Key result
Everolimus-eluting stents showed similar rates of the primary composite endpoint of death, nonfatal MI, or target-vessel revascularization compared to sirolimus-eluting stents in routine clinical practice (adjusted HR 0.96).
Why the study?
Does the use of everolimus-eluting stents compared to sirolimus-eluting stents improve the composite of death, nonfatal MI, or TVR in patients undergoing percutaneous coronary intervention?
Cohort (n=6,166)
Yes
Does the use of everolimus-eluting stents compared to sirolimus-eluting stents improve the composite of death, nonfatal MI, or TVR in patients undergoing percutaneous coronary intervention?
Hazard Ratio: 0.96 (95% CI 0.82–1.12)
Absolute Event Rate: 12.1% vs 12.4%
p-value: p=0.60
In contemporary PCI practice, the unrestricted use of everolimus-eluting and sirolimus-eluting stents resulted in similar 2-year rates of death, MI, target-vessel revascularization, and stent thrombosis.
Similar 2-year outcomes with everolimus- versus sirolimus-eluting stents in routine PCI; leaves open need for randomized confirmation in broader populations.
BACKGROUND: It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. METHODS AND RESULTS: We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75). CONCLUSIONS: In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.
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Park et al. (2012) conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=6,166). Everolimus-eluting stents vs. Sirolimus-eluting stents was evaluated on Composite of death, nonfatal myocardial infarction, or target-vessel revascularization (HR 0.96, 95% CI 0.82-1.12, p=0.60). Everolimus-eluting stents showed similar rates of the primary composite endpoint of death, nonfatal MI, or target-vessel revascularization compared to sirolimus-eluting stents in routine clinical practice (adjusted HR 0.96).