After European Cooperative Acute Stroke Study 3: Mission Accomplished?

Marc Fisher MD Kennedy Lees MD Section Editors: The results of the third European Cooperative Acute Stroke Study (ECASS 3) show that patients with acute stroke, who could not make it to the hospital within the 3-hour treatment time window, still have a chance to benefit from intravenous alteplase if they can be treated within 4.5 hours of stroke onset.1 They will not be exposed to an increased risk of brain hemorrhage compared with patients being treated earlier. The European Medicines Agency required this trial with its relatively close treatment time window, because authorities were afraid of an increased risk for patients treated after 3 hours. After approval to treat patients with stroke with alteplase until 4.5 hours after symptom onset, more patients being remote from stroke centers and brain imaging facilities will get a chance to be treated. However, “having more time does not mean we should be allowed to take more time” as the authors pointed out.1 The door-to-needle time should be kept short giving the patients the best chances for recovery. What is the probability that a patient with acute stroke will recover due to treatment with alteplase? In ECASS 3, 221 of 403 placebo-treated patients (55%; 95% CI, 50% to 60%) were disabled or dead (modified Rankin Scale [mRS]: 2 to 6) at 3 months after stroke and 199 of 418 alteplase-treated patients (48%; 95% CI, 43% to 52%; intent-to-treat analysis). This means that 7% of patients had a treatment benefit, but 93% of the patients had none corresponding to a number needed to treat of 14. To show an effect beyond chance in 29 patients, 821 patients had to be exposed to placebo or alteplase. The modest effect size is similar to that of other randomized, …