients with uncontrolled hypertension, and these data are an important contribution to the growing body of evidence supporting renal denervation with the Symplicity system as a therapy option for this underserved population.”

The data show an average blood pressure reduction of -33/-14 mm Hg [p<0.01] from baseline and an overall response rate (systolic blood pressure drop of greater than or equal to 10 mm Hg) of 85 percent for patients initially randomized to treatment with the Symplicity system and available for 36-month evaluation (n=40). Despite a mean systolic blood pressure of 183.5 ± 19.5 mm Hg pre-denervation, 50 percent of these patients achieved the goal of systolic blood pressure of <140 mm Hg. The safety profile of renal denervation with the Symplicity system was also maintained at three years, with no newly reported device or procedure related serious adverse events. None of the patients treated with the Symplicity system followed through three years required renal artery stenting.

In this trial, patients were required to have severe, uncontrolled hypertension with a systolic blood pressure greater than or equal to 160 mm Hg despite the use of three or more antihypertensive medications, including a diuretic. All patients were maintained on their usual antihypertensive medications and were randomly allocated in a one-to-one ratio to undergo renal denervation or no additional treatment (control group). At baseline, the randomized treatment and control patients had similar high blood pressures: 178/97 mm Hg and 178/98 mm Hg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. Patients in the control arm of the study were offered renal denervation following assessment of the trial’s primary endpoint at six months following randomization. This crossover treatment group experienced significant and sustained blood pressure reductions at 30 months after renal denervation with an average blood pressure reduction of –33/-13 mm Hg [p<0.01] from baseline (n=30).

The complete data was presented by Robert J. Whitbourn, M.B.B.S., M.D., during an oral abstract session titled Renal Denervation and Endovascular Intervention.

For more information: www.medtronic.com

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo