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The recent BIOFLOW V trial (ClinicalTrials.gov: NCT02389946) showed that the Orsiro ultrathin, bioresorbable-polymer sirolimus-eluting stent (BP SES) (Biotronik, Buelach, Switzerland) had lower rates of both clinically driven target lesion revascularization (TLR) and target vessel-related myocardial infarction (TVMI) at 24-month follow-up than the Xience thin, durable-polymer everolimus-eluting stent (DP EES) (Abbott Vascular, Santa Clara, CA). We simulated the impact on cost and mortality.
We projected the impact of the lower adverse event rates from a U.S. health system perspective over a 48-month horizon with a Markov model. Event rates were derived from BIOFLOW V trial data (Table), and estimates for costs and excess mortality caused by adverse events came from published sources and expert interviews. All cost estimates were CPI-adjusted to 2018 US$ and future cost-discounted by 3%.
We estimate that use of BP SES compared to DP EES was associated with cumulative net reductions in medical cost of $2,637 per patient over 48 months, or $659 per patient-year. Periprocedural TVMI contributed $126 (5%) of cost, of which $115 (91%) accrued to the initial admission. Spontaneous TVMI contributed $1,606 (61%) and TLR in patients without TVMI $905 (34%). Use of BP SES compared to DP EES was associated with relative mortality risk reduction of 2.9% over four years.
Lower adverse event rates of BP SES translate into meaningful reductions in direct medical cost and mortality. Most of the cost reduction is attributed to reduction in spontaneous TVMI.