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

Leaders trial: 3-year data on stent with biodegradable polymer to be presented at TCT 2010

2010-09-21
(Press-News.org) WASHINGTON, DC – SEPTEMBER 21, 2010 – Three-year data from the prospective, randomized LEADERS trial demonstrate the equivalence of a biolimus A9-eluting stent with a biodegradable polymer vs. a sirolimus-eluting stent with a durable polymer. The results will be presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The study is to be presented by Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center (Rotterdam, Netherlands.)

"We believe that the development of drug-eluting stents with biodegradable polymers is very promising for patients," Dr. Serruys said. "We are confident that the three-year data on LEADERS will continue to show the equivalent safety and efficacy to a stent with a durable polymer observed in the two-year data presented at TCT 2009."

Drug-eluting stents (DES) effectively reduce the rate of target lesion revascularization (TLR) – the rate at which vessels need to be treated again following angioplasty -- compared with bare-metal stents (BMS). Although rates of death or heart attack are similar, there is concern of an increased incidence of very late stent thrombosis (ST), the occurrence of a blood clot associated with drug-eluting stents potentially related to the durable polymer. In the trial, researchers compared a stent that releases biolimus from a biodegradable polymer (BES) which breaks down inside the body into carbon dioxide and water after 6-9 months.

The overall cumulative percentages of MACE up to 24 months were equivalent: 13.0% for BES and 15.4% for SES, including cardiac death (3.2% versus 4.0%), MI (6.4% versus 5.8%), clinically indicated TVR (7.7% versus 8.8%) and definite stent thrombosis (2.2% versus 2.5%). BES was non-inferior to SES up to 24 months of follow-up.

LEADERS follow-up data at 24 months has confirmed that the 9 and 12 months results are robust, with continuing safety and efficacy. A detailed analysis of the 36 month follow-up data will be presented as during the Featured Clinical Research II session at 6:00 PM on Wednesday September 22 in Room 140A at the Washington Convention Center.

The purpose of the LEADERS trial is to compare the safety and efficacy of BES with an established stent platform releasing sirolimus from a durable polymer (SES) in a large scale, all-comers, non-inferiority trial. Earlier reported results from the LEADERS trial have confirmed that the safety and efficacy of the BES as first observed at the trials' primary and secondary endpoints is robust throughout 2 years of follow up.

Once the BES has released its drug and polymer after 6-9 months, the study suggests that it essentially becomes a bare metal stent (BMS) and thus should have a similar long-term safety profile. The purpose of this presentation is to share new data to determine whether a biodegradable polymer coated DES has an improved safety profile over a 1st generation DES with a durable polymer over a 36 month follow up interval in a real world patient population.

LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) is a multi-center, randomized, assessor-blind, non-inferiority trial performed at 10 European interventional cardiology sites in an all comer, "real world" patient population trial without limitation with respect to lesion length, number of treated lesions or vessels as well as clinical indication (chronic stable angina vs. acute coronary syndromes.) 1,707 patients were enrolled and randomly allocated 1:1 to BES or SES. The primary endpoint of the trial was major adverse cardiac events (MACE) as a composite of cardiac death, myocardial infarction (MI), or justified target vessel revascularization (TVR) within 9 months. All patients are to be followed up to 5 years.

INFORMATION: About CRF and TCT

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from over 90 countries around the world to present and discuss the latest developments in the field.

For more information, visit www.crf.org.


ELSE PRESS RELEASES FROM THIS DATE:

New stent design demonstrates superiority at 6 months; 1 year data to be presented at TCT 2010

2010-09-21
WASHINGTON, DC – SEPTEMBER 21, 2010 – A new drug-eluting stent design demonstrated superiority over a traditional drug-eluting stent at 6 months, according to a study led by Laura Mauri, MD, Associate Professor of Medicine, Brigham and Women's Hospital, Harvard Medical School (Boston, MA.) The study is being presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. "This new stent proved superior to a traditional drug-eluting stent for the primary endpoint of in-stent late loss ...

Data show clinical benefit from mitral valve clip device

2010-09-21
WASHINGTON, DC – SEPTEMBER 21, 2010 – A percutaneous mitral valve clip designed to stop mitral valve regurgitation demonstrated clinical benefit as measured by the degree of mitral regurgitation, according to a study presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Mitral valve regurgitation is one of the most common forms of heart disease. The study was led by James Hermiller, MD, Director of Cardiovascular Intervention at the St. Vincent Heart Center of Indiana (Indianapolis, ...

Study examines use of stent with bioabsorbable polymer

2010-09-21
WASHINGTON, DC – SEPTEMBER 21, 2010 – Three-year data demonstrated that satisfactory clinical and safety outcomes of sirolimus eluting stents with a biodegradable polymer were sustained in a real world setting. The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. "The three-year data from the CREATE study is further evidence that biodegradable polymers represent the future of stent design," said Yaling Han, MD, the lead investigator and Director in the ...

First in-human study of robotically assisted PCI system demonstrates safety, feasibility

2010-09-21
WASHINGTON, DC – SEPTEMBER 21, 2010 – The first in-human study of a robotically assisted percutaneous coronary intervention system demonstrated that the technique was safe and feasible. The results of the study were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. The current practice of percutaneous coronary intervention (PCI) still presents multiple limitations and potential hazards for both the patient (radiation exposure, contrast media use) and the operator (spine ...

Hula Girl Beverages Ride the Wave into Southern California Bringing Its Liquid Paradise to a New Market

2010-09-21
After taking Northern California by tropical storm, Hula Girl Beverages brings the taste of the islands to your local Southern California stores and restaurants with its visually capturing and smooth-drinking Hula Girl pre-mixed, premium tropical rum-based cocktail blends. Originally conceived when the owners were traveling in Hawaii, Hula Girl Beverages are quickly becoming the "it" drink of LA and San Diego insiders with a taste for the island lifestyle. This hot, hip and, dare we say, sexy drink has been featured in such high end restaurant and beverage events as The ...

Advantages of Building a Home Builders House with Displayhouses.com.au

2010-09-21
Display Houses, one of the leading home builders' industry and when it comes to giving assistance to people who want to build their dream homes. Helping them decide which applies best for them and the things that they can get from building their home appropriately with details that will help them in keeping up with their budget and savings. DisplayHouses.com.au is a website that would enable people in helping people achieve their goals in building their houses and make a major improvement for houses that needs maintenance and renovations. What's good with displayhouses.com.au ...

University Researched Mind-Body Sleep Aid Unveiled

2010-09-21
It's the first all natural, supplement-free, mind-body insomnia solution of it's kind. Those desperately seeking sleep are turning to a new development in mind-body medicine that has impressive validation through extensive university research (http://www.sleephelpforinsomnia.com/insomnia_clinical_research-mind-body-bridging.htm) among the toughest insomnia patients. Pioneered by Stanley H. Block, MD, Mind-Body bridging has been clinically proven to relax a part of the brain called the Default Mode Network, which has been recently validated in MRI studies. Dr. Block ...

Economically Priced Wedding Photography Rates in Scotland

2010-09-21
A wedding, needless to say, is the single most important event in the lives of many. However, due to the unstable economic and weak market conditions people are skeptical of lavishly spending on weddings and strive to curb down costs. This is where wedding photography ( http://www.sstudio.co.uk ) services like Sstudio come into existence where they ensure the prices they quote for excellently captured and wonderfully preserved photographic memories of your wedding are substantially below the market price. This season Sstudio is proud to present a variety of lucrative ...

San Diego Self Storage Expands Into Temecula

2010-09-21
San Diego's largest private self storage operator has selected a premier site launching its expansion into Temecula with the acquisition of Butterfield Ranch Self Storage, a 635-unit storage facility located on 4.89 acres at the corner of Hwy 79 and Butterfield Stage Road in Temecula. Distinctive features of the Butterfield Ranch facility include 35 RV/boat storage spaces, security cameras and individually alarmed units and a two-story climate-controlled building with 154 climate-controlled units, 93 of which are currently available for rent. The project totals 106,000 ...

North Wind Publishing to release new book "What Faith and Love Can Do"

2010-09-21
New book to be released: "What Faith and Love Can Do" (ISBN 978-0-9720620-9-1, paperback ($13.95, e-book $9.95, North Wind Publishing, November 2010, 122 pages, 5 x 8 trim). What Faith and Love Can Do combines the author's previous book Take My Hand with new material about picking up the pieces of his life, facing being alone, new health problems, finding new love and getting married again. This book invites the reader to journey with Dan Cole as he confronts his life's greatest challenges—the death of his wife, Sandy, from cancer and his simultaneous cancer diagnosis and ...

LAST 30 PRESS RELEASES:

Community partners key to success of vaccine clinic focused on neurodevelopmental conditions

Low-carbon collaborative dual-layer optimization for energy station considering joint electricity and heat demand response

McMaster University researchers uncover potential treatment for rare genetic disorders

The return of protectionism: The impact of the Sino-US trade war

UTokyo and NARO develop new vertical seed distribution trait for soybean breeding

Research into UK’s use of plastic packaging finds households ‘wishcycle’ rather than recycle – risking vast contamination

Vaccine shows promise against aggressive breast cancer

Adverse events affect over 1 in 3 surgery patients, US study finds

Outsourcing adult social care has contributed to England’s care crisis, argue experts

The Lancet: Over 800 million adults living with diabetes, more than half not receiving treatment, global study suggests

New therapeutic approach for severe COVID-19: faster recovery and reduction in mortality

Plugged wells and reduced injection lower induced earthquake rates in Oklahoma

Yin selected as a 2024 American Society of Agronomy Fellow

Long Covid could cost the economy billions every year

Bluetooth technology unlocks urban animal secrets

This nifty AI tool helps neurosurgeons find sneaky cancer cells

Treatment advances, predictive biomarkers stand to improve bladder cancer care

NYC's ride-hailing fee failed to ease Manhattan traffic, new NYU Tandon study reveals

Meteorite contains evidence of liquid water on Mars 742 million years ago

Self-reported screening helped reduce distressing symptoms for pediatric patients with cancer

Which risk factors are linked to having a severe stroke?

Opening borders for workers: Abe’s profound influence on Japan’s immigration regime

How skills from hospitality and tourism can propel careers beyond the industry

Research shows managers of firms handling recalls should review media scrutiny before deciding whether to lobby

New model system for the development of potential active substances used in condensate modifying drugs

How to reduce social media stress by leaning in instead of logging off

Pioneering research shows sea life will struggle to survive future global warming

In 10 seconds, an AI model detects cancerous brain tumor often missed during surgery 

Burden of RSV–associated hospitalizations in US adults, October 2016 to September 2023

Repurposing semaglutide and liraglutide for alcohol use disorder

[Press-News.org] Leaders trial: 3-year data on stent with biodegradable polymer to be presented at TCT 2010