Biodegradable stent proves non-inferior to drug-eluting stent

May 21, 2013

21 May 2013, Paris, France: The Orsiro stent, which is a novel stent platform eluting sirolimus from a biodegradable polymer, demonstrated non-inferiority to the Xience Prime everolimus-eluting stent for the primary angiographic endpoint of in-stent late lumen loss at nine months in the results of an imaging substudy reported at EuroPCR 2013 today.

The BIOFLOW-II substudy used intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to quantitatively assess neointimal hyperplasia and stent apposition at nine months after treating patients with symptomatic coronary artery disease due to de novo stenotic lesions. Patients were randomly assigned to receive either the Orsiro (Biotronik) or the Xience Prime stent (Abbott Vascular). Images from baseline and the nine-month follow-up were analysed by independent and blinded core laboratories.

Results showed no difference in the angiographic endpoint of in-stent late lumen loss between the two stents at nine months (0.10+0.32mm with the Orsiro stent vs. 0.11 + 0.29mm with the Xience Prime stent, p non-inferiority=<0.0001). Rates of target lesion failure were also similar at nine months (4.8% vs. 5.3%, p=0.47).

The IVUS substudy showed somewhat less neointimal hyperplasia over nine months with the Orsiro stent (0.16) than the Xience stent (0.43, p=0.043) with 100% stent apposition. 
Similarly, neointimal area as assessed by OCT at nine months was somewhat less with the Orsiro stent (0.74+0.38mm2 ) than with the Xience stent (1.00+0.44mm2, p=0.024). The proportion of well-apposed struts was similar with the two stents and the proportion of covered struts was slightly higher with the Orsiro stent (98.3% vs. 97.5%, p=0.042).

Reporting the results, Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, "The Orsiro sirolimus-eluting stent with a biodegradable polymer was non-inferior to the Xience Prime everolimus-eluting stent with a durable polymer for the primary angiographic endpoint of in-state late loss at nine months in this prospective, randomised trial."

He added, " We need to be careful in interpreting the results of a trial set up for an angiographic endpoint but we can speculate that neointimal hyperplasia may be somewhat less with the Orsiro stent platform. And an important additional finding is that this potentially improved efficacy is not compromised by a lower proportion of uncovered struts. In addition, clinical event rates were low and comparable with both stents." Looking to the future, he concluded, "These results will need to be extended to larger randomised trials including more complex patients and powered for clinical endpoints."
-end-


European Society of Cardiology

Related Biodegradable Polymer Articles from Brightsurf:

Flexible and biodegradable electronic blood vessels
Researchers in China and Switzerland have developed electronic blood vessels that can be actively tuned to address subtle changes in the body after implantation.

Chemists from RUDN University developed biodegradable antibacterial film for storing food
A team of chemists from RUDN University created an antibacterial coating for food products.

Safety of bioabsorbable polymer against durable polymer DES in high-risk PCI patients
A novel study sought to reveal whether drug-eluting stents (DES) coated with bioabsorbable polymer (BP) presented a safety advantage without compromising efficacy compared to durable polymer (DP) formulations.

Sulfonated chitosan studied as potential biodegradable corrosion inhibitor
Hydrate formation has long been a problem for hydrocarbon production in the Arctic.

BU chemists develop new biodegradable adhesive
Boston University professor Mark Grinstaff unveiled biodegradable adhesive that is made of entirely naturally derived chemical components.

Ecofriendly nano-fabrication achieved with biodegradable chitosan nanoparticles
The Korea Institute of Machinery and Materials (KIMM) succeeded in creating glass with self-cleaning and antireflective functions through the biodegradable chitosan nanoparticle coating.

Developed biodegradable anti-cancer treatment micro-robot
DGIST Professor Hongsoo Choi's team developed a biodegradable micro-robot that performs both drug release and hyperthermia treatment into a desired area.

Tiny biodegradable circuits for releasing painkillers inside the body
EPFL researchers have developed biodegradable microresonators that can be heated locally with a wireless system.

BioSA -- Bridging the gap with biodegradable metals
The University of Malta has teamed up with Mater Dei Hospital to address the shortcomings of current bone scaffolds on the market in a project entitled Biodegradable Iron for Orthopaedic Scaffold Applications -- BioSA.

Kazan University Clinic testing biodegradable plant-based implants
The prosthetics technology is based on potato and corn materials which serve as 'food' for the replaced tissues and can be slowly absorbed by the patient's own tissue.

Read More: Biodegradable Polymer News and Biodegradable Polymer Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.