一项比较XIENCE依维莫司洗脱支架与CYPHER西罗莫司洗脱支架治疗女性新发冠状动脉病变的随机多中心试验：SPIRIT WOMEN研究。
A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study.
作者信息
Franzone Anna, Zaugg Serge, Piccolo Raffaele, Modena Maria Grazia, Mikhail Ghada W, Ferré Josepa Mauri, Strasser Ruth, Grinfeld Liliana, Heg Dik, Jüni Peter, Windecker Stephan, Morice Marie-Claude
机构信息
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland.
出版信息
PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.
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/.
背景
尚未以随机方式评估不同药物洗脱支架（DES）在女性患者中的对比性能。
目的
SPIRIT女性临床评估试验比较了耐用聚合物依维莫司洗脱XIENCE支架（DP-EES）与耐用聚合物西罗莫司洗脱Cypher支架（DP-SES）在接受经皮冠状动脉介入治疗（PCI）的女性中的效果。
方法
总共455例稳定型CAD女性患者被随机分配接受DP-EES（n = 304）或DP-SES（n = 151）。该试验的有效血管造影结局是首次手术后9个月时支架内晚期管腔丢失（LLL）。次要血管造影终点包括节段内LLL、支架内和节段内二元再狭窄以及直径狭窄百分比。主要临床结局是全因死亡、心肌梗死（MI）或靶血管血运重建（TVR）的复合结局。
结果
在9个月的随访中，分配至DP-EES和DP-SES的患者支架内LLL分别为0.19±0.38 mm和0.11±0.37 mm。两组间支架内LLL差异的单侧上95%CI为0.08 mm，为0.15，因此在预先指定的非劣效性界值0.17 mm之内（非劣效性p = 0.013）。然而，优效性检验显示DP-EES和DP-SES在LLL方面存在临界显著差异（优效性p = 0.
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