Nav: Home

New device reduces volume of radiographic dye in patients at risk of developing AKI

May 04, 2016

Orlando, Fla. - In the largest study of its kind, a new device has been found to significantly reduce the volume of radiographic dye without decreasing image quality in patients who are at risk of developing acute kidney injury (AKI) after undergoing a coronary angiography or percutaneous coronary intervention (PCI). The device -- known as AVERT™ -- did not, however, reduce contrast-induced AKI (CI-AKI). The AVERT results were presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions in Orlando, Fla.

CI-AKI is the sudden deterioration in renal function that can occur after the administration of radiographic dye -- or contrast media volume (CMV) -- during an interventional cardiac procedure. CI-AKI is associated with increased morbidity and mortality, and affects an estimated 20 to 30 percent of patients, particularly those with diabetes or previous renal impairment. Minimizing CMV in patients at risk of AKI is a critical preventative measure.

"Physicians are extremely careful about the volume of dye they administer to patients; the greater the volume, the more problems a physician can encounter," said Roxana Mehran, MD, FSCAI, director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and the study's lead author.

With the AVERT system, or device, the operator can control the volume of dye used during an interventional procedure. Once the appropriate amount of dye has been injected into the coronary, the remaining dye goes into a reservoir, rather than into the aorta.

The prospective, randomized multi-center study enrolled 578 patients, at 39 sites, who were considered to be at risk of CI-AKI while undergoing coronary angiography with or without PCI. The treatment group (n=292) included hydration and AVERT; the control group (n=286) received hydration only. The study's objectives were to assess total CMV used and determine the incidence of CI-AKI, which was defined as a 0.3 mg/dl increase in serum creatinine within 72 hours post-procedure.

Of the 568 patients with CI-AKI, PCI was performed on 239 (42.2 percent). The use of AVERT resulted in a 15.5 percent relative reduction in CMV in all patients (86 ± 51 ml vs. 101 ± 71 ml, p=0.002) and a 22.8 percent relative reduction in CMV for PCI patients (114 ml ± 55 vs. 147 ± 81 ml, p=0.001). There were no significant differences in CI-AKI (27.0 percent vs. 26.2 percent, p=0.72) or adverse event rates between the two groups.

"The bottom line is the AVERT system is safe, easy to use and reduces contrast media volume without sacrificing image quality," said Dr. Mehran. "While the use of this device did not result in a significant reduction of CI-AKI, there was one exception. A post-hoc analysis showed that in certain groups -- patients with a GFR between 40-60 -- CI-AKI was significantly reduced. The next step would be to study patients with moderate chronic kidney disease in a prospective randomized trial."
-end-
Dr. Mehran reported a research grant from Osprey Medical for this study.

Dr. Mehran presented "Effect of the AVERT™ Contrast Modulation System on Contrast Dose Reduction and Acute Kidney Injury After Coronary Angiography and PCI" on Wednesday, May 4, 2016 at 1:15 p.m. ET.

For more information about the SCAI 2016 Scientific Sessions, visit http://www. SCAI.org/SCAI2016.

About SCAI

The Society for Cardiovascular Angiography and Interventions is a 4,500-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive/interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's public education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit http://www.SCAI.org or http://www.SecondsCount.org. Follow @SCAI on Twitter for the latest heart health news.

Society for Cardiovascular Angiography and Interventions

Related Clinical Trials Articles:

Giving children a voice in clinical trials
Children as young as 8 years old with incurable cancer can reliably characterize the impact an experimental therapy has on their symptoms and quality of life -- even at the earliest stages of drug development -- making self-reported patient outcomes a potential new clinical trial endpoint.
Better health for women involved in clinical trials
Women who participate in obstetric and gynecology clinical trials experience improved health outcomes compared to those who are not involved in trials, according to research by Queen Mary University of London.
Final artificial pancreas clinical trials now open
Clinical trials are now enrolling to provide the final tests for a University of Virginia-developed artificial pancreas to automatically monitor and regulate blood-sugar levels in people with type 1 diabetes.
Why the bar needs to be raised for human clinical trials
Standards for authorizing first-time trials of drugs in humans are lax, and should be strengthened in several ways, McGill University researchers argue in a paper published today in Nature.
New drug formulary will help expedite use of agents in clinical trials
The National Cancer Institute (NCI) today launched a new drug formulary (the 'NCI Formulary') that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials.
Review examines diversity in dermatology clinical trials
Racial and ethnic groups can be underrepresented in medical research.
Reshaping the future of global clinical trials practice
Researchers at the University of Liverpool have developed a new international guideline to help standardize how results from clinical trial studies are reported.
Fewer cardiovascular drugs being studied in clinical trials
The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years even as cardiovascular disease has become the No.
Sex hormones skew outcomes in clinical trials -- here's how
Clinical research often excludes females from their trials under the assumption that 'one size fits all,' that a painkiller or antidepressant will be equally effective in subjects of either sex, but a growing number of scientists are criticizing this approach.
Nearly half of pediatric clinical trials go unfinished or unpublished
Clinical trials in children commonly go either uncompleted or unpublished, finds a comprehensive study conducted by researchers at Boston Children's Hospital.

Related Clinical Trials Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Jumpstarting Creativity
Our greatest breakthroughs and triumphs have one thing in common: creativity. But how do you ignite it? And how do you rekindle it? This hour, TED speakers explore ideas on jumpstarting creativity. Guests include economist Tim Harford, producer Helen Marriage, artificial intelligence researcher Steve Engels, and behavioral scientist Marily Oppezzo.
Now Playing: Science for the People

#524 The Human Network
What does a network of humans look like and how does it work? How does information spread? How do decisions and opinions spread? What gets distorted as it moves through the network and why? This week we dig into the ins and outs of human networks with Matthew Jackson, Professor of Economics at Stanford University and author of the book "The Human Network: How Your Social Position Determines Your Power, Beliefs, and Behaviours".