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Results of the HYBRID trial presented at TCT 2013

PUBLIC RELEASE DATE:

31-Oct-2013

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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation

'Hybrid procedure' combining minimally invasive corornary artery bypass surgery (CABG) with percutaneous coronary intervention is feasible and safe compared with traditional CABG

SAN FRANCISCO, CA October 31, 2013 A hybrid approach to treating coronary artery disease that involves a "hybrid procedure" combining a minimally invasive bypass surgery with percutaneous coronary intervention (PCI) was found to be feasible and safe in a clinical trial. This is the first randomized study of the technique. These findings were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Hybrid coronary artery revascularization (HCR) as studied within this trial combined a minimally invasive left internal mammary artery bypass grafting to the left anterior descending artery (LAD) with percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to other coronary arteries. Due to the lack of data from large, prospective randomized trials comparing HCR with standard surgical revascularization, HYBRID was designed as a feasibility study to assess the safety and efficacy of HCR in patients with multi-vessel coronary artery disease referred for standard coronary artery bypass grafting (CABG).

Two hundred consecutive patients, with angiographically confirmed multi-vessel coronary artery disease (CAD) involving the LAD and a critical (>70%) lesion in at least one major epicardial vessel (except LAD) amenable to both PCI and CABG, were randomized in a 1:1 fashion to HCR or standard surgical revascularization.

The primary objectives of this trial were to investigate the feasibility and safety of HCR. The feasibility assessment was defined both as the percentage of patients in the hybrid group that had a complete HCR procedure according to the study protocol and a percentage that had to be converted to standard CABG. The safety endpoint was the occurrence of MACE (major adverse cardiac events) such as death, myocardial infarction, stroke, repeat revascularization, major bleeding within the 12 month period after randomization.
In the trial, 93.9 percent of the patients in the hybrid group had the completed HCR procedure and 6.1 percent were converted to CABG.

At one year, 92.2 percent of the CABG group and 89.8 percent of the hybrid group were free from MACE. No strokes were reported in either group. The rate of death was 2.9 percent in the CABG group and 2.0 percent in the HCR group.

"This first randomized pilot study on hybrid coronary revascularization shows promising feasibility and safety results supporting the idea of hybrid coronary revascularization in patients with multi-vessel disease," said Michal Hawranek, MD, PhD, on behalf of the investigation team at the Silesian Center for Heart Disease in Zabrze, Poland.

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The HYBRID trial was funded by the Ministry of Science and Higher Education of Poland. Dr. Hawranek reported no disclosures.

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. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.

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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Results of the HYBRID trial presented at TCT 2013

PUBLIC RELEASE DATE:

31-Oct-2013

[

| E-mail

]

Share
Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation

'Hybrid procedure' combining minimally invasive corornary artery bypass surgery (CABG) with percutaneous coronary intervention is feasible and safe compared with traditional CABG

SAN FRANCISCO, CA October 31, 2013 A hybrid approach to treating coronary artery disease that involves a "hybrid procedure" combining a minimally invasive bypass surgery with percutaneous coronary intervention (PCI) was found to be feasible and safe in a clinical trial. This is the first randomized study of the technique. These findings were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Hybrid coronary artery revascularization (HCR) as studied within this trial combined a minimally invasive left internal mammary artery bypass grafting to the left anterior descending artery (LAD) with percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to other coronary arteries. Due to the lack of data from large, prospective randomized trials comparing HCR with standard surgical revascularization, HYBRID was designed as a feasibility study to assess the safety and efficacy of HCR in patients with multi-vessel coronary artery disease referred for standard coronary artery bypass grafting (CABG).

Two hundred consecutive patients, with angiographically confirmed multi-vessel coronary artery disease (CAD) involving the LAD and a critical (>70%) lesion in at least one major epicardial vessel (except LAD) amenable to both PCI and CABG, were randomized in a 1:1 fashion to HCR or standard surgical revascularization.

The primary objectives of this trial were to investigate the feasibility and safety of HCR. The feasibility assessment was defined both as the percentage of patients in the hybrid group that had a complete HCR procedure according to the study protocol and a percentage that had to be converted to standard CABG. The safety endpoint was the occurrence of MACE (major adverse cardiac events) such as death, myocardial infarction, stroke, repeat revascularization, major bleeding within the 12 month period after randomization.
In the trial, 93.9 percent of the patients in the hybrid group had the completed HCR procedure and 6.1 percent were converted to CABG.

At one year, 92.2 percent of the CABG group and 89.8 percent of the hybrid group were free from MACE. No strokes were reported in either group. The rate of death was 2.9 percent in the CABG group and 2.0 percent in the HCR group.

"This first randomized pilot study on hybrid coronary revascularization shows promising feasibility and safety results supporting the idea of hybrid coronary revascularization in patients with multi-vessel disease," said Michal Hawranek, MD, PhD, on behalf of the investigation team at the Silesian Center for Heart Disease in Zabrze, Poland.
###

The HYBRID trial was funded by the Ministry of Science and Higher Education of Poland. Dr. Hawranek reported no disclosures.

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. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.

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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Source: http://www.eurekalert.org/pub_releases/2013-10/crf-rot_3103113.php
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NIH scientists develop candidate vaccine against respiratory syncytial virus

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31-Oct-2013

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Contact: Anne A. Oplinger
aoplinger@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases

Structure-based design may be key to successful vaccine for common childhood illness

An experimental vaccine to protect against respiratory syncytial virus (RSV), a leading cause of illness and hospitalization among very young children, elicited high levels of RSV-specific antibodies when tested in animals, according to a report in the journal Science.

Early-stage human clinical trials of the candidate vaccine are planned. Scientists from the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, built on their previous findings about the structure of a critical viral protein to design the vaccine. The team was led by Peter D. Kwong, Ph.D., and Barney S. Graham, M.D., Ph.D.

In the United States, RSV infection is the most common cause of bronchiolitis (inflammation of small airways in the lungs) and pneumonia in children less than one year old and the most common cause for hospitalization in children under five. Worldwide, it is estimated that RSV is responsible for nearly 7 percent of deaths in babies aged 1 month to 1 year; only malaria kills more children in this age group. Others at risk for severe disease following RSV infection include adults over age 65 and those with compromised immune systems.

Many common diseases of childhood are now vaccine-preventable, but a vaccine against RSV infection has eluded us for decades, said NIAID Director Anthony S. Fauci, M.D. This work marks a major step forward. Not only does the experimental vaccine developed by our scientists elicit strong RSV-neutralizing activity in animals, but, more broadly, this technique of using structural information to inform vaccine design is being applied to other viral diseases, including HIV/AIDS.

Earlier this year, the VRC team obtained atomic-level details of an RSV proteincalled the fusion (F) glycoproteinbound to a broadly neutralizing human RSV antibody. The protein-antibody complex gave scientists their first look at the F glycoprotein as it appears before it fuses with a human cell. In this pre-fusion shape, F glycoprotein contains a region vulnerable to attack by broadly neutralizing antibodies (antibodies able to block infection from the common strains of RSV).

Once RSV fuses with a cell, this vulnerable area, named antigenic site zero by the researchers, is no longer present on the rearranged F protein. In natural RSV infection, the immune system produces antibodies against both the pre-fusion and post-fusion forms of F glycoprotein, but the antibodies to antigenic site zero, which is only present on the pre-fusion form, have much stronger neutralizing activity. Therefore, a vaccine against RSV would have greater chance of success by eliciting antibodies directed at F glycoprotein in its pre-fusion configuration.

In their current publication, Drs. Kwong and Graham describe how they used this structural information to design and engineer F glycoprotein variants that retained antigenic site zero even when no antibody was bound to it. The goal was to create stable variants that could serve as the foundation for a vaccine capable of eliciting a potent antibody response. The researchers designed more than 100 variants; of these, 3 were shown by X-ray crystallography to retain the desired structure. The engineered variants were then used as vaccines in a series of experiments in mice and rhesus macaques.

In both mice and macaques, the researchers found that the more stable the protein, the higher the levels of neutralizing antibodies elicited by vaccination. The levels of antibody made in response to one of the engineered F glycoproteins were more than 10 times higher than those produced following vaccination with post-fusion F glycoprotein and well above levels needed to protect against RSV infection.

Here is a case in which information gained from structural biology has provided the insight needed to solve an immunological puzzle and apply the findings to address a real-world public health problem, said Dr. Graham. He and the VRC scientists are continuing to refine the engineered F glycoproteins and hope to launch early-stage human clinical trials of a candidate RSV vaccine as soon as clinical grade material can be manufactured, a process that takes about 18 to 24 months to complete.

Previously, structure-based vaccine design held promise at a conceptual level, said Dr. Kwong. This advance delivers on that promise and sets the stage for similar applications of structure-guided design to effective vaccines against other pathogens.

Dr. Fauci added, This latest advance underscores the advantages of the VRCs organizational design, where experts in RSV virology, vaccinology and clinical studies, such as Dr. Graham, are in daily contact with Dr. Kwong and others who are experts in structural biology. Such close collaboration across disciplines allows for rapid testing of new approaches to a given problem.

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NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIH...Turning Discovery Into Health

References:
JS McLellan et al. Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus. Science DOI: 10.1126/science.1243283 (2013).

JS McLellan et al. Structure of RSV fusion glycoprotein trimer bound to a prefusion-specific neutralizing antibody. Science DOI: 10.1126/science.1234914 (2013).