Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet, S0140673625005495. https://doi.org/10.1016/S0140-6736(25)00549-5 Dr. Craig S. Anderson et al.
Points
- The OPTIMISTmain trial found low-intensity monitoring after stroke thrombolysis was as safe and effective as the standard high-intensity protocol across 4,515 patients in eight countries.
- Functional outcomes were nearly identical between groups, with 31.7 percent of low-intensity patients and 30.9 percent of standard-monitoring patients experiencing death or disability.
- Rates of symptomatic intracerebral hemorrhage and serious adverse events were similarly low in both groups, showing no significant safety trade-off with reduced monitoring.
- Low-intensity protocols eased pressure on nursing resources without compromising care, making them attractive for hospitals managing staffing or bed shortages.
- These findings support reducing monitoring for eligible stroke patients, particularly in settings where intensive resources are limited or under strain.
Summary
The OPTIMISTmain trial, a multicenter, non-inferiority study, evaluated the safety and effectiveness of low-intensity monitoring compared to the standard high-intensity monitoring protocol for patients with acute ischemic stroke receiving intravenous thrombolysis. The study included 4,515 patients across eight countries and aimed to determine whether reduced monitoring frequency could maintain patient safety while improving nursing workflow and resource utilization. The low-intensity monitoring protocol involved fewer assessments, with patients monitored every 15 minutes for the first 2 hours, every 2 hours for the next 8 hours, and every 4 hours thereafter, compared to the standard protocol’s more frequent checks.
Results showed that the proportion of patients experiencing an unfavorable functional outcome, defined as a modified Rankin Scale score of 2–6 (indicating death or disability), was similar in both groups. In the low-intensity group, 31.7% (809/2552) experienced poor outcomes, compared to 30.9% (606/1963) in the standard monitoring group. The rate of symptomatic intracerebral hemorrhage was low in both groups, with 0.2% in the low-intensity group and 0.4% in the standard group. Serious adverse events occurred in 11.1% of patients in the low-intensity group and 11.3% in the standard group, indicating no significant difference in safety outcomes between the two protocols.
These findings suggest that low-intensity monitoring is non-inferior to standard monitoring in patients with mild to moderate neurological impairment after thrombolysis. This offers a viable alternative to reduce the burden on nursing staff and intensive care resources. The study also demonstrated that low-intensity monitoring could be particularly beneficial in resource-constrained settings, helping hospitals manage capacity without compromising patient outcomes. This approach may become widely adopted in stroke care, especially as healthcare systems face staffing and bed shortages.
Link to the article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00549-5/abstract
References Anderson, C. S., Summers, D., Ouyang, M., Sui, Y., Johnson, B., Billot, L., Malavera, A., Faigle, R., Muñoz-Venturelli, P., Day, D., Liu, X., Li, Q., Song, L., Robinson, T. G., González, F., Urrutia-Goldsack, F., Iacobelli, M., Montalbano, M., Pruski, A., … Del Rio Weldt, A. (2025). Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (Optimistmain): An international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial. The Lancet, S0140673625005495. https://doi.org/10.1016/S0140-6736(25)00549-5
