Table 1.
Negative randomized trials comparing endovascular intervention (±thrombolysis) vs. intravenous thrombolysis alone
| IMS III | MR rescue | Synthesis | |
|---|---|---|---|
| Baseline | |||
| Total number of patients enrolled | 656 | 118 | 362 |
| Mean number of enrolled patients per centre per year | 2.0 | 0.8 | 3.6 |
| Median age | 69 | 65 | 66 |
| Minimal baseline NIHSS allowed | 8 | 6 | 2 |
| Median NIHSS at baseline | 17 | 17 | 13 |
| Confirmation of major artery occlusion by CT-/MR-angiography | No | Yes | No |
| Penumbra imaging used for patient selection | No | Partly | No |
| i.v. thrombolysis use in the intervention arm | 100% | 37% | 0% |
| Time delays | |||
| Time delay as entry criterion | tPA given within <3 h | Enrolment within <8 h | Enrolment within <4.5 h |
| Stroke onset—tPA start time | 122 min | 165 min | |
| Stroke onset—reperfusion time in the group with intervention | 5.4 h | 7 h | 3.8 h |
| Treatment | |||
| Periprocedural anticoagulants/antiplatelets | Heparin 2000 U i.v., followed by 450 U/h during intervention | Heparin 5000 U i.v., followed by 500 U/h during intervention | |
| Stent-retrievers use (intervention group) | 1% | 0% | 12.7% |
| Procedural complications | 26.5% | ||
| Outcomes | |||
| Reperfusion (TICI Grade 2b or 3) | 43% | 44% | |
| Favourable neurologic outcome (mRs 0–2 at 90 days) in the intervention group | 41% | 19% | 42% |
| Favourable neurologic outcome (mRs 0–2 at 90 days) in the i.v. thrombolysis group | 39% | 20% | 46% |
| Symptomatic intracerebral haemorrhage (intervention group) | 6.2% | 4.7% | 5.5% |
| Subarachnoid haemorrhage | 11.5% | ||
| Asymptomatic intracerebral haemorrhage (intervention group) | 27.4% | 65.6% | |
| Early mortality (7 days) in the intervention group | 12% | 8% | |
| Late mortality (90 days) in the intervention group | 19.1% | 19% | 14.4% |