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17 PROACT II was a randomized controlled trial of intra-arterial  thrombolysis with recombinant prourokinase (r-proUK) plus low-dose  heparin vs. low-dose heparin alone. In the primary outcome analysis,  40% of patients treated with r-proUK and 25% of control patients had  a good neurological recovery at 90 days defined by a modified Rankin  score≤2 (p=.043). Objective: To identify prognostic factors for the  primary outcome measure and determine whether the treatment effect of  r-proUK was consistent across subgroups stratified according to risk.Methods: Twenty-seven baseline categorical variables and 11  quantitative variables were selected. Stepwise logistic regression was  used to identify important prognostic factors and to create a score  which subdivided the study group into risk quartiles. Treatment effect  was calculated as an odds ratio (OR) within each quartile and compared  with a Breslow-Day test.Results: Three baseline variables  were identified as strongly influencing the probability of a good  outcome; Age ≤ 68 (p 20)=0.085, relative to NIHSS≤10). The effect of treatment in the  risk quartiles is summarized in the Table. Comparison of the size of  the treatment effect over risk quartiles was non-significant p=0.91.Conclusion: Despite stratification of patients based on  important prognostic variables there was no evidence of a difference in  treatment effect across risk categories. All PROACT eligible patients  stand to benefit from early intra-arterial r-proUK  treatment.

Factors Influencing Outcome and Treatment Effect in PROACT II