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

Abstract

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/.

Conflict of interest statement

Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: Dr. Windecker has received research grants to the institution from Abbott, Biotronik, Boston Scientific, Biosensors, Medtronic, Edwards, and St Jude. J. Mauri has received research grants from Abbott Vascular. Peter Jüni has received research grants to the institution from Astra Zeneca, Biotronik, Biosensors International, Eli Lilly and The Medicines Company, and serves as unpaid member of the steering group of trials funded by Astra Zeneca, Biotronik, Biosensors, St. Jude Medical and The Medicines Company. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow diagram of patients included in the trial (according to CONSORT 2010).

A total of 455 patients were randomly assigned to treatment with DP-EES (304 patients) or DP-SES (151 patients). Number of patients assessed for elegibility was not available. DP-EES, Durable polymer-everolimus eluting stent; DP-SES, Durable polymer-sirolimus eluting stent.

Fig 2. Cumulative distribution of the primary end point in-stent late lumen loss shown separately for the two stent types.

DP-EES, Durable polymer-everolimus eluting stent = solid line; DP-SES, Durable polymer-sirolimus eluting stent = dashed line.

Fig 3. Stratified analysis of in-stent late lumen loss (LLL).

Two-sided p-values and CIs from linear mixed models with random intercepts at level of patients. BMI, Body mass index; DP-EES, Durable polymer- everolimus eluting stents; DP-SES. Durable polymer-sirolimus eluting stent; LAD, Left anterior descending artery; RVD, Reference vessel diameter.