Key result
Everolimus-eluting stents significantly reduced the 2-year rate of major adverse cardiac events compared to paclitaxel-eluting stents (7.1% vs 12.3%; P=0.0014).
Why the study?
Does an everolimus-eluting stent reduce major adverse cardiac events compared to a paclitaxel-eluting stent in patients with de novo coronary artery lesions?
RCT (n=1,302)
Yes
Does an everolimus-eluting stent reduce major adverse cardiac events compared to a paclitaxel-eluting stent in patients with de novo coronary artery lesions?
Absolute Event Rate: 7.1% vs 12.3%
p-value: p=0.0014
In a pooled analysis of the SPIRIT II and III trials, everolimus-eluting stents significantly reduced 2-year major adverse cardiac events compared to paclitaxel-eluting stents, with robust benefits in reducing target lesion revascularization.
Supports preferring everolimus-eluting over paclitaxel-eluting stents for de novo lesions; confirms and extends RCT evidence on MACE reduction.
AIMS: To investigate the clinical impact of the following observations in the randomized SPIRIT II and III trials: an incremental increase in in-stent neointima between 1 and 2 years with the everolimus-eluting stent (EES) but not with the paclitaxel-eluting stent (PES) in SPIRIT II; a tendency of lower stent thrombosis in EES than in PES among those who first discontinued a thienopyridine after 6 months. METHODS AND RESULTS: A pooled analysis was performed using the 2-year clinical data from the SPIRIT II and III trials randomizing a total of 1302 patients with de novo coronary artery lesions either to EES or to PES. Inclusion and exclusion criteria were comparable between two trials. Major adverse cardiac event (MACE) was defined as cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularization (TLR). At 2 years, MACE rates were 7.1% in EES vs. 12.3% in PES, respectively (log-rank P = 0.0014), without late increase in TLR. Among those who first discontinued a thienopyridine after 6 months, Academic Research Consortium (ARC) definite or probable stent thrombosis was 1.1% in EES vs. 1.3% in PES (P = 1.00). CONCLUSION: The benefits of EES in reducing TLR were robust between 6 months and 2 years. No significant difference in the thrombosis rate among those who first stopped a thienopyridine after 6 months was observed.
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Onuma et al. (2010) conducted an RCT in de novo coronary artery lesions (n=1,302). Everolimus-eluting stent (EES) vs. Paclitaxel-eluting stent (PES) was evaluated on Major adverse cardiac event (MACE) defined as cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularization (p=0.0014). Everolimus-eluting stents significantly reduced the 2-year rate of major adverse cardiac events compared to paclitaxel-eluting stents (7.1% vs 12.3%; P=0.0014).
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