Transcranial laser therapy for acute ischemic stroke: a pooled analysis of NEST-1 and NEST-2

Abstract

Background: NeuroThera Effectiveness and Safety Trials (NEST) 1 and 2 have demonstrated safety of transcranial laser therapy (TLT) for human treatment in acute ischemic stroke. NEST 1 study suggested efficacy of TLT but the following NEST 2, despite strong signals, missed reaching significance on its primary efficacy endpoint. In order to assess efficacy in a larger cohort, a pooled analysis was therefore performed.

Methods: The two studies were first compared for heterogeneity, and then a pooled analysis was performed to assess overall safety and efficacy, and examined particular subgroups. The primary endpoint for the pooled analysis was dichotomized modified Rankin scale (mRS) 0-2 at 90 days.

Results: Efficacy analysis for the intention-to-treat population was based on a total of 778 patients. Baseline characteristics and prognostic factors were balanced between the two groups. The TLT group (n = 410) success rate measured by the dichotomized 90-day mRS was significantly higher compared with the sham group (n = 368) (P = 0·003, OR: 1·67, 95% CI: 1·19-2·35). The distribution of scores on the 90-day mRS was significantly different in TLT compared with sham (P = 0·0005 Cochran-Mantel-Haenszel). Subgroup analysis identified moderate strokes as a predictor of better treatment response.

Conclusions: This pooled analysis support the likelihood that transcranial laser therapy is effective for the treatment of acute ischemic stroke when initiated within 24 h of stroke onset. If ultimately confirmed, transcranial laser therapy will change management and improve outcomes of far more patients with acute ischemic stroke.

Conflict of interest statement

Conflict of interest

© 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Figures

Figure 1

Allocation of patients for this study (combined NEST 1 and 2)

Figure 2

Primary outcome at 90 days according to scores on the mRS, in the intention to treat analysis. TLT was significantly better than sham by Cochran Maentel Haenszel test p=0.005

Figure 3

Forest plot with unadjusted odds ratios for TLT as compared to sham for the 90 day mRS score of 0 to 2 on subsets of the data defined by categories selected from the baseline characteristics (Time from stroke onset (TFSO) to treatment, history of previous stroke, initial NIHSS and gender). The horizontal lines indicate 95% CIs. P values for each stratum on the right.