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- Title
Transcranial laser therapy for acute ischemic stroke: a pooled analysis of NEST-1 and NEST-2.
- Authors
Huisa, Branko N.; Stemer, Andrew B.; Walker, Michael G.; Rapp, Karen; Meyer, Brett C.; Zivin, Justin A.
- Abstract
Background Neuro Thera 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 m RS 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 m RS 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.
- Subjects
STROKE treatment; LASER therapy; NEUROPROTECTIVE agents; TREATMENT effectiveness; HEALTH outcome assessment; CLINICAL trials
- Publication
International Journal of Stroke, 2013, Vol 8, Issue 5, p315
- ISSN
1747-4930
- Publication type
Article
- DOI
10.1111/j.1747-4949.2011.00754.x