External validity of the "all-comers" design: insights from the BIOSCIENCE trial.
Franzone A., Heg D., Räber L., Valgimigli M., Piccolo R., Zanchin T., Yamaji K., Stortecky S., Blöchlinger S., Hunziker L., Praz F., Jüni P., Windecker S., Pilgrim T.
OBJECTIVES: We sought to systematically evaluate the external validity of a contemporary randomized controlled stent trial (BIOSCIENCE). METHODS: Baseline characteristics and clinical outcomes of patients enrolled into the BIOSCIENCE trial at Bern University Hospital (n = 1216) were compared to those of patients included in the CARDIOBASE Bern PCI Registry at the same institution (n = 1045). The primary study endpoint was the rate of target lesion failure (TLF), defined as a composite of cardiac death, target vessel-myocardial infarction (MI) or target lesion revascularization (TLR), at 1 year. RESULTS: Women were underrepresented in the RCT compared to the registry (25 vs. 29.4 %, p = 0.020). Non-participants were older compared to study participants (69.2 ± 12.4 vs. 67.0 ± 11.6, p