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Hemostatic Agents: Cost-Effectiveness Issues

This study examines the cost-effectiveness of hemostatic agents, specifically Aprotinin versus EACA, in cardiac surgery. Conducted by Dr. Peter K. Smith and colleagues, the randomized controlled trial involved 163 patients. It evaluates drug costs, complications related to these agents, and overall hospital expenditure. Despite Aprotinin's higher costs, its efficacy in reducing complications such as myocardial infarction and stroke is analyzed, alongside its lifetime cost benefits. The findings provide insights into optimizing hemostatic practices in thoracic surgery.

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Hemostatic Agents: Cost-Effectiveness Issues

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  1. Hemostatic Agents: Cost-Effectiveness Issues Peter K. Smith, MD Professor and Chief Thoracic Surgery Duke University

  2. Tranexamic RCT Cardiac Surgery (n=163) 10 mg/kg (incision)  1 mg/kg/hr Horrow et al. Circulation 1991; 84:2063

  3. Aprotinin vs EACA Efficacy - Demographics Bennett-Guerrero et al. Anesthesiology 1997;87:1373

  4. Aprotinin vs EACA: Efficacy Bennett-Guerrero et al. Anesthesiology 1997;87:1373

  5. Test Dose Loading Dose Pump-Prime Dose 1 ml 200 ml 200 ml Bypass Period Operation Period Constant Infusion 50 ml / h High-Dose Aprotinin Original Administration Regimen Royston et al Lancet 1987 Dec 5;2:1289-91

  6. Aprotinin Dosing Mossinger et al, ATS 1998;65:S45-51

  7. Aprotinin Dosing • Half-dose FDA Regimen B • 1 ml (10,000 KIU) test dose • 100 ml (1,000,000 KIU) loading dose • 100 ml (1,000,000 KIU) pump prime • 25 ml (250,000 KIU) per hour CPB

  8. Aprotinin Dosing Mossinger et al, ATS 1998;65:S45-51

  9. Aprotinin Effect on Survival

  10. Aprotinin and Myocardial Infarction

  11. Aprotinin and Stroke Incidence * *

  12. Cost of Therapy • Drug cost • Cost of storage and administration • Indirect costs • Cost of complications related to the drug • In-Hospital • Lifetime

  13. Cost Savings • Reduction of blood products and their complications • Reduced OR time and incidence of return • Reduction of inflammatory syndrome • Reduction of complications related to the drug • Cardiac team satisfaction • Patient satisfaction

  14. Aprotinin vs EACA - Efficacy/Cost • Prospective randomized double-blind trial • Repeat median sternotomy- CABG, valve, or both • n= 204 • High dose EACA or Aprotinin (on incision) • Efficacy analysis • Cost/benefit analysis (bleeding related costs) Bennett-Guerrero et al. Anesthesiology 1997;87:1373

  15. Aprotinin vs EACA Cost/Benefit • Perspective of the hospital • Bleeding related costs (not charges), e.g. drug, direct & indirect blood product costs, OR time • No differences in other outcomes expected or seen • Costs Aprotinin Rx higher ($1,813 vs $1,088*) • Sensitivity analysis w/ half dose aprotinin- no chg • Threshold value for aprotinin = $486 Bennett-Guerrero et al. Anesthesiology 1997;87:1373

  16. Lifetime Cost of Therapy • Myocardial Infarction Lifetime Costs • ~$25,000 more than matched (age, gender) patients without MI • With an incidence of 1%, 1 of 100 patients would generate $25,000 in total cost; or • $250 per patient per percent MI change • Stroke Lifetime Costs • ~$100,000 more than matched patients without stroke • With an incidence of 1%, 1 of 100 patients would generate $100,000 total cost; or • $1000 per patient per percent stroke change

  17. Cost Effectiveness of Aprotinin • Drug cost is dose dependent and linear • Effects are dose dependent and non-linear • Effects are only well known at the three doses tested in double-blind trials

  18. 8 y = -2.940LOG(x) + 9.802 6 4 Given (Units) Hemostatic Factors 2 0 0 250 500 750 1000 Total Dose of Aprotinin (mg) Aprotinin Dose vs Hemostatic Factors Given Data from US Multicenter Studies for Repeat CABG Surgery

  19. 8 6 4 Given (Units) Hemostatic Factors 2 0 0 250 500 750 1000 Total Dose of Aprotinin (mg) Aprotinin Dose vs Hemostatic Factors vs Cost $1200 $600 Data from US Multicenter Studies for Repeat CABG Surgery

  20. 8 6 4 Given (Units) Hemostatic Factors 2 0 0 250 500 750 1000 Total Dose of Aprotinin (mg) Aprotinin Dose vs Definite MI 10% 5% Data from US Multicenter Studies for All CABG Surgery

  21. 8 6 4 Given (Units) Hemostatic Factors 2 0 0 250 500 750 1000 Total Dose of Aprotinin (mg) Aprotinin Dose vs Mortality 5% 2.5% Data from US Multicenter Studies for All CABG Surgery

  22. 8 6 4 Given (Units) Hemostatic Factors 2 0 0 250 500 750 1000 Total Dose of Aprotinin (mg) Aprotinin Dose vs Stroke Outcome 3% 2% 1% Data from US Multicenter Studies for All CABG Surgery

  23. Randomized Trial Analysis • Resources used (OR time, blood tx, ICU LOS, Total LOS, etc, etc) as well as age, gender and complication rate were analyzed from the randomized patients. • Model developed on Duke 1300 CABG patients with same resources related multivariably to actual cost. • Adjusted model R2=0.74

  24. Randomized Trial Composition

  25. Cost Model Coefficients

  26. Itemized Resources-Primary CABG

  27. Complications-Primary CABG

  28. Randomized Trial Resource Use Data: Primary CABG Transformed to Cost Through Duke Data Model

  29. Cost-Primary CABG

  30. Itemized Resources-Redo CABG

  31. Complications-Redo CABG

  32. Repeat CABG Peri-operative Costs Full Dose Half Dose Placebo Mean CABG Cost Subtotal $27,458† $28,086† $30,910 (Difference from placebo) ($3,452) ($2,825) -- Aprotinin Cost $1,394 $703 -- Total Peri-op. Cost $28,852† $28,789† $30,910 (Difference from placebo) ($2,058) ($2,122) -- Lifetime Stroke Complication $508† $1,295† $4,444 Lifetime AMI Complication $3,351 $4,188 $3,401 Total Lifetime Costs $32,711† $34,272† $38,755 (Difference from Placebo) ($6,044) ($4,483) -- Randomized Trial Resource Use Data: Redo CABG Transformed to Cost Through Duke Data Model

  33. Cost-Redo CABG

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