Feature | October 08, 2014

Abbott Initiates ABSORB IV Trial to Evaluate Quality of Life and Cost Savings of Dissolving Heart Device

October 8, 2014 — Abbott announced the start of the ABSORB IV clinical trial, which will test whether the Absorb bioresorbable vascular scaffold (BVS) is more cost effective and offers a higher quality of life than a best-in-class, permanent, metallic drug-eluting stent. Absorb is the world's first drug-eluting BVS and functions like a metallic stent by opening up blocked blood vessels in the heart and restoring blood flow. However, unlike a metallic stent Absorb dissolves over time. ABSORB IV is designed to enroll approximately 3,000 people with coronary artery disease, mostly in the United States.

ABSORB IV is the first randomized heart stent trial to prospectively measure angina as a primary endpoint at one year. Measuring angina is significant because of its impact on quality of life and healthcare costs. Overall, people who have angina following a percutaneous coronary intervention (PCI) use more healthcare resources than those without angina. Studies have shown that while PCI with metallic stents is highly effective by reducing angina for 75 percent of treated patients, about 25 percent of people treated still experience angina over the course of the year following PCI. In addition, people with frequent angina typically have a lower quality of life because they are less likely to lead active lifestyles than those without angina.

Randomized data recently presented from the ABSORB II clinical trial, conducted primarily in Europe, showed that people treated with Absorb experienced significantly less angina compared to those who received a permanent metallic stent. The ABSORB IV trial is designed to confirm with these novel findings that treatment with the Absorb device can help provide people with heart disease a higher quality of life after a heart stent procedure.  

The other primary endpoint of ABSORB IV assesses long-term clinical safety and performance based on the change in target lesion failure (TLF) from one to five years. TLF is a traditional endpoint in heart stent trials used to measure the safety and effectiveness of a device. Data from the ABSORB II clinical trial showed a similar rate of TLF between Absorb and Xience at one year. ABSORB IV is designed to demonstrate that this performance is consistent out to five years in people treated in the United States.

"The ABSORB IV trial will rigorously and prospectively examine whether there are differences in angina rates between a permanent stent and a dissolvable device after a percutaneous coronary intervention," said Gregg Stone, M.D., FACC, FSCAI, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital, and principal investigator of the ABSORB IV trial. "People care about their quality of life following a procedure, and this trial will allow us to measure that important outcome, in addition to traditional clinical endpoints."

Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants, such as dissolving sutures. Absorb is called a scaffold to indicate its temporary structure, and the scaffold provides support to the vessel until the artery can stay open on its own.  Absorb slowly dissolves into the blood vessel, leaving behind a vessel that has the potential to resume more natural function and movement because it is not restricted by a permanent metallic stent.

In ABSORB IV, people will be randomly assigned to receive either Absorb or a best-in-class, drug-eluting permanent metallic stent, representing today's standard of care. The trial will implement rigorous measures to minimize patient bias and a patient perception effect. The first hospital to enroll people into the trial is the Christ Hospital Heart and Vascular Center and the Lindner Research Center in Cincinnati.

"The ABSORB IV trial is an important step forward in determining the relative clinical benefits associated with the dissolvable device compared with the permanent metal stent," said Dean Kereiakes, M.D., FACC, FSCAI, medical director, the Christ Hospital Heart and Vascular Center and the Lindner Research Center, and national co-principal investigator of the ABSORB IV trial. "Metal stents have been an important therapy for coronary artery disease for almost 25 years, but may have limitations. ABSORB IV is designed to demonstrate differences in clinical outcomes, angina symptoms and quality of life between stent types."

The data from the ABSORB IV trial will be combined with the data from the ABSORB III trial to create a population of more than 5,000 people studied in the U.S. This data set, which is the largest of its kind for bioresorbable heart devices, provides an opportunity to rigorously evaluate the performance of Absorb compared to the current standard of a metallic drug-eluting stent across a number of measures, including the broader health economic impact of this innovative therapy.

"ABSORB IV is a new approach to heart stent trials and the first time angina as a quality of life measure has been included as a co-primary endpoint," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The current standard of care for narrowed coronary vessels offers strong clinical outcomes for most people. However, people continue to suffer from debilitating chest pain after their procedures, which lowers their quality of life and increases associated healthcare costs. By focusing on the patients and how they feel after a procedure, this trial sets a new bar for how we measure health outcomes and how we treat people with coronary artery disease."

For more information: www.abbott.com

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp