Abstract
BackgroundThe comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.ObjectivesThe 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).MethodsA 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).ResultsAt 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).ConclusionsAmong 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 registrationClinicalTrials.gov NCT01182428.https://clinicaltrials.gov/
Highlights
Early-generation drug-eluting stents (DES) reduced the need for repeat revascularization compared with bare-metal stents (BMS) at the expense of an increased risk of very late stent thrombosis.[1, 2] New-generation DES were conceived to improve vascular healing after stent implantation
The rate of definite stent thrombosis at 12 months was lower in patients treated with durable polymer everolimus-eluting XIENCE stent (DP-EES) (0% vs. 2.0%, p = 0.036)
Atypical symptoms at presentation, higher burden of comorbidities and inadequate awareness of disease, are factors that usually prevent an adequate proportion of female patients with coronary artery disease (CAD) to participate into randomized trials.[8]
Summary
Early-generation drug-eluting stents (DES) reduced the need for repeat revascularization compared with bare-metal stents (BMS) at the expense of an increased risk of very late stent thrombosis.[1, 2] New-generation DES were conceived to improve vascular healing after stent implantation. Large scale randomized trials and meta-analyses showed better outcomes with new-generation DES compared with BMS and early-generation DES.[3,4,5] In these studies, female patients were typically underrepresented.[6, 7] Advanced age, atypical symptoms at presentation, higher burden of comorbidities and inadequate awareness of disease, are factors that usually prevent an adequate proportion of female patients with coronary artery disease (CAD) to participate into randomized trials.[8] a tendency to use less effective treatment in female relative to male patients with CAD has been reported. [9] As consequence, treatment decisions are frequently based on overall outcomes This is the case for the evaluation of coronary stents. The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner
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