Data from SPIRIT IV clinical trial, a large-scale multi-center study of nearly 4,000 patients in the United States, showed that Everolimus-eluting stents ( Xience V ) demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to Paclitaxel-eluting stents ( Taxus ). The trial, which was powered for superiority for clinical endpoints without angiographic follow up, also examined the differences in performance of the two stents in patients with diabetes.

The data are published in the New England Journal of Medicine ( NEJM ).

The primary endpoint of the trial was target-lesion failure ( TLF ) at one year, a composite measure of cardiac death, target-vessel heart attack or ischemia-driven target-lesion revascularization ( TLR ). Major secondary endpoints of the trial were ischemia-driven TLR at one year, and the composite rate of cardiac death or target-vessel heart attack at one year.

For Everolimus-eluting stents, TLF at one year was 4.2%, and for Paclitaxel-eluting stents, TLF was 6.8%, a significant 38% reduction.

At one-year, ischemia-driven TLR was 2.5% for Everolimus-eluting stents and 4.6% for Paclitaxel-eluting stents, a significant 45% reduction.

The composite rates of cardiac death or target-vessel myocardial infarction through one year were not statistically different with the 2 stents ( 2.2% for Everolimus-eluting stents and 3.2% for Paclitaxel-eluting stents ). The one-year rates of myocardial infarction and stent thrombosis, however, were also lower with Everolimus-eluting stents than with Paclitaxel-eluting stents ( 1.9% vs 3.1% for myocardial infarction and 0.17% vs 0.85% stent thrombosis ).

The results were consistent regardless of lesion length, vessel size and the number of lesions treated. However, in the diabetic-patient subgroup, the study found a comparable rate of TLF with both stents, whereas in patients without diabetes, Everolimus-eluting stents reduced TLF by 53% compared to Paclitaxel-eluting stents.

Source: Cardiovascular Research Foundation, 2010

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