Previous studies of non-inferiority (SORT-OUT III and V) compared the biodegradable polymer biolimus-eluting stent (BES) with permanent polymer stent and sirolimus-eluting stent (SES) or everolimus-eluting stent (EES), showing no differences, although the data is still contradictory. The aim of this study was to evaluate whether the recently approved BES is not inferior to EES in terms of the rate of target lesion revascularization (TLR) at one year and of death or myocardial infarction within 3 years after stent implantation in clinical practice in the real world.
Methods and results: A non-inferiority multicenter study that compared BES versus EES. We randomized 3,200 patients (1:1) and followed them for three years. The primary end point of effectiveness was TLR at one year and the primary safety end point was death or myocardial infarction within three years. The angiographic primary endpoint was late lumen loss at 8-12 months. No clinical or angiographic differences between the two groups were observed. BES was not inferior in terms of TLR (4.2% versus 4.2% EES / BES, for non-inferiority <0.0001), or late lumen loss (0.03 mm versus 0.06 mm EES / BES, for non-inferiority <0.0001). There was also no difference in all-cause death, myocardial infarction or in-stent thrombosis. In the subgroup analysis no differences were observed.
Conclusions: In this large randomized study, BES was not inferior to EES with respect to TLR at one year and late lumen loss at 8-12 months. The clinical outcomes follow-up at one year in both groups was excellent, with a low rate of TLR and very low rate of stent thrombosis.
Comments: This study provides very interesting results, reinforcing the positive results of the COMPARE III study. However, we must emphasize that TLR at one year was lower than expected due to less complex coronary anatomy, thus allowing a greater margin of non-inferiority.
Masahiro Natsuaki
2013-03-12
Original title: One-year Outcome of a Trial Comparing Second Generation Drug-eluting Stents Using Either Biodegradable Polymer or Durable Polymer: the NOBORITM Biolimus-Eluting versus XIENCETM/PROMUSTM Everolimus-eluting Stent Trial (NEXT).
