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Circulation Publishes Pivotal Two-Year Results On XIENCE V(TM) Drug Eluting Stent
Date:1/26/2009

acy outcomes for patients, defined as cardiac death, MI or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).

-- A 40 percent reduction in the risk of cardiac death or MI (4.0 percent for XIENCE V vs. 6.6 percent for TAXUS, p-value=0.08)*.

-- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, MI or target vessel revascularization (TVR).

-- A 40 percent reduction in the risk of ischemia-driven target lesion revascularization (ID-TLR) as compared to TAXUS (4.3 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.07)*.

-- Low rates of stent thrombosis (blood clotting within the treated area) per the Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (1.3 percent for XIENCE V vs. 1.7 percent for TAXUS) and per the SPIRIT III protocol (1.0 percent for XIENCE V vs. 1.7 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

-- Among patients who discontinued anti-platelet therapy with a thienopyridine (clopidogrel or ticlopidine) in the study after six months, trends showed that patients treated with XIENCE V experienced fewer stent thromboses compared to those treated with TAXUS at the end of two years (0.4 percent for XIENCE V vs. 2.6 percent for TAXUS).

"XIENCE V continues to demonstrate sustained excellence, and the data demonstrate why it is an important advancement in the treatment of heart disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The consistent positive clinical trial findings, like those from SPIRIT III, are
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SOURCE Abbott
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