Navigation Links
Biodegradable stent proves non-inferior to drug-eluting stent
Date:5/21/2013

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."


'/>"/>

Contact: Isabelle Uzielli
iuzielli@europcr.com
33-612-233-492
European Society of Cardiology
Source:Eurekalert

Related medicine news :

1. Experiencing existential dread? Tylenol may do the trick
2. Scientists identify gene that is consistently altered in obese individuals
3. Metal stents are effective treatment for blocked bile ducts
4. Brain stent offers alternative to shunt for fixing potentially blinding vein narrowing
5. Scores that evaluate newborn intensive care units are inconsistent
6. Students in Educational First Steps Assisted Centers Show Persistent Benefits Far Beyond Early Childhood According to University of Texas at Dallas Study
7. Personal epigenetic signatures found consistent in prostate cancer patients metastases
8. Patient expectations of acute bronchitis not consistent with the best evidence
9. RSNA: New Study Finds Brain Angioplasty and Stents Safe and Effective for Stroke Patients
10. Study Supports Use of Brain Stents for Certain Stroke Patients
11. Brain angioplasty and stents found safe and effective for stroke patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... MN (PRWEB) , ... May 31, 2016 , ... DDL, ... the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ISO 594-2 ... common means of achieving a leak-free connection between two medical devices (e.g. a syringe ...
(Date:5/31/2016)... ... May 31, 2016 , ... Like jewels in a crown, the multiple awards ... is home to Ontario’s leading day spa and one of Canada’s few accredited 5 ... a unique concept to combine spa services with hair and beauty services ...
(Date:5/31/2016)... ... May 31, 2016 , ... The Orthopaedic Research and Education Foundation (OREF) ... David G. Lewallen, MD, began his term as president in March, succeeding John J. ... is OREF’s new president-elect. Richard F. Kyle, MD, will serve as chair, corporate development, ...
(Date:5/31/2016)... ... May 31, 2016 , ... ... 2016 Cool Vendors in Security Infrastructure Protection report by Gartner1 Inc. , Each ... series of research reports evaluating these innovative vendors and their products and services. ...
(Date:5/31/2016)... , ... May 31, 2016 , ... Super Powder, a ... to on the go individuals and dedicated athletes, continues to transform the nutritional supplement ... with whey, pea and milk protein, branched-chain amino acids (BCAA), alkaline minerals, wheat grass, ...
Breaking Medicine News(10 mins):
(Date:5/26/2016)... 26, 2016   Change Healthcare , ... network solutions and technology-enabled services designed to ... into a strategic channel partnership with SourceMed, ... solutions and revenue cycle management services that ... rehabilitation clinics to optimize revenue, operational efficiency ...
(Date:5/25/2016)... FDA 510(k) clearance covers Confocal Miniprobes ... and surgical applications Mauna Kea Technologies ... multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced ... the 12 th 510(k) clearance from United ... FDA clearance covers Confocal Miniprobes indicated for use ...
(Date:5/25/2016)... Deutschland und GERMANTOWN, Maryland , ... Zusammenarbeit mit Therawis bedient dringenden ...   QIAGEN N.V. (NASDAQ: ... bekannt, eine Lizenz- und Entwicklungsvereinbarung mit Therawis Diagnostics ... die Onkologie eingegangen zu sein. Ein erstes Projekt ...
Breaking Medicine Technology: