2010InterventionCoronary artery disease3687 patients

SPIRIT IV

Therapy group: Drug-eluting stents · Therapy: Everolimus- vs paclitaxel-eluting stent

The everolimus-eluting stent was superior to the paclitaxel-eluting stent, reducing one-year target-lesion failure in a large population.

Published in N Engl J Med (2010)

Question: Are everolimus-eluting coronary stents superior to paclitaxel-eluting stents in terms of clinical events, and not only angiographic findings?
Design: Randomized, phase 3, single-blind trial of 3687 patients at 66 U.S. sites, without routine follow-up angiography.
Population: Patients with coronary artery disease and de novo native coronary lesions treated with stenting.
Intervention: Implantation of an everolimus-eluting stent (XIENCE V).
Control: Implantation of a paclitaxel-eluting stent (TAXUS Express2).
Primary outcome: Target-lesion failure at 1 year, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization.
Results: Target-lesion failure was lower with everolimus than with paclitaxel (4.2% vs. 6.8%; relative risk 0.62; 95% CI 0.46 to 0.82; P=0.001). Stent thrombosis at 1 year was also lower (0.17% vs. 0.85%; P=0.004).
Safety: Myocardial infarction at 1 year was less frequent with everolimus (1.9% vs. 3.1%; P=0.02), as was stent thrombosis (0.17% vs. 0.85%; P=0.004).
Conclusion: The everolimus-eluting stent reduced target-lesion failure at 1 year compared with the paclitaxel-eluting stent, with a consistent effect across subgroups except in patients with diabetes, in whom the difference was not significant.
Why it matters: It provided clinical, not merely angiographic, evidence favoring second-generation everolimus-eluting stents and helped them displace paclitaxel-eluting stents in practice.

Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.

Generated on October 14, 2026

Sources

Original publication on PubMed (PMID 20445180) ↗Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease.
Journal article (DOI) ↗
ClinicalTrials.gov record (NCT00307047) ↗

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