Clinical Research
Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease: Final 3-Year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)

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Objectives

This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes.

Background

Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up.

Methods

We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis.

Results

At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other).

Conclusions

In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.

Key Words

everolimus
paclitaxel
restenosis

Abbreviations and Acronyms

EES
everolimus-eluting stent(s)
LAD
left anterior descending
MACE
major adverse cardiac events
MI
myocardial infarction
PCI
percutaneous coronary intervention
PES
paclitaxel-eluting stent(s)
TLF
target lesion failure
TLR
target lesion revascularization

Cited by (0)

The SPIRIT II, III, and IV trials were sponsored and funded by Abbott Vascular. Dr. Dangas has reported that his spouse has received honoraria for serving on the advisory board of Abbott Vascular and Boston Scientific. Dr. Kereiakes has received consulting fees from Abbott Vascular, Boston Scientific, and REVA Medical. Dr. Hermiller has received consulting fees from Abbott Vascular and Boston Scientific. Dr. Sudhir, Dr. Smith, and Ms. Cao are full-time employees of and have stock and/or options in Abbott Vascular. Dr. Cutlip has received research support paid to his institution from Medtronic, Abbott Vascular, and Boston Scientific; and has received consulting fees from St. Jude Medical, Stentys, and Celonova. Dr. Stone has received consulting fees from Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.