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 Tracking movement of immune cells identifies key first steps in inflammatory arthritis
23.01.2017 | Massachusetts General Hospital

nachricht Team discovers how bacteria exploit a chink in the body's armor
20.01.2017 | University of Illinois at Urbana-Champaign

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: Quantum optical sensor for the first time tested in space – with a laser system from Berlin

For the first time ever, a cloud of ultra-cold atoms has been successfully created in space on board of a sounding rocket. The MAIUS mission demonstrates that quantum optical sensors can be operated even in harsh environments like space – a prerequi-site for finding answers to the most challenging questions of fundamental physics and an important innovation driver for everyday applications.

According to Albert Einstein's Equivalence Principle, all bodies are accelerated at the same rate by the Earth's gravity, regardless of their properties. This...

Im Focus: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Tracking movement of immune cells identifies key first steps in inflammatory arthritis

23.01.2017 | Health and Medicine

Electrocatalysis can advance green transition

23.01.2017 | Physics and Astronomy

New technology for mass-production of complex molded composite components

23.01.2017 | Process Engineering

VideoLinks
B2B-VideoLinks
More VideoLinks >>>