| Alteplase Trials and Data | |
|---|---|
| Twenty-Year History of the Evolution of Stroke Thrombolysis with Intravenous Alteplase to Reduce Long-Term Disability _____ An article reviewing the history and designs of trials evaluating use of alteplase in acute ischemic stroke, its indications and contraindications, and the importance of tPA in practice | LINK |
| (NINDS) Tissue Plasminogen Activator for Acute Ischemic Stroke _____ Two part RCT comparing tPA to placebo for patients with acute ischemic stroke within 3 hours. In part 1, no significant difference between tPA and placebo was seen for early neurologic improvement (NIHSS improved by 4, or resolution of deficits at 24 hours), though improvement in NIHSS scores were generally more favorable in tPA groups in post-hoc analyses. In part 2, tPA was associated with increased odds of favorable 90-day functional outcome. Despite increased incidence of ICH, mortality was not significantly higher with tPA. | LINK |
| (ECASS 3) Thrombolysis with Alteplase 3 to 4.5 Hours after Acute Ischemic Stroke _____ RCT comparing alteplase to placebo in patients aged 18-80 with acute ischemic stroke within the 3-4.5 hour window, finding increased odds of favorable 90-day functional outcome in the alteplase group. Despite increased incidence of ICH in the alteplase group, mortality did not differ between groups. | LINK |
| (EPITHET) Effects of alteplase beyond 3 h after stroke in the Echoplanar Imaging Thrombolytic Evaluation Trial _____ RCT comparing alteplase to placebo in patients with acute ischemic stroke in the 3-6 hour time window who have a mismatch in perfusion-weight MRI and DWI. There was no significant reduction of mean infarct growth on MR imaging with alteplase use, though it was associated with greater reperfusion with reduced infarct growth and improved neurologic outcome in this population. | LINK |
| (IST-3) The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6h of acute ischaemic stroke _____ RCT comparing alteplase and placebo in patients with acute ischemic stroke within the 6 hour time window, finding no significant improvement in patients were are alive and independent at 6 months with alteplase, though there was a significant shift in ordinal analysis of OHS scores. There was an increase in hemorrhage and early death with alteplase use, but similar rates of death at 6 months. | LINK |
| On Critiques of NINDS | |
|---|---|
| Myths Regarding the NINDS rt-PA Stroke Trial: Setting the Record Straight _____ An article outlining and addressing commonly encountered questions and issues regarding the interpretation of the NINDS tPA trials results and conclusions | LINK |
| A Graphic Reanalysis of the NINDS Trial _____ A reanalysis using individual patient-level outcomes data from the NINDS trial to create graphical representations of outcomes, purporting to show little difference in outcomes between patients who received tPA vs placebo | LINK |
| Graphic Reanalysis of the Two NINDS-tPA Trials Confirms Substantial Treatment Benefit _____ A publication of graphical representations of outcomes data from the NINDS trial dataset, demonstrating significantly greater improvement among patients who received tPA in the trial than those who did not, directly addressing some of the statements from the above graphic reanalysis paper. | LINK |