New Data Reinforces Safety Profile of Abbott's Market-Leading XIENCE V(R) Drug Eluting Stent

PARIS, May 25 /PRNewswire-FirstCall/ -- Two late-breaking clinical trials presented today at the EuroPCR 2010 conference reinforced the outstanding clinical data supporting Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System. In the XIENCE V USA study of more than 5,000 real-world, complex patients, XIENCE V demonstrated a low rate of blood clots (stent thrombosis) at one year (0.84 percent per Academic Research Consortium [ARC] definition of definite/probable stent thrombosis). In a subset of approximately 1,800 less complex patients (referred to as "standard risk"), XIENCE V demonstrated a one-year stent thrombosis rate of 0.34 percent per ARC definition of definite/probable stent thrombosis.

"The low stent thrombosis rate demonstrated by XIENCE V is impressive given the complexity of the patient population included in the XIENCE V USA trial, and confirms that the stent thrombosis results seen with XIENCE V in earlier randomized clinical trials are consistent in real-world clinical practice," said James Hermiller, M.D., director of Cardiovascular Interventions, St. Vincent Hospital in Indianapolis, Ind., and principal investigator of the XIENCE V USA trial.

The XIENCE V USA study also showed that stent thrombosis rates remained low even when dual anti-platelet therapy (DAPT) was temporarily or permanently discontinued. In the overall XIENCE V USA population, patients who interrupted DAPT usage after six months showed a subsequent late stent thrombosis rate of zero percent. In the subset of standard risk patients, those who interrupted DAPT usage after 30 days also showed a subsequent late stent thrombosis rate of zero percent. DAPT compliance in the XIENCE V USA study was 79.4 percent at one year.  

XIENCE V USA is a post-market, single-arm registry evaluating outcomes in 5,054 XIENCE V patients based in the United States with follow-up out to five years. The study is designed to examine the safety of the XIENCE V stent in an all-comers patient population from real-world clinical settings. The standard risk subset included 1,827 patients. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by ARC. The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials. Mitch Krucoff, M.D., FACC, FCCP, director, Cardiovascular Devices Unit, Duke Clinical Research Institute in Durham, N.C., is co-principal investigator of the XIENCE V USA trial.

XIENCE V Superior to TAXUS in Primary Endpoint of SPIRIT V Diabetes Trial

Abbott also presented data today from the SPIRIT V Diabetes study, an international randomized clinical trial comparing XIENCE V to the TAXUS® Liberte™ Paclitaxel-Eluting Coronary Stent System (TAXUS) in 324 patients with diabetes. In the trial's primary endpoint of in-stent late loss(1), XIENCE V demonstrated superiority to TAXUS (0.19 mm for XIENCE V vs. 0.39 mm for TAXUS; p=0.0001). In-stent late loss is a measure of vessel re-narrowing after a stent procedure.

The SPIRIT V Diabetes trial also showed encouraging observational evidence of low event rates for diabetic patients treated with XIENCE V including:

• In the composite endpoint of cardiac death, heart attack attributed to the treated vessel (target vessel myocardial infarction) and ischemia-driven target lesion revascularization (TLR), XIENCE V demonstrated an observed 10 percent reduction compared to TAXUS (11.2 percent for XIENCE V vs. 12.5 percent for TAXUS, p-value=0.71*).
• In the composite endpoint of cardiac death and target vessel myocardial infarction (MI), XIENCE V demonstrated an observed 61 percent reduction compared to TAXUS (3.7 percent for XIENCE V vs. 9.6 percent for TAXUS, p-value=0.04*).
• In the endpoint of cardiac death, XIENCE V demonstrated an observed rate of 0.5 percent compared to 2.9 percent for TAXUS (p-value=0.10*).
• In the endpoint of ischemia-driven TLR, XIENCE V demonstrated an observed rate of 8.4 percent compared to 3.8 percent for TAXUS (p-value=0.16*).
• In the endpoint of target vessel MI, XIENCE V demonstrated an observed rate of 2.8 percent compared to 8.7 percent for TAXUS (p-value=0.04*)
• In the endpoint of stent thrombosis, XIENCE V demonstrated zero cases of blood clots (ARC definite/probable stent thrombosis) at one year compared to 1.9 percent for TAXUS (p-value=0.11*).

The clinical outcomes from the SPIRIT V Diabetes trial are observational as the trial was not powered to analyze statistical differences in any of the clinical endpoints.

XIENCE V and Abbott's next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System are approved for the treatment of patients with diabetes in CE Mark (Conformite Europeenne) countries. XIENCE PRIME is an investigational device in the United States and is not available for sale.

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 an anti-proliferative drug licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

In the United States, 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 www.abbottvascular.com/en_US/content/document/eIFU_XienceV.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.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.  

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

(1) In the SPIRIT V Diabetes trial, the primary endpoint of in-stent late loss was pre-specified for superiority testing.

* P-values are for descriptive purposes only.

SOURCE Abbott