Abstract 1949: Are Drug-Eluting Stents Really Worth The Money? Disconnect Between Clinical Trials and Clinical Practice Estimates
Background Enthusiastic reports of DES being cost-effective (CE) compared with BMS derive mostly from clinical trials. However, these reports are based on model assumptions that do not match contemporary “real world” practice estimates. The former are based on 1.4 stent use per case, BMS restenosis (TVR) rate of 14%, and 80% reduction in TVR by DES compared to 1.9 stents per case, BMS TVR of 7.8% and 41% reduction in TVR by DES observed in “real world” BASKET trial.
Objective To perform a sensitivity analysis of CE across BMS TVR, TVR reduction by DES & DES utilization.
Methods Model assumptions:
stent cost differential: $1600;
DES utilization: 1.5 & 2 per case;
100% use of BMS or DES;
attributable cost of restenosis: $20K;
CE threshold: $30K (attributable cost of restenosis + incremental CE ratio <$10K per TVR avoided).
Results (Table⇓) CE of DES is directly related to underlying BMS TVR rate & magnitude of TVR reduction & inversely related to stent use. DES can be considered CE only for TVR> 15–20%, typically seen in small vessels (< 3 mm) and longer lesions (> 15 mm). Thus, underestimation of stent use, overestimation of BMS TVR rate & overestimation of TVR reduction by DES tend to amplify the CE of DES in clinical trials compared to clinical practice.
Conclusion A strategy of “unconditional” substitution of BMS with DES is not cost-worthy. An acceptable strategy is selective initial use of DES in patients at high-risk (TVR rates > 15%) for restenosis (< 20% of stent-eligible patients), “bail-out” use in those who present with clinical restenosis following BMS (< 10–15% of patients), and strict avoidance in those unable or unlikely to comply with long-term antiplatelet therapy (to avoid life-threatening late stent thrombosis). This restricted strategy is judicious, evidence-based and fiscally responsible.