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.