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Abbott's XIENCE V(R) Continues to Outperform TAXUS With Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial
Date:9/21/2009

late stent thrombosis at three years was 0.3 percent** for XIENCE V and 1.0 percent for TAXUS (p-value=0.34). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

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, p-value=0.003).
  • 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, p-value=0.005). TLF is a composite measure of important efficacy and safety outcomes for patients, defined as cardiac death, target vessel MI and TLR.
  • 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, p-value=0.03). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, MI or ischemia-driven target vessel revascularization (TVR).
  • 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, p-value=0.07).
  • 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, p-value=0.05).
  • Per protocol definition, a 0.2 percent** rate of very late stent thrombosis compared to 1.0 percent for TAXUS (p-value=0.10). Per ARC definition of definite/probable stent thrombosis, the rate of very late stent thrombosis was 0.3 percent** for XIENCE V and 1.0 percent for TAXUS (p-value=0.34).

Consistent Results in SPIRIT III Subgroup Analyses

In addition to the positive three-year results for the overall study pres
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SOURCE Abbott
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