Pozitívne klinické výsledky XIENCE V

3.4. 2011
Analýza dát z viacerých klinických štúdií týkajúcich sa DES, potvrdila pozitívne klinické výsledky XIENCE V®  od Abbott

Analysis of Data Across Multiple Drug Eluting Stent Trials Reinforces Positive Clinical Performance of XIENCE V®

New Orleans — A pooled analysis of the SPIRIT II, III, IV and COMPARE trials presented today further reinforces the positive clinical performance of Abbott's (NYSE: ABT) market-leading XIENCE V® Everolimus Eluting Coronary Stent System. As part of the analysis of all four trials, two-year results on the safety and efficacy of XIENCE V compared to TAXUS® Liberte® and TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent Systems (TAXUS) were presented at the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.

In a presentation given by Dean J. Kereiakes, M.D., medical director of The Christ Hospital Heart and Vascular Center in Cincinnati, Ohio, predictors of artery re-blockage, cardiac death or heart attack were evaluated out to two years in nearly 7,000 patients from the SPIRIT II, III, IV and COMPARE clinical trials. The data demonstrated that use of XIENCE V resulted in significantly lower clinical event rates following a stent procedure. In the pooled analysis, XIENCE V demonstrated a 36 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V versus 11.1 percent for TAXUS, p-value<0.001). MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or retreatment of a lesion (ischemia-driven target lesion revascularization, or ID-TLR).

"XIENCE V consistently demonstrated low adverse cardiac event rates in trial after trial," said Dr. Kereiakes. "The SPIRIT II, III, IV, and COMPARE pooled analysis suggests that XIENCE V reduced the occurrence of adverse events compared to patients treated with the TAXUS stent. The low event rates demonstrated by XIENCE V in these trials are especially impressive given the complexity of patients in the SPIRIT IV and COMPARE trials and confirm that the results seen with XIENCE V in earlier randomized clinical trials are consistent with clinical practice."

XIENCE V Shows Positive Results in Data Presented at ACC

In addition to the 36 percent reduction in the risk of overall MACE compared to TAXUS, data also were presented at ACC from the pooled analysis that demonstrated the following for XIENCE V:

• A 47 percent reduction in the risk of heart attack (2.9 percent for XIENCE V versus 5.5 percent for TAXUS, p-value<0.001)
• A 40 percent reduction in the risk of cardiac death or heart attack (4.0 percent for XIENCE V versus 6.6 percent for TAXUS, p-value<0.001)
• A 36 percent reduction in the risk of ID-TLR (4.1 percent for XIENCE versus 6.6 percent for TAXUS, p-value<0.001)
• A 70 percent reduction in the risk of stent thrombosis, defined as definite or probable according to ARC (Academic Research Consortium) (0.7 percent for XIENCE V vs. 2.3 percent for TAXUS, p-value<0.0001)

"The pooled analysis of the SPIRIT II, III, IV and COMPARE trials further supports the strong body of clinical evidence that has made XIENCE V a leading drug eluting stent technology for patients and physicians," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "XIENCE V's long-term clinical performance is backed by clinical data from more than 30,000 patients worldwide."

The SPIRIT trials were sponsored and conducted by Abbott. SPIRIT IV included 3,690 patients, many of whom presented with multiple medical complexities, including more than 1,100 patients with diabetes, and patients with small vessels, long lesions, and multiple lesions. The COMPARE study was a physician-initiated trial involving 1,800 patients with complex vascular disease. This pooled analysis was performed independently of Abbott. TAXUS Liberte was the control in COMPARE and TAXUS Express2 was the control in SPIRIT II, SPIRIT  III and SPIRIT IV.

About Xience V

Abbott's market-leading XIENCE V drug eluting stent is marketed in the United States, Europe, Japan and other international markets.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available online at www.xiencev.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.