Use of TPA for Ischemic Stroke Remains Controversial
Many physicians think, 'If I give TPA and the patient has a hemorrhage, I'm going to be sued.'
By Damian McNamara
Elsevier Global Medical News
BOCA RATON, FLA. - An elevated risk of intracranial hemorrhage and a perceived higher risk of liability might explain some of emergency physicians' reluctance to administer tissue plasminogen activator to patients following ischemic stroke.
There is a fair amount of bias against the use of tissue plasminogen activator (TPA) in the emergency department, Dr. Joel Moll said at the annual meeting of the Florida College of Emergency Physicians.
In one survey, 40% of 1,105 ACEP members surveyed indicated they were unlikely to use TPA (Ann. Emerg. Med. 2005:46:56-60). About one-quarter of those respondents cited lack of clinical benefit, and about two-thirds were concerned about intracranial hemorrhage. "We worry about a post-TPA hemorrhage," Dr. Moll said, and he called that risk "the biggest con" regarding the use of TPA.
Estimates of intracranial hemorrhage (ICH) following TPA vary among studies, ranging from 3.3% of the 389 patients in the STARS (Standard Treatment With Alteplase to Reverse Stroke) trial (JAMA 2000;283:1145-50) to 15.7% among the 70 patients in a Cleveland Clinic study (JAMA 2000;283;1151-8). Dr. Moll questioned the validity of the Cleveland study findings, he said, because some centers had no experience, and 50% deviated from the guidelines.
"Follow the rules. I cannot emphasize that enough," said Dr. Moll, medical director of the emergency department, Shands at the University of Florida, Gainesville. He had no disclosure statement regarding TPA.
Noncompliance with national guidelines and a longer time to TPA administration are associated with a higher ICH risk, Dr. Moll said. Use of the agent beyond 3 hours from symptom onset is not supported in current protocols, he said. Large infarcts, hyperglycemia, hypertension, hyperthermia, and advanced age are other risk factors.
Dr. Moll encouraged emergency physicians to review the National Institutes of Health Stroke Scale (www.ninds.nih.gov/doctors/NIH_Stroke_Scale_Booklet.pdf). "We should all have familiarity with this. There is some objective value to determining what someone's deficit is. A 22 and higher is considered a serious stroke. I can't image what a 42 means," Dr. Moll said.
Dr. Moll also recommended familiarity with the stroke management protocol and TPA exclusions outlined in the randomized, double-blind, placebo-controlled National Institute of Neurological Disorders and Stroke (NINDS) rTPA stroke trial (N. Engl. J. Med. 1995;333:1581-7). That "landmark" study assessed 624 patients treated for stroke at 45 academic and community hospitals. "Despite the increased risk of intracranial hemorrhage, the NINDS study supported use of TPA, and [Food and Drug Administration] approval was based on this," he said.
In the study, the rate of asymptomatic ICH was similar between groups. Symptomatic ICH within 36 hours occurred for 6.4% of the rTPA group, compared with 0.6% of placebo patients. The 3-month functional outcomes were statistically significant in favor of rTPA in the NINDS trial. In addition, 3-month mortality rates did not differ significantly (17% for patients who received rTPA, compared with 21% in the placebo group).
It may seem counterintuitive, but doctors are more likely to lose lawsuits for failure to offer TPA to eligible patients and/or document consent versus adverse events, Dr. Moll said. "Many physicians think, 'If I give TPA and the patient has a hemorrhage, I'm going to be sued,' " he said.
However, 88% of settlements against a physician were associated with failure to offer TPA, according to a recent study (Ann. Emerg. Med. 2008;52;160-4). Emergency physicians were the most common physician defendant in a study of 33 TPA ischemic stroke therapy cases.
To reduce risk, notify emergency medical services if you are unable to provide thrombolytic therapy at your hospital, he said. In addition, document the time when symptoms were first observed; know the FDA inclusion and exclusion criteria for TPA; and do not administer anticoagulants within the first 24 hours of TPA. Also, discuss the risks and benefits of TPA with patients and their families. "Offer the drug. And if you don't, document why," he cautioned.
In some circumstances, you don't have the opportunity to get written consent, Dr. Moll said. If verbal consent is obtained instead, "document that you obtained verbal consent," he added. "But if you can get it in writing, it's a greater protection for you."