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.
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