Effectiveness of Early Stroke Thrombolysis Confirmed in Community-Based Study — Physician’s First Watch

Medical News |
June 3, 2014

Effectiveness of Early Stroke Thrombolysis Confirmed in Community-Based Study

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and André Sofair, MD, MPH

The effectiveness of early thrombolytic therapy after acute stroke observed in randomized trials persists in everyday clinical practice, according to a large, population-based study in BMJ.

Using a German stroke registry, researchers studied nearly 85,000 patients who were treated for acute ischemic stroke from 2008 to 2012. Some 12% of patients received thrombolytic therapy (recombinant tissue plasminogen activator), and the rest did not.

Patients' likelihood of achieving a favorable outcome on the modified Rankin scale increased significantly as the time to thrombolysis decreased. The number of patients who needed to be treated to achieve one favorable outcome was 4.5 when thrombolysis was given within 1.5 hours of stroke onset, rising to 18 when given 3-4.5 hours after stroke onset.

The authors say their findings underscore "the importance of speeding up the process for thrombolytic therapy in hospital and before admission to achieve shorter time from door to needle and from onset to treatment."

Reader Comments (1)

Dunn, Robert, MBBS, FACEM Physician, Emergency Medicine, Department of Emergency Medicine

The authors of this study have erroneously concluded that their study shows "..the effectiveness and safety of thrombolytic therapy in everyday clinical practice..". Efficacy of therapy cannot be proven by an observational study design, only an association.
In addition, there were signficant differences between the tPA treated and non treatment groups. Patients who did not receive tPA had more previous strokes, lower levels of baseline function (the primary outcome measure) and less likely to have received stroke centre care. Unfortunately we do not know the stroke severity of the 2 groups at onset as the non tPA group presented much later than those who were given tPA.
Despite all this patients who received tPA were 8.7% less likely to have an good functional outcome at 10 days and 4% more likely to die than those not treated. The authors report adjusted result suggesting the exact opposite, however it is hard to believe that any reasonable statistical adjustment could account for such a striking reversal in actual outcomes between the 2 groups.
Given the 4% higher mortality rate in the tPA treated group and the authors acknowledgement that "Thrombolytic therapy beyond the 4.5 hour time window seems to be associated with a significant increase in mortality in clinical practice", it is extremely concerning that the authors advocate that "..patients with a prolonged time from onset to treatment should be included in actual or future randomised controlled trials."
In short, the conclusions stated by the authors in relation to this study are not supported by the data they presented.

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