Data Indicates Abbott's XIENCE V Stent Patients Are at Lower Risk of Death, Heart Attack

 

October 14, 2008

October 13, 2008 — Data from an independent meta-analysis of Abbott Vascular’s SPIRIT II and SPIRIT III randomized clinical trials demonstrated that the XIENCE V Everolimus Eluting Coronary Stent System continues to deliver clinically significant benefits for patients compared to the TAXUS paclitaxeleluting coronary stent system out to two years, said Abbott.

In this meta-analysis, which included patients from the U.S., Europe and Asia-Pacific, XIENCE V demonstrated clinical superiority to TAXUS in the endpoints of target vessel failure (TVF) and major adverse cardiac events (MACE) at two years.

XIENCE V also demonstrated significantly lower clinical events rates than TAXUS in the key efficacy (target lesion revascularization) and safety (cardiac death or heart attack) components of MACE at two years. The results are being presented by Gregg W. Stone, M.D., principal investigator of the SPIRIT III trial, at TCT 2008.

The meta-analysis of 1,302 patients from the SPIRIT II and SPIRIT III trials demonstrated the following key results for XIENCE V at two years:

• A clinically significant 31 percent reduction in the risk of ischemia-driven Target Vessel Failure (TVF, cardiac events related to the treated vessel) compared to TAXUS (10.4 percent for XIENCE V vs. 14.7 percent for TAXUS, p-value=0.03)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).


• A clinically significant 45 percent reduction in the risk of ischemia-driven major adverse cardiac events (MACE) compared to TAXUS (7.1 percent for XIENCE V vs. 12.3 percent for TAXUS, p-value=0.001)°Ø. 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 ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).

• An observed 28 percent reduction in the risk of all-cause death compared to TAXUS (2.4 percent for XIENCE V vs. 3.3 percent for TAXUS, p-value=0.36)*.

• An observed 28 percent reduction in the risk of cardiac death compared to TAXUS (0.9 percent for XIENCE V vs. 1.3 percent for TAXUS, p-value=0.56)*.

• A clinically significant 45 percent reduction in the risk of heart attack (MI) compared to TAXUS (3.1 percent for XIENCE V vs. 5.6 percent for TAXUS, p-value=0.03)*.

• A clinically significant 39 percent reduction in the risk of all-cause death or heart attack (MI) compared to TAXUS (5.1 percent for XIENCE V vs. 8.3 percent for TAXUS, p-value=0.03)*.

• A clinically significant 41 percent reduction in the risk of cardiac death or heart attack (MI) compared to TAXUS (3.8 percent for XIENCE V vs. 6.3 percent for TAXUS, p-value=0.04)*.

• A clinically significant 41 percent reduction in the risk of ischemia-driven target lesion revascularization (ID-TLR) compared to TAXUS (4.1 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.03)*.

* - Event rates are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.

• Low rates of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.5 percent for XIENCE V and 0.8 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

Also presented during TCT 2008, a variety of subgroup analyses from the SPIRIT III trial demonstrated observational evidence of strong performance by XIENCE V in a variety of patients and lesion types that represent complex patients. The results consistently favored XIENCE V compared to TAXUS at two years across multiple subgroups examined, including patients with small vessels and multi-vessel patients. In diabetic patients, the analysis showed there were no observed differences between XIENCE V and TAXUS at two years. 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.

For more information: www.abbott.com