Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial

Earlier-generation drug-eluting stents (DES) were highly effective in reducing in-stent neointimal formation and therefore the occurrence of restenosis (1). However, there are some concerns about a related thrombogenic response, leading to late and very late stent thrombosis (ST) (2). Permanent polymers have been implicated in suboptimal polymer biocompatibility, persistent inflammatory reaction, and delayed healing observed after DES (3,4). In addition, thick-strut stents, such as first-generation DES, have been demonstrated to be more thrombogenic than identical thin-strut comparators in ex vivo and experimental models (5)