The BASKET study program: continued evaluation of the efficacy and safety of drug-eluting stents

摘要

Since the introduction of clrug-eluting stents (DES) in 2000, there has been much debate whether these more expensive devices are cost effective when compared with bare-metal stents (BMS). The initial enthusiasm in the use of DES due to a markedly reduced rate of restenosis compared with BMS was hampered in the following years by reports of increased rates of late-stent thromboses, which raised the concern about a possible late harm after implantation of a DES. The Basel Stent Kosten-Effektivitats Trial (BASKET) study program was initiated to answer some of these questions in a real-world setting. The original BASKET study tested the cost-effectiveness of DES compared with BMS and found cost-effectiveness of DES in high-risk subgroups only. BASKET Late Thrombotic Events (BASKET-LATE), the observational follow-up study of the randomized controlled BASKET trial, found an increased late harm in large native vessels treated with DES, which was attributed to an increased rate of late-stent thromboses. BASKET-Prospective Validation Examination (BASKET-PROVE) was designed as a prospective randomized trial based on the hypothesis-generating results of BASKET-LATE and did refute this hypothesis, hereby corroborating the safety and efficacy of second-generation DES.