Nav: Home

Results from the BIO-RESORT trial presented at TCT 2016 and published in The Lancet

October 30, 2016

WASHINGTON - October 30, 2016 - Results of a large-scale, multicenter study found that treatment with two thin-strut drug-eluting stents were both non-inferior to a durable polymer drug-eluting stent and showed favorable clinical outcomes at one year in treating an all-comers population with a high proportion of patients with acute coronary syndromes.

Findings from the BIO-RESORT (TWENTE III) trial were reported today at the 28th 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. The study was also published simultaneously in The Lancet.

"In patients with coronary artery disease treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer may delay arterial healing and even cause adverse clinical events," said Clemens von Birgelen, MD, PhD, Professor of Medicine at Thoraxcentrum Twente in Enschede, Netherlands. "Biodegradable polymer stents might improve long-term outcomes, but studies with early biodegradable polymer stents that had thick stainless steel struts (120 μm) showed equivocal results. However, very thin-strut (60-81μm) biodegradable polymer stents that have flexible designs and thin, refined coatings are now available."

BIO-RESORT (TWENTE III) was a large-scale, investigator-initiated, assessor and patient-blinded, multicenter, three-arm trial that compared the safety and efficacy of two novel, very thin-strut biodegradable polymer stents to an established durable polymer stent (Resolute Integrity). Both biodegradable polymer stents have very thin struts but differ in the type, amount, distribution and degradation speed of their respective coating. The Synergy everolimus-eluting platinum chromium stent is the first and only biodegradable polymer drug-eluting stent approved by the FDA for clinical use in the United States and this was its first randomized assessment in an all-comers population. The Orsirio biodegradable polymer sirolimus-eluting cobalt chromium stent has been used clinically outside the United States.

Patients were randomly assigned (1:1:1) to treatment with the very thin-strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents or the durable polymer zotarolimus-eluting stent at four sites in the Netherlands. The primary endpoint was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularization) at 12 months, analyzed by intention-to-treat (non-inferiority margin: 3.5%).

Of the 3,514 patients enrolled and analyzed, 2,449 (69.7%) had acute coronary syndromes, which included 1,073 (30.5%) ST-elevation myocardial infarctions. Twelve-month follow-up was available in 3,490 (99.3%) patients. The primary endpoint was met by 4.7% (55/1,172) of patients assigned to everolimus-eluting stents, 4.7% (55/1,169) assigned to sirolimus-eluting stents and 5.4% (63/1,173) assigned to zotarolimus-eluting stents. The non-inferiority of the everolimus-eluting stent and the sirolimus-eluting stent was confirmed (both: -0.7% absolute risk difference, 95% CI:-2.4-1.1; upper limit of 1-sided 95% CI: 0.8%, Pnon-inferiority<0.0001). Definite stent thrombosis (ARC-defined) occurred in 0.3% (4/1,172), 0.3% (4/1,169) and 0.3% (3/1173) of patients, respectively (logrank-P=0.70 for both main comparisons).

"The one-year results of BIO-RESORT show that treatment with two very thin-strut biodegradable polymer stents and the thin strut durable polymer zotarolimus-eluting stent was similarly efficacious and safe with excellent one-year clinical outcomes in a complex population of all-comers," said Dr. von Birgelen. "The absence of a loss of one-year safety and efficacy with the use of these biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits."

The BIORESORT trial was funded by research grants from Biotronik, Boston Scientific, and Medtronic. Dr. von Birgelen disclosed institutional research grants from AstraZeneca, Biotronik, Boston Scientific, and Medtronic.

The results of the BIO-RESORT Trial will be presented on Sunday, October 30 at 9:20 AM ET in the Main Arena (Ballroom, Level 3) of the Walter E. Washington Convention Center.
-end-
About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit http://www.crf.org and http://www.tctconference.com.

Cardiovascular Research Foundation

Related Polymer Articles:

World first: New polymer goes for a walk when illuminated
Scientists have developed a new material that can undulate and therefore propel itself forward under the influence of light.
Polymer-coated silicon nanosheets -- an alternative to graphene
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene.
New polymer additive could revolutionize plastics recycling
Only 2 percent of the 78 million tons of manufactured plastics are currently recycled into similar products because polyethylene (PE) and polypropylene (PP), which account for two-thirds of the world's plastics, have different chemical structures and cannot be efficiently repurposed together.
Responsive filtration membranes by polymer self-assembly
Polymer self-assembly is a crucial tool for manufacturing membranes using scalable methods, enabling easier commercialization.
Biodegradable polymer coating for implants
Medical implants often carry surface substrates that release active substances or to which biomolecules or cells can adhere better.
Praise for polymer science
Engineer Glenn Fredrickson receives the William H. Walker Award for Excellence in Contributions to Chemical Engineering Literature.
When it comes to polymer fragility, size does matter
By combining a number of tools and techniques, a team of researchers from the US, Italy and China was able to find a more complete picture of the glass transition phenomenon in polymers and to point out where the polymers differ from small molecular liquids.
Better, stronger: Polymer breakthrough to improve things we use everyday
Medicine, mobile phones, computers and clothes could all be enhanced using the process for making paint, according to research by the University of Warwick.
CWRU researcher scaling up knotty polymer research
Researchers at Case Western Reserve University developed a technique that produces a long chain molecule in the shape of a trefoil knot.
New 3-D printed polymer can convert methane to methanol
Lawrence Livermore National Laboratory scientists have combined biology and 3-D printing to create the first reactor that can continuously produce methanol from methane at room temperature and pressure.

Related Polymer 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

Setbacks
Failure can feel lonely and final. But can we learn from failure, even reframe it, to feel more like a temporary setback? This hour, TED speakers on changing a crushing defeat into a stepping stone. Guests include entrepreneur Leticia Gasca, psychology professor Alison Ledgerwood, astronomer Phil Plait, former professional athlete Charly Haversat, and UPS training manager Jon Bowers.
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".