In addition to functional outcomes, intravenous alteplase administration improved health-related quality of life in patients after an acute ischemic stroke, according to study findings published in Neurology.
Researchers in Europe conducted a post hoc analysis of a multicenter, randomized, placebo-controlled trial, WAKE-UP, (ClinicalTrials.gov Identifier: NCT01525290), which studied the efficacy and safety of intravenous alteplase administration guided by magnetic resonance imaging (MRI) during acute ischemic stroke.
While intravenous alteplase improved functional outcomes according to the modified Rankin Scale (mRS) following acute ischemic strokes, little research reports on patient health-related quality of life following alteplase administration. This post hoc analysis aimed at answering the question if intravenous alteplase extended beyond functional improvements.
The researchers assessed patient health-related quality of life (HRQoL) 90 days after alteplase administration using the patient-reported outcome measure, the EuroQoL 5-dimensional questionnaire (EQ-5D), and the EQ visual analogue scale (VAS). They compared QoL outcomes of 226 stroke survivors treated with alteplase to outcomes of 226 stroke survivors who received placebo.
After 90 days following intravenous alteplase administration, the average scores on the EQ-5D index were higher among patients treated with alteplase than placebo (0.75 vs. 0.67; adjusted mean difference, 0.07; 95% CI, 0.02-0.12; P =.005), indicating better health status.
Average EQ VAS scores were also higher in the alteplase group compared with the placebo group (72.6 vs. 64.9; adjusted mean difference, 7.6; 95% CI, 3.9-11.8; P <.001).
Functional outcomes via the mRS attenuated most of the treatment effect (85%) of alteplase on EQ-5D scores, suggesting less of a direct impact of alteplase on EQ-5D scores.
In contrast, the mRS only attenuated 40% of alteplase’s treatment effect on EQ VAS scores. This indicated that the treatment effect of alteplase directly influenced EQ VAS 60% of the time.
Intravenous alteplase has a beneficial effect on self-reported health-related quality of life.
The researchers concluded that “The effect of intravenous alteplase on subjective unstructured assessment of the current health state by the EQ VAS goes beyond the improvement of functional outcome. These findings indicate the added value of PROMs for assessment of stroke treatment.”
Study limitations included missing data, inability to generalize results to patients with severe strokes, the EQ-5D’s lack of assessment of more QoL domains compared with other functional outcome measures, and use of patient-reported outcome measures which may introduce recall and selection bias to the results.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Jensen M, Sehner S, Cheng B, et al. Patient-reported quality of life after intravenous alteplase for stroke in the WAKE-UP trial. Neurology. Published online October 27, 2022. doi:10.1212/WNL.0000000000201375