Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New type of sirolimus-eluting stent demonstrates superior results

23.09.2009
A new type of sirolimus-eluting stent (SES) successfully showed significantly greater neointimal suppression than the paclitaxel-eluting stent (PES) with greater vessel wall integrity surrounding the stent, confirming the finding of superiority of the SES over the PES stent for the trial's primary endpoint of in-stent late loss.

Results from the RES-ELUTION I Trial on the safety and effectiveness of a new sirolimus-eluting stent in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

RES-ELUTION I, which began in March 2008, is a multi-center, randomized, single-blind controlled trial comparing the sirolimus-eluting reservoir-based stent (SES) with a paclitaxel–eluting stent (PES) system in de novo native coronary artery lesions. A total of 394 subjects were randomized to treatment with either the sirolimus-eluting or paclitaxel-eluting stents. Principal investigators of the trial included Alexandre Abizaid, MD, John Ormiston, MD and Christian Spaulding, MD.

Clinical results will be presented by John A. Spertus, MD on Thursday, September 24 at 2:45 p.m. during the Featured Clinical Trials: First Report Investigations session in Room 131. In addition to the oral presentation, a detailed intravascular ultrasound (IVUS) analysis will be on display as a poster abstract (TCT-360) on Tuesday, September 22 between 8:00 a.m. and 10:00 a.m. in Hall D of The Moscone Center. The poster will be presented by Hiromasa Otake, MD of Stanford University (Stanford, Calif.) on behalf of the RES-ELUTION I investigators.

This new sirolimus-eluting stent (SES) utilizes a reservoir technology that incorporates a number of small wells, each acting as a depot into which drug-polymer compositions are loaded. The stent's design achieves both a significant reduction in total polymer load as well as a reduction in tissue-polymer contact by more than 75% compared to conventional DES in which the entire stent surface is coated with polymer. Its use of a bioresorbable polymer is another theoretical advantage from the safety perspective, allowing the drug-eluting stent to become simple bare metal within the vessel wall approximately 3 months after deployment.

In this clinical trial, detailed arterial responses to the new DES technology were also investigated in vivo using intravascular ultrasound (IVUS). With IVUS, a tiny catheter is inserted into a coronary vessel where high-frequency sound waves reflect off tissue or vessel walls. The reflected waves create a cross-sectional image from within the vessel to aid in visualizing its structure, thereby providing both quantitative and qualitative information on vessel reaction after stenting.

Serial IVUS (immediately post-stenting and 6-month follow-up) was performed in a pre-defined IVUS subset of 100 patients (52 SES in 50 patients; 52 PES in 50 patients). Volumetric IVUS analysis demonstrated significantly less neointimal proliferation in the sirolimus-eluting stent (% neointimal volume: 5.5±11.0 vs. 11.5±9.7, p=0.016), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing (neointimal area/stent area) than PES. In addition, serial IVUS analysis revealed significantly less outward vessel remodeling in the SES than in PES. The incidence of late-acquired incomplete stent apposition (ISA) was similar between the SES and PES. However, SES was associated with less outward vessel remodeling at the ISA segment, possibly suggesting different underlying mechanisms of this phenomenon.

"Our study is the first report investigating the detailed arterial responses to this new DES technology, with a randomized, blinded comparison of sirolimus-eluting stents with paclitaxel-eluting stents in human de novo native coronary lesions," said Dr. Otake.

"The combination of a different formulation strategy with different types of drug appeared to impact arterial response after DES therapy," Dr. Otake added. "Our study confirmed that the advanced formulation strategy of this new DES can perform with efficacy exceeding a first-generation DES with the potential for improved long-term safety because it turns into a bare metal stent within 3 months. This stent may be a promising DES option to treat the patients with coronary artery disease while embracing the long-term safety of bare metal stents."

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field of interventional cardiology and vascular medicine.

Judy Romero | EurekAlert!
Further information:
http://www.crf.org

More articles from Health and Medicine:

nachricht New vaccine production could improve flu shot accuracy
25.07.2017 | Duke University

nachricht Chances to treat childhood dementia
24.07.2017 | Julius-Maximilians-Universität Würzburg

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Carbon Nanotubes Turn Electrical Current into Light-emitting Quasi-particles

Strong light-matter coupling in these semiconducting tubes may hold the key to electrically pumped lasers

Light-matter quasi-particles can be generated electrically in semiconducting carbon nanotubes. Material scientists and physicists from Heidelberg University...

Im Focus: Flexible proximity sensor creates smart surfaces

Fraunhofer IPA has developed a proximity sensor made from silicone and carbon nanotubes (CNT) which detects objects and determines their position. The materials and printing process used mean that the sensor is extremely flexible, economical and can be used for large surfaces. Industry and research partners can use and further develop this innovation straight away.

At first glance, the proximity sensor appears to be nothing special: a thin, elastic layer of silicone onto which black square surfaces are printed, but these...

Im Focus: 3-D scanning with water

3-D shape acquisition using water displacement as the shape sensor for the reconstruction of complex objects

A global team of computer scientists and engineers have developed an innovative technique that more completely reconstructs challenging 3D objects. An ancient...

Im Focus: Manipulating Electron Spins Without Loss of Information

Physicists have developed a new technique that uses electrical voltages to control the electron spin on a chip. The newly-developed method provides protection from spin decay, meaning that the contained information can be maintained and transmitted over comparatively large distances, as has been demonstrated by a team from the University of Basel’s Department of Physics and the Swiss Nanoscience Institute. The results have been published in Physical Review X.

For several years, researchers have been trying to use the spin of an electron to store and transmit information. The spin of each electron is always coupled...

Im Focus: The proton precisely weighted

What is the mass of a proton? Scientists from Germany and Japan successfully did an important step towards the most exact knowledge of this fundamental constant. By means of precision measurements on a single proton, they could improve the precision by a factor of three and also correct the existing value.

To determine the mass of a single proton still more accurate – a group of physicists led by Klaus Blaum and Sven Sturm of the Max Planck Institute for Nuclear...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Closing the Sustainability Circle: Protection of Food with Biobased Materials

21.07.2017 | Event News

»We are bringing Additive Manufacturing to SMEs«

19.07.2017 | Event News

The technology with a feel for feelings

12.07.2017 | Event News

 
Latest News

NASA mission surfs through waves in space to understand space weather

25.07.2017 | Physics and Astronomy

Strength of tectonic plates may explain shape of the Tibetan Plateau, study finds

25.07.2017 | Earth Sciences

The dense vessel network regulates formation of thrombocytes in the bone marrow

25.07.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>