Explore This IssueACEP Now: Vol 34 – No 03 – March 2015
In 2013, ACEP updated its clinical policy for the use of intravenous tissue plasminogen activator (tPA) for the management of acute ischemic stroke in the emergency department.1 This statement, eight years in the making, was published jointly by ACEP and the American Academy of Neurology (AAN) and endorsed by the Emergency Nurses Association and the Neurocritical Care Society.
Now it’s toast.
The ensuing outcry following its publication, followed by an ACEP Council resolution to reconsider the content, has led to a wholesale revision. Most important, even more than the proposed changes to this policy, were the changes to the clinical policy process, with improved adherence to rating methodology, an open comment period to draft policies, and improved management of conflict-of-interest (COI) issues. The last issue, management of COI, was a substantial source of prior controversy, covered in part by an investigative piece about untrustworthy guidelines in The BMJ.2 The authorship of this new version of the tPA policy has changed, and any association with the AAN is conspicuously absent.
The changes enshrined in this draft are substantial. The 2013 version made two recommendations regarding the use of IV tPA in the emergency department. The first, a Level A recommendation reflecting a high degree of clinical certainty, recommended tPA be offered to ischemic stroke patients meeting National Institute of Neurological Disorders and Stroke (NINDS) criteria who are treatable within 3 hours. The second, a Level B recommendation reflecting moderate clinical certainty, recommended tPA be offered to patients meeting European Cooperative Acute Stroke Study (ECASS) III criteria who are treatable between 3 and 4.5 hours. A caveat provided for this second recommendation noted the US Food and Drug Administration license for tPA is limited to 3 hours, with the subsequent application for extension having been rejected.
The changes enshrined in this draft are substantial. The 2013 version made two recommendations regarding the use of IV tPA in the emergency department.
Many emergency physicians felt these recommendations placed them in a difficult position by endorsing a treatment with significant adverse effects. While stroke neurologists and the American Heart Association forged ahead, with substantial contributions from Genentech, a vocal cohort of emergency physicians continued to express reservations and call for more data. In March 2014, the Australasian College for Emergency Medicine outlined a position statement indicating tPA was a potentially beneficial treatment for stroke but such treatment could not be considered a standard of care in light of conflicting evidence.3 Then, in September 2014, the UK Medicines and Healthcare Products Regulatory Agency reopened a review of the “balance of benefits and risks” of the use of tPA for stroke.4 Now this new tPA policy draft shifts ACEP in the same direction.