DAWN TRIAL
DAWN
• DWI or CTP Assessment with Clinical Mismatch in the Triage of
Wake-Up and Late Presenting Strokes Undergoing
Neurointervention with Trevo
• Published in NEJM on november 2017.
PARADIGM SHIFT
• Time based intervention to image based intervention
INTRODUCTION TO DAWN TRIAL
• Limited information on the effect of thrombectomy that is performed
more than 6 hours after the time that the patient was last known to
be well, particularly among patients with ischemic brain tissue that
has not yet undergone infarction and may be salvaged with
reperfusion.
• Patients with brain tissue that may be salvaged with reperfusion can
be identified by the presence of a clinical deficit that is
disproportionately severe relative to the volume of infarcted tissue on
imaging studies
AIMS AND OBJECTIVES
• Compared endovascular thrombectomy plus standard medical care
with standard medical care alone for the treatment of patients with
acute stroke who had last been known to be well 6 to 24 hours earlier
and who had mismatch between clinical deficit and infarct.
STUDY DESIGN
• DAWN trial was a multicenter, prospective, randomized, open-label
trial with a Bayesian adaptive enrichment design and with blinded
assessment of end points
INCLUSION
CRITERIA
EXCLUSION
CRITERIA
Treatment
• Patients were randomly assigned, in a 1:1 ratio
Thrombectomy plus standard medical care
Standard medical care alone (the control group).
Randomization was performed with the use of a central, Web-based
procedure, with block minimization processes to balance the two
treatment groups .
• Stratified according to-
• Mismatch criteria (Group A, Group B, or Group C),
• Interval between the time that the patient was last known to be well
and (6 to 12 hours or >12 to 24 hours)
• Occlusion site (intracranial internal carotid artery, first segment of the
middle cerebral artery).
• Trial was conducted at 26 centers in the United States, Canada, Europe,
and Australia,
• At least 40 mechanical thrombectomy procedures had been performed
at each center annually.
• Standard medical care was provided in accordance with local guidelines.
• Thrombectomy was performed with the use of the Trevo device (Stryker
Neurovascular),a retrievable self-expanding stent that is used to remove
occlusive thrombi and restore blood flow.
CO PRIMARY END POINTS
• The mean score for disability on the utility-weighted modified Rankin
scale (which ranges from 0 [death] to 10 [no symptoms or disability])
• The rate of functional independence (a score of 0, 1, or 2 on the
modified Rankin scale, which ranges from 0 to 6, with higher scores
indicating more severe disability) at 90 days.
RESULTS
• A total of 206 patients were enrolled; 107 were assigned to the thrombectomy
group and 99 to the control group.
• The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in
the thrombectomy group as compared with 3.4 in the control group (adjusted
difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior
probability of superiority, >0.999)
• The rate of functional independence at 90 days was 49% in the thrombectomy group
as compared with 13% in the control group (adjusted difference, 33 percentage
points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999).
• The rate of symptomatic intracranial hemorrhage did not differ significantly
between the two groups (6% in the thrombectomy group and 3% in the control
group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).
CONCLUSIONS
• Among patients with acute stroke who had last been known to be
well 6 to 24 hours earlier and who had a mismatch between clinical
deficit and infarct, outcomes for disability at 90 days were better with
thrombectomy plus standard care than with standard care alone.
dawn trial for mechanical thrombectomy ppt
dawn trial for mechanical thrombectomy ppt

dawn trial for mechanical thrombectomy ppt

  • 1.
  • 3.
    DAWN • DWI orCTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo • Published in NEJM on november 2017.
  • 7.
    PARADIGM SHIFT • Timebased intervention to image based intervention
  • 8.
    INTRODUCTION TO DAWNTRIAL • Limited information on the effect of thrombectomy that is performed more than 6 hours after the time that the patient was last known to be well, particularly among patients with ischemic brain tissue that has not yet undergone infarction and may be salvaged with reperfusion. • Patients with brain tissue that may be salvaged with reperfusion can be identified by the presence of a clinical deficit that is disproportionately severe relative to the volume of infarcted tissue on imaging studies
  • 10.
    AIMS AND OBJECTIVES •Compared endovascular thrombectomy plus standard medical care with standard medical care alone for the treatment of patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had mismatch between clinical deficit and infarct.
  • 11.
    STUDY DESIGN • DAWNtrial was a multicenter, prospective, randomized, open-label trial with a Bayesian adaptive enrichment design and with blinded assessment of end points
  • 12.
  • 13.
  • 14.
    Treatment • Patients wererandomly assigned, in a 1:1 ratio Thrombectomy plus standard medical care Standard medical care alone (the control group). Randomization was performed with the use of a central, Web-based procedure, with block minimization processes to balance the two treatment groups .
  • 15.
    • Stratified accordingto- • Mismatch criteria (Group A, Group B, or Group C), • Interval between the time that the patient was last known to be well and (6 to 12 hours or >12 to 24 hours) • Occlusion site (intracranial internal carotid artery, first segment of the middle cerebral artery).
  • 16.
    • Trial wasconducted at 26 centers in the United States, Canada, Europe, and Australia, • At least 40 mechanical thrombectomy procedures had been performed at each center annually. • Standard medical care was provided in accordance with local guidelines. • Thrombectomy was performed with the use of the Trevo device (Stryker Neurovascular),a retrievable self-expanding stent that is used to remove occlusive thrombi and restore blood flow.
  • 17.
    CO PRIMARY ENDPOINTS • The mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) • The rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days.
  • 18.
    RESULTS • A totalof 206 patients were enrolled; 107 were assigned to the thrombectomy group and 99 to the control group. • The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999) • The rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999). • The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).
  • 19.
    CONCLUSIONS • Among patientswith acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were better with thrombectomy plus standard care than with standard care alone.