n acute ischemic stroke, minor neurological deficit, defined as a score of 5 or less on the US National Institutes of Health Stroke Scale (NIHSS), is a common occurrence. However, one-third of these patients face the risk of disability and/or death after 90 days. Despite this, evidence confirming the clinical benefit of acute revascularization achieved with intravenous thrombolytic therapy remains inconclusive.
To resolve this clinical dilemma, a large-scale, multicenter study investigated whether tenecteplase (a fibrinolytic agent) improves functional outcomes in this specific population. The resulting clinical outcomes may lead to a significant change in the stroke management algorithm.
The TEMPO-2 Study
The TEMPO-2 study involved 884 adult patients who had confirmed intracranial artery occlusion or cerebral perfusion deficit by imaging studies. They were randomly divided into two groups:
Intravenous Tenecteplase.
Standard Management (without thrombolysis within the first 12 hours).
The main objective of the study was to determine whether tenecteplase would increase the rate of achieving a baseline functional state after three months in patients.
Assessment of Benefit: Tenecteplase overall did not show additional benefit compared to standard treatment in patients who had mild stroke symptoms determined by objective criteria (according to the NIHSS scale).
Functional Outcome: Functional recovery rates (Modified Rankin Scale scores) were similar between the groups after 90 days.
Hemorrhagic Complications: The use of tenecteplase was associated with a higher incidence of hemorrhage. It is noteworthy that symptomatic intracranial hemorrhages (ICH) were particularly frequent in patients who had symptoms causing severe disability.
Additional Results and Recanalization: No significant statistical difference was observed between the groups in terms of functional independence. Although the restoration of blood flow (recanalization) was better in some subgroups after the use of tenecteplase, this did not lead to an improvement in clinical condition.
Based on this data, assessing a disability-causing stroke with objective neurological severity scale scores (and not only by the doctor’s subjective assessment) facilitates the standardized treatment of patients. This research is critical for optimizing stroke management guidelines. Its results contribute to the accurate assessment of the risk-benefit of treatment, thereby reducing harm to patients caused by medical intervention.
Source: JAMA Neurology
