PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Bendavia does not reduce scarring from angioplasty after heart attack

First clinical trial shows drug is well-tolerated but reveals no significant benefits

2015-03-16
(Press-News.org) Patients who received the new drug Bendavia before undergoing angioplasty or receiving a stent to clear blocked arteries after a heart attack showed no significant reduction in scarring as compared to patients given a placebo, according to a study presented at the American College of Cardiology's 64th Annual Scientific Session.

The study is the first randomized, controlled trial of Bendavia, a drug designed to reduce the extent of tissue damage in the heart through a new approach that targets mitochondria in the cells. Although patients receiving the drug showed a 10 percent reduction in scarring during the first three days after surgery as measured by the levels of an enzyme called creatinine kinase-MB, the study's primary endpoint, the difference was not statistically significant. The results also suggested a trend toward improved heart pumping function during the eight hours following the drug's administration, but that trend also did not reach statistical significance.

"Our study found that the drug did not prevent irreversible injury to the heart," said C. Michael Gibson, M.D., professor of medicine at Harvard Medical School and the study's lead author. "However, we did see a trend for patients to have a reduced incidence of new onset heart failure in the first eight hours after the infusion, which may indicate that Bendavia could help improve heart pumping function for heart failure patients. This hypothesis-generating observation is being prospectively evaluated in an ongoing study."

A heart attack occurs when a blood clot blocks one of the heart's coronary arteries. Bendavia, which showed promise in animal studies, was developed to improve outcomes for patients who suffer a heart attack and undergo stenting and angioplasty, a procedure in which a surgeon threads a device through a vein in the groin or arm that is then inflated or expanded to open the artery and allow blood to flow through. Angioplasty is performed in more than one million people in the United States each year.

Patients who undergo angioplasty after a heart attack typically have permanent tissue damage and scarring in the heart, up to half of which can be attributed to the injury that occurs as a result of restoring blood flow in heart tissue that has been deprived of oxygen, a process called reperfusion injury. This damage causes the heart to work harder to pump blood and increases the likelihood of future heart failure.

Bendavia uses a new approach to reduce the extent of angioplasty-related injury and scarring by bolstering the cells' natural systems of energy production during the procedure. "The mitochondria--the powerhouse of the cell--is one of the key players in reperfusion injury," Gibson said. "The goal of Bendavia is to help the mitochondria stay functional and therefore to reduce the amount of tissue damage and injury."

Bendavia's activity in the mitochondria could also help it improve heart function for people with heart failure, a condition in which the heart muscle is so damaged that it cannot pump enough blood to keep up with the demands of the body.

"For patients with failing hearts, we currently give drugs that make the heart pump harder, increasing the demands on the heart," Gibson said. "By contrast, this drug aims to supply more energy to the cells to improve the supply side of the equation, which is a different approach."

The trial included nearly 300 patients at 24 hospitals in four countries who underwent angioplasty and stenting after ST-elevation myocardial infarction, the most severe type of heart attack. Half of the patients were randomly selected to receive a placebo and half received a dose of Bendavia starting at least 15 minutes before their procedure. The drug and placebo were infused via intravenous drip over the course of one hour.

The results fell short of statistical significance for all primary and secondary endpoints that were identified for the study, which included the size of the damaged heart tissue as measured by the creatinine kinase-MB enzyme for the first three days, as well as a variety of other common measures of heart tissue damage such as magnetic resonance imaging, troponin levels and ST-segment resolution.

The results also revealed no difference in clinical outcomes including congestive heart failure, subsequent hospitalization and death, and the drug was not associated with any adverse reactions or safety concerns.

The study's main limitation is that it did not include enough patients to detect a difference as small as 10 percent with statistical significance, Gibson said.

A separate study is currently underway to assess the potential benefits of ongoing Bendavia use in patients with heart failure.

INFORMATION:

The trial was funded by Bendavia's developer, Stealth BioTherapeutics.

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 #ACC15 for the latest news from the meeting.

The American College of Cardiology is a 49,000-member medical society that is the professional home for the entire cardiovascular care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit acc.org.



ELSE PRESS RELEASES FROM THIS DATE:

Novel anti-clotting therapy in halted trial no better than existing agents

2015-03-16
SAN DIEGO (March 15, 2015) -- A novel therapy that would allow doctors to turn the body's blood-clotting ability off and on in a more controlled way was about as effective as established anticoagulants in patients undergoing angioplasty but was associated with higher rates of moderate to severe bleeding, according to an analysis of data from a terminated Phase III trial presented at the American College of Cardiology's 64th Annual Scientific Session. The study was officially halted in August due to an excess of severe allergic reactions, so authors caution that the data ...

CT scans appear to dramatically improve diagnosis of heart disease

2015-03-16
SAN DIEGO (March 15, 2015) -- Use of computed tomography coronary angiography, which provides 3-D images of the heart, coupled with standard care allows doctors to more accurately diagnose coronary artery disease in patients presenting with chest pain, therefore, leading to more appropriate follow-up testing and treatments, according to research presented at the American College of Cardiology's 64th Annual Scientific Session. Data also showed a trend toward a lower incidence of heart attacks among the group receiving the tests, known as CT scans, compared to usual care. ...

After 1 year, patients on new drug fare better than standard therapy

2015-03-16
SAN DIEGO (March 15, 2015) -- Patients taking evolocumab--an investigational therapy previously shown to dramatically lower "bad" cholesterol--were half as likely to die, suffer a heart attack or stroke, be hospitalized or need a procedure to open blocked arteries compared with those who received standard care, according to research presented at the American College of Cardiology's 64th Annual Scientific Session in San Diego. In this open-label study, the rate of cardiovascular events was 2.18 percent after one year in the standard of care group, most of whom were on ...

SAPIEN 3 improves 30-day outcomes for major endpoints

2015-03-16
SAN DIEGO (March 15, 2015) -- The SAPIEN 3 heart valve demonstrated lower death, stroke and paravalvular leak rates than earlier generation devices in patients at high risk for surgery and showed encouraging results in intermediate-risk patients, according to research presented at the American College of Cardiology's 64th Annual Scientific Session. Transcatheter aortic valve replacement, known as TAVR, is approved for patients with severe aortic stenosis--narrowing of the valve in the heart's main artery--whose health profile makes them ineligible or high-risk candidates ...

Benefits seen for first-in-field brain shield used with TAVR

2015-03-16
SAN DIEGO (March 15, 2015) -- An investigational device that deflects debris away from the brain during transcatheter aortic valve replacement seems to improve in-hospital safety outcomes and cognitive scores at discharge, according to preliminary findings from a small randomized study presented at the American College of Cardiology's 64th Annual Scientific Session. The valve replacement procedure, known as TAVR, dislodges minute particles from the clogged valve, freeing them to float through the bloodstream. Much of this debris travels "downstream" from the heart, but ...

SAPIEN valve, surgery equivalent at 5-years

2015-03-16
SAN DIEGO (March 15, 2015) -- Five-year data suggest that the SAPIEN transcatheter heart valve is a feasible option for patients with severe aortic stenosis deemed to be at high risk for open-heart surgery, though valve leakage was more common with the first-generation valve evaluated in this study than with surgery, according to research from PARTNER I presented at the American College of Cardiology's 64th Annual Scientific Session. When the blockage of an aortic valve becomes severe, replacement is the only real treatment choice, but many elderly and frail people are ...

Self-expanding TAVR widens advantage over surgery at 2 years

2015-03-16
SAN DIEGO (March 15, 2015) -- Two-year data show a continued survival advantage for self-expanding transcatheter aortic valve replacement (TAVR) over standard surgery in high-risk patients with severe aortic stenosis, according to research presented at the American College of Cardiology's 64th Annual Scientific Session. Aortic stenosis--a problem that occurs when the valve in the heart's main artery doesn't open fully--forces the heart to work harder to pump blood and is life-threatening over time. Valve replacement is common when this condition becomes severe, but the ...

MitraClip valve repair continues to show benefit in commercial setting

2015-03-16
SAN DIEGO (March 15, 2015) --The commercial track record with transcatheter mitral valve repair, approved for patients at high risk for surgery, compares favorably with pre-approval reports, according to findings from a U.S. registry presented at the American College of Cardiology's 64th Annual Scientific Session. Healthy valves function as one-way gates that keep blood moving forward through the heart. Severely damaged mitral valves don't close properly, allowing blood to leak backward. If the valve isn't repaired or replaced, the condition can cause serious health ...

Police not prepared for death investigations

2015-03-16
Police are ill-equipped to investigate non-criminal deaths and face a challenge to avoid re-traumatising bereaved families as well as emotionally protecting themselves, according to QUT research. Investigating death: the emotional and cultural challenges for police found it was usually junior officers sent to sudden death investigations and tasked with not only gathering evidence, but also comforting family members and explaining the coronial process. The research has been published in the journal of Policing and Society. "The vast majority of deaths are neither ...

Risk patterns identified that make people more vulnerable to PTSD

2015-03-16
NEW YORK, NY - Researchers have built a new computational tool that identifies 800 different ways people are at increased risk for post-traumatic stress disorder (PTSD), permitting for the first time a personalized prediction guide. Results from the study out of NYU Langone Medical Center are published online (date) in the journal BMC Psychiatry. "Our study shows that high-risk individuals who have experienced a traumatic event can be identified less than two weeks after they are first seen in the emergency department," says Arieh Y. Shalev, MD, the Barbara Wilson ...

LAST 30 PRESS RELEASES:

Study tracks chromium chemistry in irradiated molten salts

Scientists: the beautiful game is a silver bullet for global health

Being physically active, even just a couple of days a week, may be key to better health

High-fat diet promote breast cancer metastasis in animal models

A router for photons

Nurses and AI collaborate to save lives, reduce hospital stays

Multi-resistance in bacteria predicted by AI model

Tinker Tots: A citizen science project to explore ethical dilemmas in embryo selection

Sensing sickness

Cost to build multifamily housing in California more than twice as high as in Texas

Program takes aim at drinking, unsafe sex, and sexual assault on college campuses

Inability to pay for healthcare reaches record high in U.S.

Science ‘storytelling’ urgently needed amid climate and biodiversity crisis

KAIST Develops Retinal Therapy to Restore Lost Vision​

Adipocyte-hepatocyte signaling mechanism uncovered in endoplasmic reticulum stress response

Mammals were adapting from life in the trees to living on the ground before dinosaur-killing asteroid

Low LDL cholesterol levels linked to reduced risk of dementia

Thickening of the eye’s retina associated with greater risk and severity of postoperative delirium in older patients

Almost one in ten people surveyed report having been harmed by the NHS in the last three years

Enhancing light control with complex frequency excitations

New research finds novel drug target for acute myeloid leukemia, bringing hope for cancer patients

New insight into factors associated with a common disease among dogs and humans

Illuminating single atoms for sustainable propylene production

New study finds Rocky Mountain snow contamination

Study examines lactation in critically ill patients

UVA Engineering Dean Jennifer West earns AIMBE’s 2025 Pierre Galletti Award

Doubling down on metasurfaces

New Cedars-Sinai study shows how specialized diet can improve gut disorders

Making moves and hitting the breaks: Owl journeys surprise researchers in western Montana

PKU Scientists simulate the origin and evolution of the North Atlantic Oscillation

[Press-News.org] Bendavia does not reduce scarring from angioplasty after heart attack
First clinical trial shows drug is well-tolerated but reveals no significant benefits