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SPIRIT IV: Everolimus-eluting stent outperforms paclitaxel-eluting stent in patients without diabetes
Kereiakes D. J Am Coll Cardiol. 2010;56:2084-2089.
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The latest results from the SPIRIT-IV trial have shown everolimus-eluting stents to produce superior clinical outcomes in patients without diabetes, despite both stents performing similarly in patients with diabetes.
“The SPIRIT IV trial confirms and extends the observation made in the SPIRIT III trial of a significant interaction between randomized stent type everolimus-eluting stent (Xience V, Abbott Vascular) vs. paclitaxel-eluting stent (Taxus Express, Boston Scientific) and the presence of diabetes on the primary composite safety-plus-efficacy clinical endpoint,” the researchers wrote.
The randomized, prospective, single blind study included 3,687 patients with up to three de novo native coronary artery lesions who received either an everolimus-eluting stent (n=2,458) or a paclitaxel-eluting stent (n=1,229). Clinical outcomes were analyzed in randomly assigned patients with (n=1,185) and without (n=2,498) diabetes.
One-year results indicated that among patients without diabetes, everolimus-eluting stent vs. paclitaxel-eluting stent reduced the primary endpoint of target lesion failure by 54% (3.1% vs. 6.7%; P<.0001) and major adverse CV events by 52% (3.2% vs. 6.7%; P<.0001). Use of everolimus-eluting stent also resulted in lower rates of the major secondary endpoints of ischemia-driven target vessel revascularization, as well as the composite occurrence of cardiac death or target vessel MI (P=.05).
However, among patients with diabetes, there were no statistically significant differences in outcomes at 1 year between randomly assigned stent types for both target lesion failure and major adverse CV events.
“These findings suggest the need for further studies to elucidate the mechanistic pathways underlying the poor prognosis of patients with diabetes mellitus, with a focus toward development of novel drugs and stents to improve outcomes in this high-risk patient cohort,” the researchers wrote.
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