Key result
Among women undergoing percutaneous coronary intervention, the everolimus-eluting stent was non-inferior to the sirolimus-eluting stent for in-stent late lumen loss at 9 months (difference 0.08 mm, p=0.013 for non-inferiority), though it showed a borderline significant increase in late lumen loss (p=0.044 for superiority).
Why the study?
Does a durable polymer everolimus-eluting stent improve angiographic and clinical outcomes compared to a durable polymer sirolimus-eluting stent in female patients undergoing PCI?
RCT (n=455)
Open-label with blinded outcome assessment
2:1
Yes
Does a durable polymer everolimus-eluting stent improve angiographic and clinical outcomes compared to a durable polymer sirolimus-eluting stent in female patients undergoing PCI?
Mean Difference: 0.08 (95% CI 0–0.16)
Absolute Event Rate: 0.19% vs 0.11%
p-value: p=0.013 for non-inferiority; 0.044 for superiority
Supports everolimus-eluting stent use in women post-PCI; extends randomized comparisons to this population.
BACKGROUND: The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner. OBJECTIVES: The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI). METHODS: A total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR). RESULTS: At 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036). CONCLUSIONS: Among women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/.
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Franzone et al. (2017) conducted an RCT in De novo coronary artery lesions (n=455). XIENCE everolimus-eluting stent (DP-EES) vs. CYPHER sirolimus-eluting stent (DP-SES) was evaluated on In-stent late lumen loss (LLL) at 9 months (MD 0.08, 95% CI 0.00 to 0.16, p=0.013 for non-inferiority; 0.044 for superiority). Among women undergoing percutaneous coronary intervention, the everolimus-eluting stent was non-inferior to the sirolimus-eluting stent for in-stent late lumen loss at 9 months (difference 0.08 mm, p=0.013 for non-inferiority), though it showed a borderline significant increase in late lumen loss (p=0.044 for superiority).
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