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Hemostatic Agents: Cost-Effectiveness Issues. Peter K. Smith, MD Professor and Chief Thoracic Surgery Duke University. Tranexamic RCT Cardiac Surgery (n=163) 10 mg/kg (incision)  1 mg/kg/hr. Horrow et al. Circulation 1991; 84:2063. Aprotinin vs EACA Efficacy - Demographics.

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hemostatic agents cost effectiveness issues

Hemostatic Agents: Cost-Effectiveness Issues

Peter K. Smith, MD

Professor and Chief

Thoracic Surgery

Duke University

slide2

Tranexamic RCT Cardiac Surgery (n=163)

10 mg/kg (incision)  1 mg/kg/hr

Horrow et al. Circulation 1991; 84:2063

slide3

Aprotinin vs EACA Efficacy - Demographics

Bennett-Guerrero et al. Anesthesiology 1997;87:1373

slide4

Aprotinin vs EACA: Efficacy

Bennett-Guerrero et al. Anesthesiology 1997;87:1373

high dose aprotinin

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

aprotinin dosing
Aprotinin Dosing

Mossinger et al, ATS 1998;65:S45-51

aprotinin dosing1
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
aprotinin dosing2
Aprotinin Dosing

Mossinger et al, ATS 1998;65:S45-51

cost of therapy
Cost of Therapy
  • Drug cost
  • Cost of storage and administration
  • Indirect costs
  • Cost of complications related to the drug
    • In-Hospital
    • Lifetime
cost savings
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
slide14

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

slide15

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

lifetime cost of therapy
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
cost effectiveness of aprotinin
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
aprotinin dose vs hemostatic factors given

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

aprotinin dose vs hemostatic factors vs cost

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

aprotinin dose vs definite mi

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

aprotinin dose vs mortality

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

aprotinin dose vs stroke outcome

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

randomized trial analysis
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
slide29

Randomized Trial Resource Use Data: Primary CABG

Transformed to Cost Through Duke Data Model

slide33

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