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  • MR CLEAN Original

    • MR CLEAN



    Contents



    1. Clinical Question
    2. Bottom Line
    3. Major Points
    4. Guidelines
    5. Design
    6. Population
    7. Interventions
    8. Outcomes
    9. Criticisms
    10. Funding
    11. Further Reading

    Clinical Question


    In patients with acute ischemic stroke due to a proximal intracranial arterial occlusion of the anterior circulation, is intraarterial treatment administered within 6 hours after stroke onset effective and safe?

    Bottom Line


    In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment within 6 hours after stroke onset improved functional outcomes without increasing mortality, compared to usual care alone.

    Major Points




    Guidelines


    Current guidelines for the treatment of acute ischemic stroke recognize the role of intraarterial treatment, such as mechanical thrombectomy, as a method to improve outcomes in patients with proximal arterial occlusions.

    Design


    - Pragmatic, phase 3, multicenter, randomized, open-label treatment, blinded end-point evaluation
    - N=500 patients
    - Intraarterial treatment + usual care vs. usual care alone
    - Setting: 16 centers in the Netherlands
    - Enrollment: December 2010 to March 2014
    - Follow-up: 90 days
    - Analysis: Intention-to-treat
    - Primary outcome: Modified Rankin scale score at 90 days

    Population


    - Inclusion Criteria: Patients aged ≥18 years with acute ischemic stroke caused by intracranial occlusions confirmed via imaging; treatment possible within 6 hours of symptom onset; NIHSS score ≥2
    - Exclusion Criteria: Detailed criteria provided in the study protocol
    - Baseline Characteristics: Mean age 65 years, balanced risk factors and prerandomization treatments

    Interventions


    - Assigned patients to intraarterial treatment involving catheterization, thrombolysis, mechanical thrombectomy, or combination, along with usual care including intravenous alteplase
    - Intraarterial treatment could occur within 6 hours post-stroke onset

    Outcomes


    - Primary outcome: Adjusted common odds ratio for a shift indicating better outcomes on the modified Rankin scale was 1.67 (favoring intraarterial treatment)
    - Secondary outcomes: Improved NIHSS score, increased recanalization rate, reduced final infarct volume
    - Safety: No significant difference in mortality, procedure-related complications, or serious adverse events during follow-up

    Criticisms


    - Randomization resulted in more patients in the control group
    - Relatively low reperfusion rate (58.7%) compared to more recent case series
    - Complicated procedures such as acute cervical carotid stenting occurred in some patients
    - Possible bias due to non-blinded patients knowing their treatment assignment

    Funding


    - Funded by the Dutch Heart Foundation and unrestricted grants from AngioCare Covidien/ev3, Medac/Lamepro, and Penumbra

    Further Reading


    - Full text article available with additional details, including supplementary material and appendices, published in The New England Journal of Medicine.