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Sunday, October 11, 2009 8:06:52 PM
More on Xience vs Taxus from TCT 2009
In addition to 3-year follow-up from the pivotal SPIRIT III study (#msg-41731638) and the first head-to-head data showing Xience outperformed Taxus Liberté (#msg-41855797), ABT reported data at TCT from the SPIRIT IV trial, which was a large (almost 4,000 patients) “real world” head-to-head study of Xience vs Taxus.
Real world in this context means that patients in SPIRIT IV did not have angiographic follow-up for asymptomatic conditions, as they did in the pivotal SPIRIT III study. Thus, instead of the SPIRIT III primary endpoint of late loss (which obviously requires angiographic follow-up), the primary endpoint in SPIRIT IV was Target Lesion Failure (TLF) at one year. TLF was defined as a composite of cardiac death, MI in the target vessel, and revascularization of the target vessel. (TLF is thus more specific to the target lesion than the usual MACE endpoint used in PCI studies, which includes non-fatal MI’s regardless of the triggering locations.)
The image above shows the SPIRIT IV Kaplan-Meier curves for the TLF primary endpoint. The HR was a stellar 0.61 and the p-value was 0.0008.
Source: http://www.xiencev.com/documents/spirit_iv_1year.pdf
In addition to 3-year follow-up from the pivotal SPIRIT III study (#msg-41731638) and the first head-to-head data showing Xience outperformed Taxus Liberté (#msg-41855797), ABT reported data at TCT from the SPIRIT IV trial, which was a large (almost 4,000 patients) “real world” head-to-head study of Xience vs Taxus.
Real world in this context means that patients in SPIRIT IV did not have angiographic follow-up for asymptomatic conditions, as they did in the pivotal SPIRIT III study. Thus, instead of the SPIRIT III primary endpoint of late loss (which obviously requires angiographic follow-up), the primary endpoint in SPIRIT IV was Target Lesion Failure (TLF) at one year. TLF was defined as a composite of cardiac death, MI in the target vessel, and revascularization of the target vessel. (TLF is thus more specific to the target lesion than the usual MACE endpoint used in PCI studies, which includes non-fatal MI’s regardless of the triggering locations.)
The image above shows the SPIRIT IV Kaplan-Meier curves for the TLF primary endpoint. The HR was a stellar 0.61 and the p-value was 0.0008.
Source: http://www.xiencev.com/documents/spirit_iv_1year.pdf
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