The Efficacy of XIENCE V Stent over Taxus Stent Decreases with Time: Results from the SPIRIT II study
You don't need to be Editor-In-Chief to add or edit content to WikiDoc. You can begin to add to or edit text on this WikiDoc page by clicking on the edit button at the top of this page. Next enter or edit the information that you would like to appear here. Once you are done editing, scroll down and click the Save page button at the bottom of the page.
March 31, 2008 By Alexandra M. Palmer [1]
SCAI-ACCi2 08-Chicago, IL: The 2-year results of the SPIRIT II study demonstrate no significant difference between the outcomes obtained from implantation of the XIENCE V everolimus-eluting stent or the TAXUS paclitaxel-eluting stent.
The SPIRIT II study was a prospective, randomized, single-blind, multicenter study which enrolled 300 patients at 28 centers in Europe, New Zealand and India. Included patients presented with no more than 2 new native coronary artery lesions between 2.5 mm and 4.25 mm in diameter and ≤28 mm in length. 223 patients were randomized to implantation of the XIENCE V Everolimus Eluting Coronary Stent System and 77 to the TAXUS Paclitaxel-Eluting stent.
Previously reported angiographic results of SPIRIT II compared 6-month in-stent late loss between XIENCE V everolimus-eluting stents and TAXUS paclitaxel-eluting stents. In these findings, XIENCE V was favored over TAXUS (0.17 ± 0.32 mm vs. 0.33 ± 0.32 mm, p = 0.0037).
The 1-year clinical results also favor XIENCE V implantation for greater reduction in the total rate of major adverse cardiac events (MACE), including myocardial infarction, cardiac death, and repeat treatment of the culprit lesion (2.7% vs. 9.2%, p = 0.04).
The new 2-year follow-up data were presented by Dr. Patrick W. Serruys at today’s SCAI-i2 summit Annual Scientific Sessions in Chicago.
At 2 years, the pre-specified primary endpoint of angiographic in-stent late loss was not significanttly different between XIENCE V and TAXUS stents (0.33 ± 0.37 mm vs. 0.34 ± 0.34 mm, p = 0.6026). There was no difference between the rate of ≥50% restenosis (2.1% vs. 2.9%) and the rate of stent thrombosis either.
Also at 2 years, the clinical superiority of XIENCE V (n=211) over TAXUS (n=73) was no longer statistically significant. The rate of MACE was 11.0% in the TAXUS group and only 6.6% in patients treated with XIENCE V (p=0.3077). Furthermore, 6.8% of patients with TAXUS stents underwent ischemia driven target lesion revascularization, in comparison to only 3.8% of patients with XIENCE V stents. Myocardial infarction and cardiac death rates tended to be lower in the XIENCE V arm as well (2.8 vs. 5.5% and 0.5 vs. 1.4%).
The results suggest that with time, the superiority of XIENCE V declines. It will be interesting to continue to follow this study as there are still results to come from the 3, 4, and 5-year clinical follow-ups.
Sources
- Patrick W. Serruys, On behalf of the SPIRIT II Investigators. SPIRIT II Study: A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions. As presented at the late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, March 30-April 1, 2008 Chicago
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
