Will More Stroke Patients Receive Thrombolytics Now?

According to this article in the September 25th edition of the New England Journal of Medicine, alteplase improves the outcomes in stroke patients up to 4.5 hours after symptom onset. Previously, the “window” of effectiveness was only three hours. The clinical trial criteria are here.

The percentage of patients having a favorable outcome at 90 days in this study wasn’t huge, but was statistically significant - 52% of patients receiving alteplase had good outcomes compared with 45% of patients who received placebo. At the same time 27% of patients had some type of bleeding after receiving thrombolytics compared with only 17% of patients who had bleeding after receiving placebo. The rate ofsymptomatic bleeding in the brain was 2.4% for thrombolytics versus 0.2% for placebo.

So while you may have an overall improvement in your outcome at 90 days if you get the medication, more than 1 in 4 patients who receive the medication will have bleeding and 1 in 40 patients will have symptomatic bleeding.

Is it worth the risk?

In the editorial article accompanying the study, one of the study authors states that “one cannot help wondering why thrombolytic therapy has traveled such a long, difficult path to wider clinical use.”

I can help wondering.

Thrombolytics are one of the few things that physicians can give that will have an immediate and significant harm on patients. Sure, patients may occasionally have bad outcomes from allergic events or they may have undesirable side effects from some medications. But 2.4% of patients will havesymptomatic bleeding in their brains when they get thrombolytics. Some of those patients will die. Bad outcomes in this society are a plaintiff attorney’s dream.

No health care provider wants to risk their life savings even if there is a “small” chance that they could be sued.

So the choice is …
1. Let patient continue with the stroke symptoms they have already presented with and follow the doctrine of “primum non nocere.” After all, even this study shows that if doctors do nothing, 45% of the patients will get better on their own.
-or-
2. Give a medication that may improve clinical outcome in 7% more of the patients … at the risk of getting dragged through 3-5 years of litigation and losing your life savings if the patient has a bad outcome from the medication.

What would you choose?

Want a simple way to immediately expand the use of thrombolytic therapy?

Grant blanket immunity from liability if thrombolytics are given according to the established guidelines. Create a checklist at “guidelines.gov” and let all healthcare providers download it. If the guidelines are followed, the healthcare providers can’t be sued or have any professional actions taken against them. Period.

If an emergency physician gets a CT report from a radiologist that says “no bleed,” the patient meets the criteria for thrombolytic therapy and doesn’t have any exclusion criteria, then the emergency personnel cannot be held liable for any bad outcomes for giving thrombolytics.

There will still be some docs that philosophically disagree with giving patients a medication that could kill them. Nevertheless, there would be an instant spike in thrombolytic use. I guarantee it.

Plaintiff attorneys will stomp up and down at the thought of this idea.

Then again, 7% more of the stroke victims in this country - some of them attorneys - might be able to stomp up and down if docs weren’t so afraid to give thrombolytics for strokes.

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