Clinical Research
Interventional Cardiology
Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents: 2-Year Follow-Up From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV Trial

https://doi.org/10.1016/j.jacc.2011.02.022Get rights and content
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Objectives

We sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up.

Background

In the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis.

Methods

We prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%).

Results

Treatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types.

Conclusions

In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years. (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System; NCT01016041)

Key Words

angioplasty
prognosis
stent

Abbreviations and Acronyms

DES
drug-eluting stent(s)
EES
everolimus-eluting stent(s)
MI
myocardial infarction
PCI
percutaneous coronary intervention
PES
paclitaxel-eluting stent(s)
TLF
target lesion failure
TLR
target lesion revascularization

Cited by (0)

Dr. Stone has served on scientific advisory boards for and received honoraria from Abbott Vascular and Boston Scientific and has served as a consultant for BMS-Sanofi, AstraZeneca, Eli Lilly, Merck, and Medtronic. Drs. Sudhir, Simonton, and Sood are full-time employees at Abbott Vascular. Dr. Applegate has served on advisory boards for and received research grants and honoraria from Abbott Vascular and St. Jude Medical. Dr. Cannon has served on scientific advisory boards for Abbott Vascular, Boston Scientific, and Medtronic and has been a consultant to Abbott Vascular and Boston Scientific. Dr. Cutlip has been a consultant for St. Jude Medical and has received institutional research support from Medtronic. Dr. Kereiakes has served on scientific advisory boards for Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships to disclose.