Table 1.
Summary of major clinical trials of revascularization therapies.
| Trial name | Year published | Study type | Intra-arterial therapy | Adjunctive therapy | Recanalization (%) | mRS 0–2 (%) | sICH (%) | Mortality (%) | Comments |
|---|---|---|---|---|---|---|---|---|---|
| NINDS | 1995 | RCT | None | IV tPA | NR | 39 | 6.4 | 17 | Includes small vessel strokes and low NIHSS strokes |
| NINDS | 1995 | RCT | None | Placebo | NR | 28 | 0.6 | 21 | Includes small vessel strokes and low NIHSS strokes |
| PROACT I | 1998 | RCT | rpro-UK | IV heparin | 57.7 | 30.8 | 15.4 | 26.9 | Recanalization reported as TIMI 2 or more; |
| outcome reported as mRS 0–1 | |||||||||
| PROACT I | 1998 | RCT | none | IV heparin | 14.3 | 21.4 | 7.1 | 42.9 | Recanalization reported as TIMI 2 or more; |
| outcome reported as mRS 0–1 | |||||||||
| PROACT II | 1999 | RCT | rpro-UK | IV heparin | 66 | 40 | 10 | 25 | Recanalization reported as TIMI 2 or more |
| PROACT II | 1999 | RCT | none | IV heparin | 18 | 25 | 2 | 27 | Recanalization reported as TIMI 2 or more |
| IMS I | 2004 | Open label | tPA | IV tPA (low dose) | 56 | 43 | 6.3 | 16 | Recanalization reported as TIMI 2 or more |
| MERCI | 2005 | Single arm | Merci | None | 46 | 27.7 | 7.8 | 43.5 | Recanalization reported as TIMI 2 or more |
| IMS II | 2007 | Open label | tPA | IV tPA (low dose) | 60 | 46 | 9.9 | 16 | Recanalization reported as TIMI 2 or more |
| MULTI MERCI | 2008 | Single arm | Merci; +/− IA tPA | +/− IV tPA | 68 | 36 | 9.8 | 34 | Recanalization reported as TIMI 2 or more |
| Penumbra Pivotal | 2009 | Single arm | Penumbra | +/− IV tPA | 81.6 | 25 | 11.2 | 32.8 | Recanalization reported as TIMI 2 or more |
| SARIS | 2009 | Single arm | implanted stent | +/− IV tPA | 100 | 60 | 5 | 25 | Small series (n = 20) |
| SWIFT | 2012 | RCT | Solitaire | +/− IV tPA | 61 | 58 | 2 | 17 | Recanalization reported as TIMI 2 or more |
| SWIFT | 2012 | RCT | Merci | +/− IV tPA | 24 | 33 | 11 | 34 | Recanalization reported as TIMI 2 or more |
| Trevo 2 | 2012 | RCT | Trevo | +/− IV tPA | 86 | 40 | 7 | 33 | Recanalization reported as TICI 2a or more |
| Trevo 2 | 2012 | RCT | Merci | +/− IV tPA | 60 | 21.8 | 9 | 24 | Recanalization reported as TICI 2a or more |
| STAR | 2013 | Single arm | Solitaire | +/− IV tPA | 79.2 | 57 | 1.5 | 6.9 | |
| IMS III | 2013 | RCT | tPA and/or mechanical | IV tPA (variable dose) | 38–44 | 40.8 | 6.2 | 19.1 | Recanalization reported as TICI 2b or more |
| IMS III | 2013 | RCT | None | IV tPA | NR | 38.7 | 8.9 | 21.6 | |
| Synthesis | 2013 | RCT | tPA and/or mechanical | None | NR | 42 | 6 | 8 | |
| Synthesis | 2013 | RCT | None | IV tPA | NR | 46 | 6 | 6 | |
| MR Rescue | 2013 | RCT | IA tPA, Merci and/or Penumbra | +/− IV tPA | 67 | 18.8 | 4.7 | 18.8 | Recanalization reported as TICI 2a or more |
| MR Rescue | 2013 | RCT | None | +/− IV tPA | NR | 20.4 | 3.7 | 24.1 | |
| MR CLEAN | 2014 | RCT | Neurothrombectomy +/− IA tPA | +/− IV tPA | 81.6 | 32.6 | 7.7 | 18.9 | Recanalization reported as TICI 2a or more |
| MR CLEAN | 2014 | RCT | None | +/− IV tPA | NR | 19.1 | 6.4 | 18.4 | |
| ESCAPE | 2015 | RCT | Neurothrombectomy +/− IA tPA | +/− IV tPA | 72.4 | 53 | 3.6 | 10.4 | Recanalization reported as TICI 2b or more |
| ESCAPE | 2015 | RCT | None | +/− IV tPA | NR | 29.3 | 2.7 | 19 | |
| EXTEND IA | 2015 | RCT | Solitaire | IV tPA | 100 | 71 | 0 | 9 | Reperfusion assessed on CT imaging |
| EXTEND IA | 2015 | RCT | None | IV tPA | 37 | 40 | 6 | 20 | Reperfusion assessed on CT imaging |
| SWIFT PRIME | 2015 | RCT | Solitaire | IV tPA | 88 | 61.2 | 1 | 9.2 | Recanalization reported as TICI 2b or more |
| SWIFT PRIME | 2015 | RCT | None | IV tPA | NR | 35.5 | 3.1 | 12.4 |
The disparities between rates of recanalization and good clinical outcome are highlighted, emphasizing the need for adjunctive therapy such as infusion of 3K3A-APC. Modified after Jadhav and Jovin (2013) and other sources. NR, not reported; RCT, Randomized Clinical Trial. See text for details and accompanying list for other abbreviations.