Preliminary results from the FIRST trial: Natural history of acute stroke from large vessel occlusion

Vallabh Janardhan, Ryan M. Gianatasio, Sherman H. Chen, Parita Bhuva, Mark M. Murray, Patricia Santos, Anita Guthmann, Madhu B. Vijayappa, Paul A. Hansen, Vivek Misra, Raymond Cheung, Thomas Leung, Iris Grunwald, Heather Hernandez, Leticia Barraza, Hope Buell, Sophia Kuo, Arani Bose, Siu Po Sit,

    Research output: Contribution to journalArticlepeer-review


    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.
    Original languageEnglish
    Article number194
    Issue numberSuppl 1
    Publication statusPublished - 7 Apr 2013
    EventInternational Stroke Conference 2013 - Hawai, United States
    Duration: 6 Feb 20138 Feb 2013


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