Abstract
Background: Current guidelines recommend use of antiplatelet agents (oral P2Y12 inhibitors and/or GPIIb/IIIa inhibitors) in combination with antithrombin agents (bivalirudin or heparins) for PCI. Cangrelor, a new, intravenous, rapid on/off-set P2Y12 inhibitor reduced ischemic events vs. clopidogrel in the CHAMPION PHOENIX Trial. An economic substudy, from the perspective of the US healthcare system, was designed utilizing a sample of the US trial patients to identify the direct medical costs during index hospitalization among cangrelor vs. clopidogrel patients and the subgroup receiving bivalirudin as antithombin therapy during PCI. Methods and Results: Hospital bills were collected from a proportion of US patients in the CHAMPION PHOENIX trial. All US hospitals (n=53) were invited and 22 participated. Hospital bills were matched to clinical data from the CHAMPION PHOENIX trial endpoints including death, myocardial infarction (MI), unplanned revascularization, stent thrombosis, intraprocedural thrombotic complications, and major bleeding. Events were adjudicated by a blinded, independent committee using predefined criteria. A total of 1117 hospital bills (27.3% of US mITT population) were collected and analyzed. Patient demographics and comorbidities were similar to the overall CHAMPION PHOENIX US mITT population. Hospital costs were determined by multiplying itemized hospital charges and the cost-center specific cost-to-charge ratio obtained from hospital's Medicare cost report. Median index hospitalization costs for patients receiving cangrelor vs. clopidogrel were compared. Statistical significance was assessed using a Wilcoxon Sum-Rank test at a significance level of P<0.05. The median index hospitalization cost of patients receiving cangrelor (N=560) was $10308 vs. $10738 with clopidogrel (N=557) (P = NS), a numerical savings of $430. The median index hospitalization cost of patients receiving both cangrelor/bivalirudin (N=383) was $11139 vs. $11661 with clopidogrel/bivalirudin (N=389) (P = NS), a numerical savings of $522. There was no difference in the mean length-of-stay. MI (Δ$4675), stent thrombosis (Δ$7881), intraprocedural stent thrombosis (Δ$9342), and ACUITY major bleeding (Δ$6181) were associated with increased cost of hospitalization regardless of treatment (all p<0.05). Conclusions: This preliminary analysis of hospital bills from a subset of the CHAMPION PHOENIX US mITT population reveals a numerical reduction in direct medical costs for cangrelor patients (with or without bivalirudin). As these data represent a proportion of the population in a trial of very low event rates, further analysis is necessary utilizing multiple imputation methodology, and regression modeling to provide more robust data to identify factors associated with increased index hospitalization costs among the entire CHAMPION PHOENIX US mITT population.
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