MR CLEAN

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incomplete Journal Club Article
. "Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands". The New England Journal of Medicine. 2015. 372(1):11-20.
PubMed

Clinical Question

Does endovascular intervention improve functional outcomes in patients with acute ischemic stroke secondary to large vessel occlusion in the anterior circulation?

Conclusion

Intraarterial treatment in select patients with AIS 2/2 proximal large vessel occlusion provides improved functional outcomes at 90 days.

Major Points

  • 3 prior trials published in 2013 (IMS III, Synthesis EXP, MR RESCUE) showed no benefit of mechanical thrombectomy over tPA alone in AIS
  • Improved functional outcomes at 90 days using MT +/- tPA in select patients with acute ischemic stroke
  • No difference in mortality
  • Proved safety with similar rates of symptomatic ICH
  • Completion of this trial lead to interim analysis of similar trials and consequent closure (ESCAPE, EXTEND-1A, SWIFT PRIME, REVASCAT)

Study Design

  • Prospective, Randomized multicenter trial
  • tPA vs tPA + IAT in patients with AIS within 6 hours with LVO
  • 16 hospitals in the Netherlands
  • N=500
  • 267 control cohort
  • 233 interventional cohort

Population

  • adults in the Netherlands
  • Median age 65
  • Median NIHSS 17 in interventional cohort, 18 in control

Patient Demographics

  • Adults with acute ischemic stroke presenting under 6 hours in the Netherlands

Inclusion Criteria

  • 18 years or older
  • Acute ischemic stroke presenting within 6 hours of onset
  • NIHSS 2+
  • confirmed large vessel occlusion - ICA, M1 or M2

Exclusion Criteria

  • Infarction in territory of occluded artery in past 6 weeks
  • Plts <40k, INR >3, aPTT > 50

Interventions

  • Intraarterial treatment
  • Arterial catheterization with IA thrombolysis or mechanical thrombectomy or both

Outcomes

  • Improved functional outcomes at 90 days in interventional group
  • no significant difference in mortality
  • no significant difference in occurrence of symptomatic intracranial hemorrhage

Primary Outcome

  • Independent functional outcome at 90 days measured by modified Rankin Score system
  • Absolute difference of 13.5 % between rates of functional independence (mRS 0-2)
  • mRS (0-2) 32.6% intervention group
  • mRS (0-2) 19.1% in control

Secondary Outcomes

  • NIHSS at 24 hours, 5-7 days or at discharge
  • Arterial recanalization at 24 hours by CTA/MRA
  • Infarct size by CT at 5-7 days


Subgroup analysis

Criticisms & Further Discussion

External Links

See Also

Funding

References

Authors:

Eric Lee