(Press-News.org) WASHINGTON (March 29, 2014) — Renal denervation fell short of primary and secondary efficacy goals in patients with severe resistant hypertension but did meet the primary safety endpoints, according to keenly awaited data from SYMPLICITY HTN-3 presented at the American College of Cardiology's 63rd Annual Scientific Session. This pivotal trial is the largest study conducted of renal artery denervation as a treatment for resistant hypertension and the most rigorously designed, including blinding and a sham treatment in the control arm.
Hypertension increases risks for heart attack and stroke for more than 77 million Americans and up to one billion adults worldwide. People with severe resistant hypertension – high blood pressure not controlled with three classes of medications – are a very challenging subset of patients. During the renal denervation procedure with the Symplicity device used in this trial, a catheter is threaded through arteries to deliver radiofrequency energy that inactivates kidney nerves, interrupting electrical signals to and from the kidney, an organ that performs a major role in regulating blood pressure. Although renal denervation is in clinical use for uncontrolled hypertension in more than 80 countries, it is still considered an experimental approach in the United States.
This study randomly assigned 535 patients with resistant hypertension and systolic blood pressure of 160 mmHg or higher to renal denervation or angiography alone. Both groups remained on treatment regimens of three or more antihypertensive drugs, including a diuretic, at the highest tolerated doses. Renal denervation failed to achieve the primary efficacy endpoint of a decrease in systolic blood pressure measured in the doctor's office from baseline to six months or the powered secondary efficacy endpoint of decrease in average 24-hour levels by ambulatory blood pressure monitoring, which provides more reliable readings. Although both study groups showed a statistically significant decrease at six months compared with baseline (-14.1 mmHg for renal denervation compared to -11.7 mmHg for the sham treatment control), the difference of -2.29 mmHg in office systolic blood pressure between the two arms was not significant. Results were similar for change in 24-hour systolic blood pressure, with a non-significant difference between the two arms of -1.96 mmHg.
"That is a fascinating result because it highlights the importance of a properly done, rigorous randomized trial that is both blinded and sham controlled," said Deepak L. Bhatt, M.D., M.P.H., executive director of interventional cardiovascular programs, Brigham and Women's Hospital Heart and Vascular Center, professor of medicine at Harvard Medical School, and co-principal investigator. "This is the first blinded trial or sham controlled trial in the field of renal denervation. It seems that these factors really mattered. We saw no added treatment benefit of renal denervation for patients with severe resistant hypertension who were closely monitored and optimally treated with medications."
Bhatt commented on the value of the study's cooperation between interventional and non-interventional blood pressure doctors, which demonstrated that a "good proportion" of patients with resistant hypertension in this study responded to expert medical therapy. However, new treatment options are still needed for patients with uncontrolled high blood pressure, he said.
The major adverse event rate of 1.4 percent for renal denervation comfortably met the safety goal of 9.8 percent, compared with 0.3 percent in the sham treatment arm. Although a particular area of concern was potential renal stenosis, there was only one case in the renal denervation group and none in the sham group.
"The field has really exploded with several devices in clinical practice despite lack of compelling data to support their use. Now we have some definitive data with one device," Bhatt said. "However, we do think research in the field should continue, especially to see if renal denervation is useful in other areas, such as heart failure or with alternative approaches. We've shown renal artery denervation is very safe."
INFORMATION:
Medtronic, Inc. funded SYMPLICITY HTN-3 and provided research funding to Bhatt for the study.
This study will be simultaneously published online in the New England Journal of Medicine at the time of presentation.
The ACC's Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC14 for the latest news from the meeting.
The American College of Cardiology is a nonprofit medical society comprised of 47,000 physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College is dedicated to transforming cardiovascular care, improving heart health and advancing quality improvement, patient-centered care, payment innovation and professionalism. The ACC also leads the formulation of important cardiovascular health policy, standards and guidelines. It bestows credentials upon cardiovascular specialists, provides professional education, supports and disseminates cardiovascular research, and operates national registries to measure and promote quality care. For more information, visit CardioSource.org.
Renal denervation shows no benefit in resistant hypertension
Strong effects seen in earlier trials disappear with rigorous design of SYMPLICITY HTN-3
2014-03-31
ELSE PRESS RELEASES FROM THIS DATE:
Efforts to curb hospital readmissions take center stage
2014-03-31
WASHINGTON (March 29, 2014) — Strategies aimed at reducing the number of patients with heart failure and other cardiovascular conditions who find themselves back in the hospital after discharge were identified in six new studies presented at the American College of Cardiology's 63rd Annual Scientific Session.
One out of five Medicare patients with heart failure is readmitted to the hospital within just one month of discharge, a fact that is not only bad news for patients who would most likely prefer to avoid another hospital stay, but it also places intense economic pressures ...
Primary cardiovascular disease prevention is leaving the office
2014-03-31
MINNEAPOLIS, MN – March 30, 2014 – Early results from HeartBeat Connections, a telemedicine program supported by the Minneapolis Heart Institute Foundation (MHIF), suggest effective primary prevention for cardiovascular disease (CVD) may be achieved with a team-based approach that integrates office visits with supplemental phone coaching. HeartBeat Connections provides dietitian- and nurse-led coaching over the phone to adults at high risk for CVD, with the goal of helping to improve and control key CVD risk factors. Gretchen Benson, RD, CDE, Healthcare Systems Integration ...
Adults with inherited high cholesterol are underdiagnosed and undertreated
2014-03-31
MINNEAPOLIS, MN – March 30, 2014 – An estimated 1 in 500 people worldwide suffer from familial hypercholesterolaemia (FH), an inherited condition of extremely high cholesterol that is associated with premature heart disease and death. Despite this high prevalence, recent research funded by the Minneapolis Heart Institute Foundation (MHIF) confirms FH is underdiagnosed and undertreated. Thomas Knickelbine, MD, Preventive Cardiology Director at the Minneapolis Heart Institute at Abbott Northwestern Hospital, will present the results of research aimed at identifying just ...
Evolocumab superior to ezetimibe in lowering LDL cholesterol
2014-03-31
WASHINGTON (March 30, 2014) — Evolocumab, an injected form of a class of drugs called PCSK9 inhibitors that lower low-density lipoprotein cholesterol, also known as LDL-C or "bad cholesterol," outperformed ezetimibe with few side effects in patients unable to take statins, according to research from GAUSS-2 presented at the American College of Cardiology's 63rd Annual Scientific Session.
High LDL cholesterol is considered a major risk factor for cardiovascular disease. Statins are commonly prescribed to reduce that risk. Currently ezetimibe is one of the few options ...
Head-to-head study favors balloon-expandable transcatheter heart valves
2014-03-31
WASHINGTON (March 30, 2014) — A first-ever randomized head-to-head comparison of two devices commonly used to treat the age-related disease aortic stenosis finds balloon-expandable transcatheter valves result in more successful procedures and relieve symptoms more frequently than self-expanding valves, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.
Aortic stenosis is a condition in which a crucial valve in the heart ceases to function properly. The only cure is to replace the valve, either through open heart surgery ...
Higher risks without cardio benefits halt study of aleglitazar
2014-03-31
WASHINGTON (March 30, 2014) — The phase III AleCardio trial was ended early when patients with type 2 diabetes and recent acute coronary syndrome who were treated with aleglitazar showed higher rates of heart failure, kidney events and gastrointestinal bleeding with no offsetting cardiovascular benefits, according to data presented at the American College of Cardiology's 63rd Annual Scientific Session. All other studies with the drug have been stopped as well.
Aleglitazar sparked interest for this patient population because of its dual action on two subtypes of the PPAR ...
Darapladib falls short in chronic coronary heart disease
2014-03-31
WASHINGTON (March 30, 2014) — The novel inflammation inhibitor darapladib showed no primary-endpoint advantage over placebo in patients with chronic coronary heart disease treated with a high level of background care, although it did suggest possible benefits for more specific coronary artery-related endpoints, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session. STABILITY is the first study to test this inflammation-prevention mechanism for reducing the likelihood that plaque will become an artery-blocking clot.
Darapladib ...
Evolocumab safely drops LDL cholesterol well below statin-only baseline
2014-03-31
WASHINGTON (March 30, 2014) — The monoclonal antibody evolocumab produced highly significant reductions in low-density lipoprotein (LDL) cholesterol, the "bad cholesterol," as an add-on to statins in all treatment groups, according to data from the LAPLACE-2 study presented at the American College of Cardiology's 63rd Annual Scientific Session.
LDL cholesterol is considered a major risk factor for cardiovascular disease. "High-risk patients – such as those with clinical cardiovascular disease, high LDL cholesterol levels or diabetes – are ideally treated with high-intensity ...
Anti-gout medication colchicine helps patients with recurrent pericarditis
2014-03-31
WASHINGTON (March 30, 2014) — A medication traditionally used to treat gout is also effective at treating recurrent pericarditis, an inflammation of the sac-like covering around the heart, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.
In the first multicenter, double-blind trial to look at the use of colchicine for multiple recurrences of pericarditis, 240 patients were randomly assigned to either the study drug or placebo to examine the primary endpoint of recurrent pericarditis. The rate of disease recurrence ...
Renal denervation patient registry finds low rate of adverse events
2014-03-31
WASHINGTON (March 30, 2014) — Patients with uncontrolled high blood pressure treated with renal denervation had low rates of adverse events and significant lowering of blood pressure at six months, according to a registry-based study presented at the American College of Cardiology's 63rd Annual Scientific Session.
The Global SYMPLICITY Registry is the first and largest dataset of patients with uncontrolled hypertension treated with renal denervation. The open-label, multicenter study was established to examine the safety and effectiveness of the procedure. Outcomes presented ...
LAST 30 PRESS RELEASES:
Animated movie characters with strabismus are more likely to be villains, study finds
How retailers change ordering strategy when a supplier starts its own direct channel
Young coral use metabolic tricks to resist bleaching
Protecting tax whistleblowers pays off
Bioluminescent proteins made from scratch enable non-invasive, multi-functional biological imaging
New study links air pollution with higher rates of head and neck cancer
LSU researchers excavate earliest ancient Maya salt works
Building a diverse wildland fire workforce to meet future challenges
MBARI researchers discover remarkable new swimming sea slug in the deep sea
Decentralized social media ‘increases citizen empowerment’, says Oxford study
Validating an electronic frailty index in a national health system
Combination approach shows promise for treating rare, aggressive cancers
Raise the roof: How to reduce badminton birdie drift
Ouch! Commonalties found in pain vocalizations and interjections across cultures
Income-related disparities in mortality among young adults with type 2 diabetes
Medical board discipline of physicians for spreading medical misinformation
First-ever randomized clinical trial uses telehealth for suicide prevention
DNA packaging directly affects how fast DNA is copied in cells
Scientists develop advanced catalyst for self-driven seawater splitting with enhanced chloride resistance
City of Hope researchers discover why taking a mushroom supplement slows or prevents prostate cancer from getting worse
Montefiore Einstein’s Marina Konopleva joins Break Through Cancer TeamLab in fight against acute myelogenous leukemia
Early treatment for nerve tumors prevents serious problems, study finds
Study: Student absenteeism crisis may be hurting teacher job satisfaction
Medicaid enrollment continuity tied to lymphoma stage at diagnosis
INSEAD launches free Negotiation Course for the World
Wyss Institute’s iNodes team receives ARPA-H Sprint for Women’s Health award to advance the first implantable immune organs to treat ovarian cancer
Goblet cells could be the guardians of the gut
Romania’s science journalists join forces on new reporting handbook
SwRI-led team proposes new solar composition ratios that could reconcile longstanding questions
Sodium butyrate inhibits necroptosis by regulating MLKL via E2F1 in intestinal epithelial cells of liver cirrhosis
[Press-News.org] Renal denervation shows no benefit in resistant hypertensionStrong effects seen in earlier trials disappear with rigorous design of SYMPLICITY HTN-3