COMPOSITE CLINICAL ENDPOINTS: HANDLE WITH CARE?

Sunday, October 24, 2010
Sheraton Hall E/F (Sheraton Centre Toronto Hotel)
Ellen Bohmer, MD, Sykehuset Innlandet Helseforetak, Brumunddal, Norway, Ivar Sønbø Kristiansen, MD, PhD, MPH, University of Oslo, Oslo, Norway and Sigrun Halvorsen, PhD, Ullevål University Hospital, Oslo, Norway

Purpose: The health benefits of early versus later angioplasty (PCI) for STEMI infarction are not fully known. The aim of this study was to estimate a composite clinical endpoint (death, stroke, reinfarction), health-related quality of life (HRQoL) and cost consequences of replacing "conservative" treatment with early PCI in patients living more than 90 minutes travel time away from PCI services.

Method: Patients with STEMI of < 6 h duration and >90 min transfer delays for PCI received thrombolysis and were randomised to either immediate helicopter transfer and early PCI in university hospital (n=134) or conservative treatment in local hospital and later transfer for PCI (n= 132). The composite endpoint was based on pre-defined criteria. HRQoL (Sintonen 15D) and use of health resources were assessed at baseline, 1, 3, 7 and 12 months follow-up. Data on in-patient care, out-patient care, transportations, pharmaceuticals and work absenteeism were collected. The costs of in-patient care were based on a detailed hospital accounting system. Other costs were based on fee schedules and market prices. Bootstrapping with 1000 replications was used to test for differences.

Result: The composite endpoint was observed in 16% of patients with late PCI versus 6% in early PCI (p=0.02), but some of the difference stemmed from reinfarctions of uncertain clinical significance. The QALYs and costs were almost identical (see table).  
  Early invasive Late invasive Mean difference  (95% CI)
Death, stroke, reinfarction 6 % 16 % 10% (3%-17%)
HRQOL at baseline 0.913 0.902 0.011 (-0.011,0.033)
QALYs 0.885 0.870 0.016  (-0.023, 0.055)
Total costs €19047 €17861 €1185 (-€1683, €4167)

Conclusion: The health outcome was better using a composite endpoint, but not when based on HRQOL. The use of composite cardiologic endpoints may warrant caution in decision making.