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Cost-Effectiveness in Acute Coronary Syndromes The ACUITY Economic Study. David J. Cohen, M.D., M.Sc. on behalf of the ACUITY Investigators Harvard Clinical Research Institute Beth Israel Deaconess Medical Center Boston, MA Mid America Heart Institute Kansas City, Missouri.

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cost effectiveness in acute coronary syndromes the acuity economic study

Cost-Effectiveness in Acute Coronary SyndromesThe ACUITY Economic Study

David J. Cohen, M.D., M.Sc. on behalf of the ACUITY Investigators

Harvard Clinical Research Institute

Beth Israel Deaconess Medical Center

Boston, MA

Mid America Heart Institute

Kansas City, Missouri

Harvard Medical

School

disclosures
Disclosures

Study Funding – The Medicines Company

Grant Support/Pharma

  • Schering-Plough - Eli Lilly - BMS/Sanofi
  • CV Therapeutics - Baxter

Grant Support/Devices

  • Cordis - Boston Scientific
  • Edwards Lifesciences - Worldheart

Grant Support/Federal

  • NHLBI - NINDS

DJC: 10/06

background

ACUITY Econ

Background
  • Previous studies have demonstrated that parenteral Gp2b/3a inhibitors can substantially reduce ischemic complications in pts with ACS undergoing an early invasive strategy. However, many patients do not currently receive these agents because of concerns about bleeding complications and cost
  • Recently, the ACUITY trial has validated the use of bivalirudin with provisional Gp2b/3a blockade as an anticoagulation strategy for intermediate and high risk patients with ACS
  • The overall cost-effectiveness of this novel strategy is unknown
objectives

ACUITY Econ

Objectives
  • To compare the in-hospital and 30-day costs for high risk patients with ACS using 3 alternative anticoagulation regimens:
    • Heparin/LMWH with Gp2b/3a inhibition
    • Bivalirudin with Gp2b/3a inhibition
    • Bivalirudin monotherapy

2. To determine the impact of both ischemic and bleeding complications on the cost of ACS in contemporary practice

  • To assess the cost-effectiveness (measured as cost per death or MI averted and also cost per life year gained) of the 5 alternative treatment strategies

Stratified by upstream or cath lab initiation

study design first randomization

Medical

management

UFH or

Enoxaparin

+ GP IIb/IIIa

PCI

Bivalirudin

+ GP IIb/IIIa

Angiography within 72h

R*

Bivalirudin

Alone

CABG

Study Design – First Randomization

Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,800)

Moderate-

high risk

ACS

Aspirin in all

Clopidogrel

dosing and timing

per local practice

*Stratified by pre-angiography thienopyridine use or administration

study design second randomization

UFH or Enoxaparin

Medical

management

Routine upstream GPI in all pts

GPI started in CCL for PCI only

PCI

Bivalirudin

Routine upstream GPI in all pts

R

R

GPI started in CCL for PCI only

Bivalirudin

Alone

CABG

Study Design – Second Randomization

Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,800)

Moderate-

high risk

ACS

Angiography within 72h

Aspirin in all

Clopidogrel

dosing and timing

per local practice

economic study methods 1
Economic Study Methods- 1
  • Economic substudy included all U.S. patients (n=7851), analyzed on an intention to treat basis
  • Detailed medical resource utilization collected prospectively for all patients for initial hospitalization and for 30 days after enrollment
  • Hospital billing data collected on ~2500 randomly selected patients as well as on all patients who experienced a major complication (death, MI, repeat revasc, or major bleed)
economic study methods 2
Economic Study Methods-2
  • Study drug costs based on calculated bolus and infusion volumes and current wholesale cost, assuming that any wasted drug would be discarded
  • Cath lab procedure costs based on “bottom up” cost methodology using measured resource utilization (balloons, stents,, wires, etc.) and current unit costs
  • All other inpatient costs based on hospital charge for each item multiplied by cost-center specific cost-to-charge ratio
  • Physician costs based on Medicare Fee Schedule
  • All costs in 2005 US dollars
management strategy
Management Strategy

P=NS for all comparisons

anticoagulant use
Anticoagulant Use

* Among patients who received the drug

anticoagulant costs

Δ $461

Anticoagulant Costs

p<0.001

for overall comparison

$1537

$1315

$976

$896

$515

in hospital ischemic events death mi unplanned revascularization
In-Hospital Ischemic Events: Death/MI/Unplanned Revascularization

P=NS for overall comparison

Heparin + Upstream GPI

Heparin + Cath Lab GPI

Bivalirudin + Upstream GPI

Bivalirudin + Cath Lab GPI

Bivalirudin Alone

acuity scale major bleeding
ACUITY Scale Major Bleeding

P<0.001 for overall comparison

Heparin + Upstream GPI

Heparin + Cath Lab GPI

Bivalirudin + Upstream GPI

Bivalirudin + Cath Lab GPI

Bivalirudin Alone

hospital length of stay trimmed means
Hospital Length of Stay(trimmed means)

P=0.02 for overall comparison

Heparin + Upstream GPI

Heparin + Cath Lab GPI

Bivalirudin + Upstream GPI

Bivalirudin + Cath Lab GPI

Bivalirudin Alone

mean initial hospitalization costs

 $297/pt

 $827/pt

Mean Initial Hospitalization Costs

$15,258

$14,953

$14,423

$14,448

$14,126

p<0.001 for overall comparison

cost savings bivalirudin alone vs heparin upstream gpi

Net Savings $828/pt

Cost Savings(Bivalirudin Alone vs. Heparin + Upstream GPI)

Anticoagulation

Cath LabProcedures

Room/OR/Nursing/Ancillary

MD fees

Total Savings

cost savings bivalirudin alone vs heparin cath lab gpi

Net Savings $297

Cost Savings(Bivalirudin Alone vs. Heparin + Cath Lab GPI)

Anticoagulation

Cath LabProcedures

Room/OR/Nursing/Ancillary

MD fees

Total Savings

index hospital cost difference bivalirudin alone vs heparin upstream gpi

97.6%

Index Hospital Cost Difference: Bivalirudin Alone vs. Heparin + Upstream GPI

Cumulative Probability

Results based on 1000 bootstrap replicates

index hospital cost difference bivalirudin alone vs heparin cath lab gpi

75.5%

Index Hospital Cost Difference: Bivalirudin Alone vs. Heparin + Cath Lab GPI

Cumulative Probability

Results based on 1000 bootstrap replicates

independent predictors of hospital cost
Independent Predictors of Hospital Cost

* Also adjusted for age, gender, and diabetes

Model 2A

summary
Summary
  • Among ~8000 US patients enrolled in the ACUITY trial, anticoagulant-related costs were lowest with heparin + catheterization laboratory initiated GP2b3a inhibition. Bivalirudin monotherapy beginning upstream and continuing through definitive therapy was associated with drug cost increases of ~$400/pt vs. heparin + cath lab initiated 2b3a inhibition.
  • Similar to the overall trial results, in the U.S. cohort, bivalirudin monotherapy resulted in similar rates of ischemic complications and lower rates of major and minor bleeding complications compared with alternative treatment regimens
summary 2
Summary- 2
  • As a result, bivalirudin monotherapy resulted in significant reductions in hospital length of stay and costs for other hospital services compared with heparin + 2b3a inhibition
  • Despite higher drug treatment costs, aggregate hospital costs were lowest with bivalirudin monotherapy, with overall cost savings of ~$300-$800/patient
  • If these findings are maintained at 30-days and 1-year, bivalirudin alone in patients with NSTE-ACS managed with an early invasive strategy should be considered a highly economically attractive antithrombotic regimen compared with the current US standard of care
special thanks
Special Thanks

ACUITY Steering Committee and Operations

  • Gregg Stone, M.D. (PI)
  • Roxanna Mehran, M.D.

The Medicines Company

  • Stephanie Plent, M.D.
  • Anne Marie Galli

HCRI EQOL Group

  • Duane Pinto, M.D.
  • Elizabeth Schneider, M.P.H.
  • Chunxue Shi, M.Sc.
  • Joshua Walczak
  • David Machon
  • Meghan York, M.D.
  • Ronna Berezin, M.P.H.