Thrombolysis in the 3- to 4.5-Hour Window
What Do ECASSkeptics Want?
Our patient has no contraindications for intravenous thrombolysis and meets the eligibility criteria specified in European Cooperative Acute Stroke Study (ECASS) III. Therefore, at first glance it seems that there is no basis for disagreement or controversy. He should be treated immediately with intravenous recombinant tissue-type plasminogen activator (rtPA) in line with the results of ECASS-III, a blinded, randomized, placebo-controlled trial, and professional guidelines including the American Heart Association/American Stroke Association (class I; Level of Evidence B recommendation). This position is strongly articulated by Drs Schellinger and Köhrmann.
Is it really true that the 4.5-hour window for intravenous rtPA is so firmly established? Dr Wechsler expresses some doubts, and he is not alone. The United States Food and Drug Administration, the largest agency regulating medical products on planet earth, denied an application to extend the time window for intravenous rtPA treatment to 4.5 hours. The details of the application and the reasons behind the Food and Drug Administration’s denial have not been released to the scientific community, leading to speculations that the evidence from ECASS-III and supporting data were not sufficient in the Food and Drug Administration’s opinion.
ECASS-III is a landmark study in …