Table 1.
Selected Endovascular Therapy Trials for Acute Strokes.
| Clinical Trial | Citation | Study Design | Treatment window for Intervention | Number of Patients (n) | Rates of Symptomatic ICH (Treatment versus Control) |
Outcome |
|---|---|---|---|---|---|---|
| EXTEND | Ma et al. NEJM 2019 [27] |
Multicenter, randomized, placebo-controlled trial | 4.5 - 9.0 hours | 225 out of 310 planned Trial terminated because of a loss of equipoise; positive result from WAKE-UP trial |
6.2% vs 0.9% | Primary outcome of excellent functional outcome at 90 days was not met. However, there was a higher percentage of patients with no or minor neurologic deficits than the use of placebo |
| WAKE UP | Barow et al. JAMA Neurol. 2019 [28] |
Multicenter, double-blind, placebo-controlled randomized clinical trial | Unknown time of symptom onset | 503 |
2.0% vs. 0.4% |
Those treated with IV tPA had a favorable outcome at 90 days. No statistically significant difference in regard to symptomatic hemorrhage. |
| MR.WITNESS | Schwamm et al. Ann Neurol 2018 [7] |
Open-label, multicenter, phase 2a study | Unwitnessed onset at 4.5 to 24 hours from last known well | 80 | 1.3% vs. 0% | Primary outcome of safety (symptomatic hemorrhage and edema) was met. |
| ECASS-4 | Amiri et al. Int J of Stroke 2016 [8] |
Multicenter, double-blind, placebo-controlled randomized clinical trial | 4.5 and 9 hours | 119 out of 264 planned Trial terminated because of slow recruitment |
1.6%vs. 0% |
No significant difference in the modified Rankin scale at day 90. No mortality difference |
| ECASS-III | Hacke et al. NEJM 2008 [29] |
Multicenter, randomized double-blind trial |
3-4.5 hours | 821 | 2.4% vs. 0.2% | 7.2 % absolute difference in regards to favorable outcome. No significant difference in mortality |
| EPITHET | Davis et al. Lancet Neurol. 2008 [30] |
Multicenter, phase II double-blind, placebo-controlled randomized trial | 3-6 hours | 101 |
7.7% vs. 0% |
Primary outcome, which was a disease oriented imaging outcome of lower infarct growth was not met. However, IV tPA had a significant increase in reperfusion. No statistical differences in mortality or good functional outcome. |
| ECASS-II | Hacke et al. Lancet 1998 [4] |
Multicenter, randomized double-blind trial |
Less than 6 hours | 800 | 8.8% vs. 3.4% | No significant difference in regard to favorable outcome detected at 90 days |
| NINDS- II | NINDS Study Group NEJM 1995 [3] |
Multicenter, randomized double-blind placebo trial |
Less than 3 hours | 333 | 6.4%vs. 0.6% | 12% absolute increase in patients with little to no disability. Patients treated with IV tPA had significant improvement of mRS at 90 days. No mortality difference |
| NINDS-I | NINDS Study Group NEJM 1995 [3] |
Multicenter, randomized double-blind placebo trial |
Less than 3 hours | 291 | None | No statistically significant difference in improvement of NIHSS at 24 hours |