Correspondence

Tissue Plasminogen Activator for Acute Ischemic Stroke

N Engl J Med 1999; 341:1240-1241October 14, 1999

Article

To the Editor:

Kwiatkowski and colleagues (June 10 issue)1 report one-year outcomes of the National Institute of Neurological Disorders and Stroke (NINDS) trial of recombinant tissue plasminogen activator (t-PA) for the treatment of stroke. The treatment (thrombolytic drug or placebo) was given once during the first three hours after the onset of stroke. How were patients in the t-PA and placebo groups treated during the subsequent year? Their treatment was probably affected by the results of vascular testing for the cause of the strokes and by the early outcome. The outcome at one year must have been affected by the cause of the initial stroke as determined by cardiac, cerebrovascular, and hematologic testing and by subsequent treatment. Without information about subsequent evaluation and treatment, it is impossible to know how much of the improvement in outcome at one year, if any, is attributable to the initial thrombolytic therapy. Not only do the authors not mention treatment after the first day, but they do not even comment on this factor as a limitation of the data presented.

Louis R. Caplan, M.D.
Beth Israel Deaconess Medical Center, Boston, MA 02215

1 References

1. 1

   Kwiatkowski TG, Libman RB, Frankel M, et al. Effects of tissue plasminogen activator for acute ischemic stroke at one year. N Engl J Med 1999;340:1781-1787
   Full Text | Web of Science | Medline

Author/Editor Response

The authors reply:

To the Editor: We thank Dr. Caplan for his interest in our study. As stated in our Methods section, after the first 24 hours, treatment was determined by the patient's physician. In addition, all the medical personnel involved in the patient's care remained unaware of treatment assignment (t-PA or placebo) for the year after enrollment. Although we did not collect data on subsequent treatment for the full year, we did collect prospective, blinded data for the first three months. There were no significant differences between the groups with regard to carotid endarterectomy, use of anticoagulant or antiplatelet agents, treatment for newly diagnosed hypertension, or hospitalization for any cause (Table 1Table 1Events and Therapy during the Three Months after Randomization in the NINDS Recombinant Tissue Plasminogen Activator Stroke Trial.). Although these categories do not cover every potential event or treatment, they reflect many of the critical factors that influence the outcome of stroke.

Since we did not systematically collect data with regard to subsequent evaluation and treatment for the entire year after randomization, we agree that we cannot conclude that all our patients received similar therapy during this period. However, the fact that the beneficial effects of t-PA were seen early and were persistent for one year strongly suggests that the improved outcome in our patients was due to treatment with t-PA.

Thomas K. Kwiatkowski, M.D.
Richard B. Libman, M.D.
Long Island Jewish Medical Center, New Hyde Park, NY 11040

for the NINDS Recombinant Tissue Plasminogen Activator Stroke Study Group

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