EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
-
Randomized Controlled Trial Multicenter Study Comparative Study
The three year follow-up of the randomised "all-comers" trial of a biodegradable polymer biolimus-eluting stent versus permanent polymer sirolimus-eluting stent (LEADERS).
The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES). ⋯ The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.
-
In patients presenting with a ruptured abdominal aortic aneurysms (AAA), a choice can be made whether or not to offer treatment (selective treatment policy). Patients with a realistic expectation of survival after surgery, identified by several available prediction models, can be offered two treatment options: conventional "open" surgical repair and endovascular "minimally invasive" repair. Conventional open repair carries a significant morbidity and mortality, due to the combined effects of general anaesthesia and surgical exposure. ⋯ However, these mainly observational studies show considerable heterogeneity. Furthermore, potential selection bias, selecting patients for endovascular repair constituting a haemodynamically lower-risk category with a more favourable EVAR suitable anatomic configuration, makes a proper comparison unlikely. Therefore, randomised controlled trials, although difficult to perform in an acute severe condition like ruptured AAA, are needed to identify possible benefits of EVAR over open surgery in patients with a ruptured AAA.