XIENCE V Everolimus Eluting Coronary Stent System exhibits its advantages over the TAXUS system

Sep 21 2009

Long-term data presented today from the SPIRIT III pivotal U.S. clinical trial demonstrated that the observed clinical advantages of Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System continued to increase as compared to the TAXUS(R) Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS). At three years, XIENCE V demonstrated a 43 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (9.1 percent for XIENCE V vs. 15.7 percent for TAXUS

"The SPIRIT III results clearly demonstrate that at three years, patients continue to benefit from having been treated with the XIENCE V stent rather than the TAXUS stent, with fewer repeat cardiac procedures and fewer heart attacks in patients who received XIENCE V," said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III trial.

XIENCE V demonstrated an impressive low rate of very late stent thrombosis (one to three years) with no additional events between two and three years. Per protocol, XIENCE V demonstrated a 0.2 percent** very late stent thrombosis rate compared to 1.0 percent for TAXUS>

Key Results from SPIRIT III

In the 1,002-patient SPIRIT III trial, XIENCE V demonstrated the following key results out to three years:

• A 43 percent reduction in the risk of MACE compared to TAXUS (9.1 percent for XIENCE V vs. 15.7 percent for TAXUS,>
• A 43 percent reduction in the risk of Target Lesion Failure (TLF) compared to TAXUS (8.3 percent for XIENCE V vs. 14.4 percent for TAXUS,>
• A 30 percent reduction in the risk of Target Vessel Failure (TVF) compared to TAXUS (13.5 percent for XIENCE V vs. 19.2 percent for TAXUS,>
• A 42 percent reduction in the risk of heart attacks (MI) compared to TAXUS (3.7 percent for XIENCE V vs. 6.3 percent for TAXUS,>
• A 39 percent reduction in the risk of ID-TLR compared to TAXUS (5.4 percent for XIENCE V vs. 8.9 percent for TAXUS,>
• Per protocol definition, a 0.2 percent** rate of very late stent thrombosis compared to 1.0 percent for TAXUS>

Consistent Results in SPIRIT III Subgroup Analyses

In addition to the positive three-year results for the overall study presentation, subgroup analyses from the SPIRIT III trial demonstrated evidence of the strong performance by XIENCE V in a variety of patients and lesion types that represent complex patients. In patients with diabetes, the analysis showed there was no difference at three years in MACE between XIENCE V and TAXUS (11.0 percent for XIENCE V vs. 10.3 percent in TAXUS)*** . In fact, XIENCE V maintained a consistent rate of clinical events after the first year (8.7 percent MACE at one year and 11.0 percent MACE at three years), whereas TAXUS demonstrated a sustained upward trend in clinical events from one year to three years (4.7 percent MACE at one year and 10.3 percent MACE at three years). In patients without diabetes, the MACE rate for TAXUS at three years was more than double the MACE rate for XIENCE V at three years (9.1 percent for XIENCE V vs. 18.7 percent for TAXUS).

"The SPIRIT III data clearly show that XIENCE V performs in a consistent manner, with clinical benefits continuing to improve over time compared to TAXUS," said Robert Hance, senior vice president, vascular, Abbott. "We are pleased to begin this year's TCT conference with a strong showing of data for Abbott's market-leading XIENCE V, and look forward to presenting the highly anticipated SPIRIT IV one-year results later this week, which should provide physicians with additional valuable insights."

One-year results from the company's SPIRIT IV trial will be presented on Wednesday, Sept. 23, during the first late-breaking clinical trials session of the TCT conference. The SPIRIT IV trial is one of the largest randomized clinical trials between two drug eluting stents, with 3,690 patients enrolled, including more than 1,000 patients with diabetes. The study results will provide valuable information about the efficacy and safety of XIENCE V compared to TAXUS. The SPIRIT III trial was not designed to analyze statistical differences in any of the patient subgroups, as the sample sizes were too small to draw firm conclusions.

Source: http://www.abbott.com