Author + information
- Giulio G. Stefanini,
- Lorenz Raber,
- Masanori Taniwaki,
- Pawel Buszman,
- Axel Linke,
- Thomas Ischinger,
- Bernhard Meier,
- Peter Juni,
- Patrick Serruys and
- Stephan Windecker
The unrestricted use of biodegradable polymer biolimus–eluting stents (BES) has been shown to improve clinical outcomes compared with durable polymer sirolimus–eluting stents (SES) among patients with coronary artery disease in the LEADERS all–comers trial. In response to the FDA guidance document on the evaluation of sex differences in medical device clinical studies, we aimed to investigate the consistency of these findings in female patients.
Out of 1,707 patients included in the LEADERS trial, 430 (25.2%) were women randomly allocated to biodegradable polymer BES (N=214) or durable polymer SES (N=216). Clinical follow–up was completed in 96.1% of patients at 4 years. Clinical outcomes were compared between women treated with biodegradable polymer BES and those treated with durable polymer SES. Analysis was by intention–to–treat. Primary endpoint of the trial was a composite of cardiac death, myocardial infarction (MI), and clinically–driven target vessel revascularization (TVR).
At 4 years, the primary endpoint occurred numerically less frequently in women treated with biodegradable polymer BES compared with durable polymer SES (19.9% vs. 22.5%), however the difference did not reach statistical significance (hazard ratio [HR] 0.86, 95% CI 0.57–1.31). Similar findings were observed for the primary endpoint individual components cardiac death (HR 0.76, 95% CI 0.36–1.62), MI (HR 0.96, 95% CI 0.48–1.89), and TVR (HR 0.93, 95% CI 0.54–1.60), as well as overall definite stent thrombosis (HR 0.67, 95% CI 0.24–1.88) and very late definite stent thrombosis (HR 0.33, 95% CI 0.03–3.21). Noteworthy, the HR point estimates observed in women were favorably comparable with those observed in the overall population included in the LEADERS trial.
The LEADERS trial does not have sufficient power to allow any definitive conclusion for the comparison of biodegradable polymer BES with durable polymer SES among women. However, HR point estimates observed in women were consistent with the main findings of the trial, suggesting a similar safety and efficacy profile of biodegradable polymer BES in women as in the overall population.
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.–10:45 a.m.
Session Title: Coronary Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2101–233
- 2013 American College of Cardiology Foundation