COMMENTARY

Stroke t-PA Window Expanded, Certain Exclusions Apply

Mark J. Alberts, MD

Disclosures

August 17, 2009

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Mark Alberts, MD: Hello. My name is Dr. Mark Alberts, Professor of Neurology and Director of the Stroke Program at Northwestern University in Chicago. Welcome to this Medscape video blog with a focus on stroke.

What I would like to update you on is a new scientific statement from the American Heart Association, which was published in Stroke August 2009.[1]

This statement now gives the use of IV t-PA [intravenous tissue plasminogen activator] in the 3 to 4 and a half-hour time window a level 1B recommendation. So, this is really strong support to use IV t-PA in this 3 to 4 and a half-hour time window, and this is largely based on the results of the ECASS-3 [EuropeanCooperative Acute Stroke Study] trial,[2] which was published in the New England Journal of Medicine last year.

Now, this 1B recommendation does come with some important caveats. Patients above the age of 80 are excluded. Patients with a history of stroke and diabetes combined are also excluded. In addition, patients taking any type of oral anticoagulants, no matter what their INR [International Normalized Ratio] is, are also excluded. The usual inclusion and exclusion criteria for t-PA are also in effect for the 3 to 4 and a half-hour time window, with the exceptions that I just noted above. Another important exception is that if the stroke was very severe with an NIH [National Institutes of Health] Stroke Scale score greater than 25, the patient is also excluded. At Northwestern University, what we have chosen to do is to also exclude patients getting subcutaneous injections of powerful anticoagulants such as enoxaparin, dalteparin, and things like that because we thought that if the oral anticoagulants were excluded even with a normal INR, then it would be reasonable to also exclude subcutaneous anticoagulation that we commonly use for DVT [deep vein thrombosis] prophylaxis, and this is really based on an abundance of caution.

Now, 2 other important caveats: number one, even though the time window may be expanded to 4 and a half hours, all of the studies have shown that time is brain, and the sooner we can treat patients the better off their outcomes will be and most likely the lower the risk will be of any bleeding complications. So, even with a 4 and a half-hour time window, we must constantly remember that the door-to-needle time for t-PA is really 1 hour, and these patients need to be treated as rapidly as possible.

Another point that has come up a lot is, what about those of you who work at a primary stroke center? Will you be dinged by the Joint Commission for giving t-PA outside of the 3-hour time window? At this point, it's really unclear what's going to happen because even though this is a scientific advisory statement that gives t-PA a level 1B approval, the FDA [US Food and Drug Administration] has not changed the label. What I would recommend that you do at this point is clearly document all of those patients you give t-PA to beyond the 3-hour time window in terms of meeting the inclusion and exclusion criteria, how they did, and what the complications were. I think if you fully document all of these cases, then the Joint Commission when they come to visit you will have no problem knowing that in fact you did the right thing. So, there you have it. We now have an expanded time window for the use of IV t-PA with a grade 1B recommendation based on a recent publication in the journal Stroke. Thank you very much for your attention.

References

  1. Del Zoppo GJ, Saver JL, Jauch EC, Adams HP Jr; American Heart Association Stroke Council. Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American Heart Association/American Stroke Association. Stroke. 2009;40:2945-2948. Abstract

  2. Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359:1393-1395. Abstract

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