Abstract
Purpose: Current literature has limited information on the natural history of the stroke cohort eligible for mechanical thrombectomy. The placebo group from the PROACT II study is often used as a historical control, despite differences in entry criteria. Reported herein are data in a stroke cohort eligible for mechanical thrombectomy but untreated due to unavailability or inability to initiate endovascular treatment within the 8-hr window due to delayed presentation. The goal is to compare the functional independence rate with the PROACT placebo group.
Methods: The FIRST Trial is a prospective, multicenter, natural history study of a stroke cohort eligible for but untreated by mechanical thrombectomy presenting within 8 hrs of symptom onset from a large vessel occlusion and a NIHSS of at least 10. The primary endpoint is functional outcome at 90 days as defined by a mRS 0-2. Results are reported from an interim analysis.
Results: Fifty-nine (59) patients were enrolled and met study criteria for this interim analysis. The mean age was 68.2 ± 17 years; median NIHSS was 18 (5-34). Target vessel occlusions were in the ICA (35.7%), MCA (60.7%), and other (3.6%). At admission, the TIMI 0-1 rate was 89% (49/55), and the TICI 0-1 rate was 89% (48/54). Of these, only 10% (3/30) showed spontaneous recanalization (TIMI 2-3 or TICI 2a-3). Eleven of 55 (20%) patients achieved a good 90-day outcome, and 24 of 59 (40.7%) died. The serious adverse event rate was 52.6% (30/57), including respiratory failure (8 cases) and pneumonia (4 cases). A total of 6 (10%) patients suffered intracerebral hemorrhage (ICH). Below is a comparison of the MCA cohort vs. PROACT II placebo patients.
Conclusion: Compared with PROACT II placebo patients, the stroke cohort eligible for mechanical thrombectomy who were untreated have a lower rate of recanalization and worse outcome. These results indicate it may not be appropriate to use the PROACT placebo patients as historical controls for mechanical thrombectomy trials.
Methods: The FIRST Trial is a prospective, multicenter, natural history study of a stroke cohort eligible for but untreated by mechanical thrombectomy presenting within 8 hrs of symptom onset from a large vessel occlusion and a NIHSS of at least 10. The primary endpoint is functional outcome at 90 days as defined by a mRS 0-2. Results are reported from an interim analysis.
Results: Fifty-nine (59) patients were enrolled and met study criteria for this interim analysis. The mean age was 68.2 ± 17 years; median NIHSS was 18 (5-34). Target vessel occlusions were in the ICA (35.7%), MCA (60.7%), and other (3.6%). At admission, the TIMI 0-1 rate was 89% (49/55), and the TICI 0-1 rate was 89% (48/54). Of these, only 10% (3/30) showed spontaneous recanalization (TIMI 2-3 or TICI 2a-3). Eleven of 55 (20%) patients achieved a good 90-day outcome, and 24 of 59 (40.7%) died. The serious adverse event rate was 52.6% (30/57), including respiratory failure (8 cases) and pneumonia (4 cases). A total of 6 (10%) patients suffered intracerebral hemorrhage (ICH). Below is a comparison of the MCA cohort vs. PROACT II placebo patients.
Conclusion: Compared with PROACT II placebo patients, the stroke cohort eligible for mechanical thrombectomy who were untreated have a lower rate of recanalization and worse outcome. These results indicate it may not be appropriate to use the PROACT placebo patients as historical controls for mechanical thrombectomy trials.
Original language | English |
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Article number | 194 |
Journal | Stroke |
Volume | 44 |
Issue number | Suppl 1 |
DOIs | |
Publication status | Published - 7 Apr 2013 |
Event | International Stroke Conference 2013 - Hawai, United States Duration: 6 Feb 2013 → 8 Feb 2013 |