New Type Of Sirolimus-Eluting Stent Demonstrates Superior Results
Martes, Septiembre 22nd, 2009A new type of sirolimuseluting stent (SES) successfully showed significantly greater neointimal suppression than the paclitaxeleluting stent (PES) with greater vessel wall integrity surrounding the stent, confirming the finding of superiority of the SES over the PES stent for the trials primary endpoint of instent late loss.
Results from the RESELUTION I Trial on the safety and effectiveness of a new sirolimuseluting 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).
RESELUTION I, which began in March 2008, is a multicenter, randomized, singleblind controlled trial comparing the sirolimuseluting reservoirbased stent (SES) with a paclitaxeleluting stent (PES) system in de novo native coronary artery lesions. A total of 394 subjects were randomized to treatment with either the sirolimuseluting or paclitaxeleluting 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 245 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 is being displayed as a poster abstract (TCT360) on Tuesday, September 22 between 800 a.m. and 1000 a.m. in Hall D of The Moscone Center. The poster is being presented by Hiromasa Otake, MD of Stanford University (Stanford, Calif.) on behalf of the RESELUTION I investigators.
This new sirolimuseluting stent (SES) utilizes a reservoir technology that incorporates a number of small wells, each acting as a depot into which drugpolymer compositions are loaded. The stents design achieves both a significant reduction in total polymer load as well as a reduction in tissuepolymer 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 drugeluting 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 highfrequency sound waves reflect off tissue or vessel walls. The reflected waves create a crosssectional 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 poststenting and 6month followup) was performed in a predefined 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 sirolimuseluting 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 crosssectional 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 lateacquired 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 sirolimuseluting stents with paclitaxeleluting 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 firstgeneration DES with the potential for improved longterm 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 longterm safety of bare metal stents.”
Source
Judy Romero