Decision Analytic Markov Model Weighting Expected Benefits and Current Limitations of First-Generation Bioresorbable Vascular Scaffolds: Implications for Manufacturers and Next Device Iterations.

BACKGROUND: Relative benefits of bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents (EES) are expected to accrue after complete bioresorption.

METHODS AND RESULTS: We built a decision analytic Markov model comparing BVS and EES for a contemporary percutaneous coronary intervention population. Procedure-related morbidity and outcome data from the available literature were used to derive model probabilities. The net benefit of BVS and EES was estimated in terms of quality-adjusted life expectancy. Under the assumption of no risk for device thrombosis and target lesion revascularization with BVS beyond 3 years, the equipoise in quality-adjusted life expectancy (12.86) between BVS and EES was achieved 19 years after implantation. The maximum tolerable excess risk of 3-year BVS thrombosis equalizing the model-predicted quality-adjusted life expectancy of BVS and EES at 10 years was 1.40, corresponding to an absolute tolerable rate of 1.45%.

CONCLUSIONS: At the currently observed relative increase in device thrombosis and under the extreme hypothesis of no scaffold thrombosis and target lesion revascularization beyond 3 years, the incremental benefit of BVS over EES becomes apparent only after 19 years. This simulation suggests that there is a small degree of benefit that clinicians and decision-makers may expect from the first-generation BVS at the current risk of device thrombosis. Manufacturers should target scaffold thrombosis rates <1.45% at 3 years to make their technologies attractive during a 10-year horizon.