Abstract WMP22: Third International Stroke Trial (IST-3): Effect Of iv rt-pa < 6 Hours In Acute Ischaemic Stroke On Living Circumstances And Health Related Quality Of Life At Six Months
Aim: describe the effects of thrombolysis with iv rt-PA < 6hrs on health related quality of life (HRQoL) & living circumstances at 6 months.
Methods: Randomised trial of iv rt-PA (0.9mg/kg) (n=1515) versus control (n=1520). At 6 months, patients were assessed by postal questionnaire or blinded telephone interview to determine living circumstances and HRQoL with the EQ5D-3L (including its visual analogue scale (VAS)(100=best, 0=worst) assessment of overall self-rated health. We: a) calculated the mean between-group difference in VAS self-rated health, b) analysed the 5 3-level domains of EQ5D by ordinal logistic regression. Analyses were adjusted for baseline prognostic factors (age, NIHSS, hours delay from onset to randomisation, and presence of visible ischaemia on the baseline scan). IST-3 is registered ISRCTN25765518.
Results: At 6 months, 408 [27%] vs 407 [27%]allocated rt-PA vs control had died; in survivors, mean VAS was significantly higher, indicating better HRQoL, with rt-PA (60.7 vs 57.8, mean adjusted difference 3.3, p=0.008). Across the 5 3-level domains of the EQ5D, allocation to rt-PA was associated with reduced adjusted proportional odds of having greater problems with: Self-care (odds ratio 0.79, 95% CI 0.66-0.94, p =0.008) and usual activities (0.74, 95% CI 0.63-0.88, p=0.001), but not mobility (0.88, 95% CI 0.74-1.05), anxiety depression (0.94, 95% CI 0.79-1.11) or pain or discomfort (1.01, 95% CI 0.85-1.20). The adjusted mean difference in VAS among patients randomised 0-2, 2-3, 3-4, 4-5, 5-6 hours was: 8.9, 3.5, 2.0, 0.8, 6.2. There was no difference in the proportions living in their own home 805/1058 (76%) vs 799/ 1050 (76%), nor in the proportions living in the home of a relative, in a residential home or a nursing home.
Conclusion: Thrombolysis with iv rt-PA up to six hours after onset was associated with a statistically significant improvement in overall HRQoL in survivors, and the differences applied across a number of clinically significant individual domains. The decline in HRQoL(VAS) benefit with increasing time to randomisation matches the decline in benefit on functional outcome, except for the unanticipated increase at 5-6hrs.
- © 2012 by American Heart Association, Inc.