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Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents: A Pooled Analysis From the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials
Study Questions:
What are the long-term 3-year clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES)?
Methods:
In the SPIRIT II and SPIRIT III trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). The investigators reported the 3-year clinical follow-up of this patient-level pooled analysis.
Results:
At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (MI) (3.8% vs. 6.7%; relative risk [RR], 0.56; 95% confidence interval [CI], 0.34-0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR, 0.53; 95% CI, 0.37-0.77; p = 0.001). EES resulted in a significant reduction in target vessel failure (TVF) (13.7% vs. 19.5%; RR, 0.70; 95% CI, 0.54-0.92; p = 0.01), and major adverse cardiac events (MACE) (9.1% vs. 16.3%; RR, 0.56; 95% CI, 0.41-0.76; p = 0.0004). The cumulative rates of Academic Research Consortium–defined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR, 0.64; 95% CI, 0.25-1.68; p = 0.43).
Conclusions:
The authors concluded that EES compared with PES resulted in a significant and persistent reduction in TVF and MACE at 3 years.
Perspective:
This pooled analysis suggests a significant and sustained reduction in TVF and MACE among patients treated with EES compared with PES at 3-year follow-up. Furthermore, EES demonstrated improved efficacy and safety over time, with robust reductions in ischemia-driven target lesion revascularization and target vessel revascularization as well as significant and sustained reductions in MI and composite death or MI. It should be noted that the present study is underpowered to definitively examine low-frequency adverse events such as stent thrombosis, MI, and death and comparative trials with emerging DES are required to determine the optimal platform for specific patient and lesion subtypes, particularly patients with diabetes. Based on available data, and the improved clinical outcomes demonstrated in patients receiving EES compared with those receiving PES, EES is an attractive drug-eluting stent choice for clinicians.
Keywords: Paclitaxel, Risk, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Coronary Vessels, Advisory Committees, Stents
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