Abbott to Present Comprehensive Safety and Efficacy Data on XIENCEâ„¢ V Drug Eluting Stent to FDA Advisory Committee on November 29
Data in Pre-Market Approval Application Are First Ever to Demonstrate Superiority of One Drug Eluting Stent Over Another in a Randomized Controlled Clinical Trial
New Data Released Confirms Consistency of Results for Late Loss, TVF, MACE, TLR, Cardiac Death, MI, Thrombosis Across all XIENCE V Studies
Abbott Park, Illinois, November 27, 2007 â€” Abbott today released a summary of clinical highlights on the XIENCEâ„¢ V Everolimus Eluting Coronary Stent System, which will be presented November 29 to the Circulatory System Devices Advisory Panel, an advisory committee to the U.S. Food and Drug Administration (FDA). The clinical summary was released in conjunction with the posting of the Panel briefing documents on the FDA Web site (www.fda.gov ). The advisory panel will review the data and recommend if the FDA should approve XIENCE V, a next-generation drug eluting stent for the treatment of coronary artery disease.
"The data we have submitted to the FDA to support the approval of XIENCE V is robust, consistent across several independent randomized trials and shows sustained positive results over time," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "XIENCE V is the only drug eluting stent that has demonstrated clinical superiority over another drug eluting stent in a randomized clinical trial, and we look forward to sharing our data with the FDA Advisory Panel as they review this important new technology for physicians and patients."
New data made available today as part of the Panel documents include two-year safety results from a pooled subset of 603 patients from the SPIRIT II and SPIRIT III trials (422 treated with XIENCE V). Results from this subset are consistent with the positive SPIRIT III one-year data and the pooled analysis of the SPIRIT II and SPIRIT III trials at one year presented last month at TCT 2007. The new two-year subset data analysis shows similar low rates of major adverse cardiac events (MACE), target vessel failure (TVF), cardiac death, heart attack, and stent thrombosis as previously reported in the SPIRIT trials. The pooled two-year subset data also show similar rates of death, myocardial infarction (MI), and late stent thrombosis (31-758 days) between XIENCE V and the TAXUSÂ® Paclitaxel-Eluting Coronary Stent System at two years.
XIENCE V Clinical Program Highlights
During the FDA Advisory Panel meeting, Abbott will present data from across its SPIRIT clinical program. In the SPIRIT family of trials, XIENCE V demonstrated:
Proven superiority in the primary endpoint of in-segment late loss (a measure of vessel renarrowing) in the SPIRIT III clinical trial, with XIENCE V demonstrating a 50 percent reduction in in-segment late loss compared to TAXUS at eight months.
An observed 23 percent reduction in the major secondary endpoint of Target Vessel Failure (retreatment anywhere within the target vessel) compared to TAXUS at one year in SPIRIT III. TVF rates in the pooled SPIRIT II and SPIRIT III analyses were consistent with the SPIRIT III one-year results, with XIENCE V demonstrating an observed 29 percent reduction in TVF at one year in the pooled SPIRIT II and SPIRIT III analysis and an observed 28 percent reduction in TVF at two years in the pooled two-year subset of SPIRIT II and SPIRIT III.
An observed 43 percent reduction in major adverse cardiac events (MACE) compared to TAXUS at one year in SPIRIT III. MACE is an important clinical measure of safety and efficacy outcomes for patients (cardiac death, heart attack, TLR or reintervention). MACE rates in the pooled SPIRIT II and SPIRIT III analyses are consistent with the SPIRIT III one-year results, demonstrating an observed 47 percent reduction in MACE in XIENCE V-treated patients at one year in the pooled SPIRIT II and SPIRIT III analysis and an observed 48 percent reduction in MACE in XIENCE V-treated patients at two years in the pooled two-year subset of SPIRIT II and SPIRIT III.
Similar to SPIRIT III one-year and pooled SPIRIT II and SPIRIT III one-year results, there were low rates of cardiac death, MI and stent thrombosis out to two years in the pooled two-year subset of SPIRIT II and SPIRIT III, with 98.2 percent cardiac death free survival and 97 percent heart attack free survival at two years in patients treated with XIENCE V.
No statistical difference in the rates of late (>30 days) stent thrombosis between XIENCE V and TAXUS at one year in SPIRIT III (0.5 percent XIENCE V vs. 0.6 percent TAXUS, ARC definite/probable definition), at two years in the pooled subset analysis of SPIRIT II and III (0.8 percent XIENCE V vs. 1.3 percent TAXUS, ARC definite/probable definition) or between years one and two in the pooled subset analysis of SPIRIT II and III (0.3 percent XIENCE V vs. 0.0 percent TAXUS, ARC definite/probable definition).
"Across all of the SPIRIT trials, XIENCE V has met its primary and major secondary endpoints, demonstrating either noninferiority or clinical superiority compared to TAXUS, the most widely used drug eluting stent," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, principal investigator of the SPIRIT III clinical trial. "The data out to two years also demonstrate XIENCE V is safe, with low rates of death, heart attack and stent thrombosis, which were comparable to TAXUS, with improved efficacy in terms of freedom from clinical restenosis."
Robust Post-Approval Program
Abbott's robust continued access and post-approval program is projected to enroll more than 14,000 XIENCE V patients across a variety of planned clinical trials. As part of the Panel briefing documents released today, Abbott also outlined plans for its XIENCE V USA trial, a 5,000 patient post-approval trial designed to study safety outcomes such as late stent thrombosis, death, MI and revascularization with follow-up out to five years. The study also will evaluate patient compliance with antiplatelet therapy.
In addition to XIENCE V USA, SPIRIT IV is a 3,690-patient continued access trial that is currently enrolling patients and will evaluate the safety and efficacy of XIENCE V for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is an international clinical trial that will provide additional clinical experience with XIENCE V in approximately 3,000 patients at approximately 100 clinical sites throughout Europe, Asia, Canada and Latin America. XIENCE V SPIRIT WOMEN is the world's first drug eluting stent trial to study only women and will evaluate the characteristics of 2,000 women undergoing stent implantation as well as the performance of XIENCE V in those patients in Europe, Asia-Pacific, Canada and Latin America. Both SPIRIT V and XIENCE V SPIRIT WOMEN are currently enrolling patients.
Abbott filed its Premarket Approval (PMA) submission for XIENCE V with the FDA on June 1, 2007. XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the United States and Japan.
Abbott 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 65,000 people and markets its products in more than 130 countries.