Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke - DEFUSE 3

Jul 16, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health, National Institute of Neurological Disorders and Stroke.
Date Published:
07/10/2019
Date Updated:
07/16/2019
Original Posted Date:
01/25/2018
References

Contribution To Literature:

The DEFUSE 3 trial showed that endovascular thrombectomy was superior to standard medical therapy at improving functional outcomes. 

Description:

The goal of the trial was to evaluate endovascular thrombectomy compared with standard medical therapy alone among patients with acute ischemic stroke within 6 to 16 hours of symptom onset.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with acute ischemic stroke were randomized to endovascular thrombectomy (n = 92) versus standard medical therapy alone (n = 90). Endovascular thrombectomy could be performed with any approved thrombectomy device. General anesthesia was discouraged. Tissue plasminogen activator (t-PA) was not allowed if considered >4.5 hours after symptom onset.

  • Total number of enrollees: 182
  • Duration of follow-up: 90 days; trial terminated early due to efficacy
  • Mean patient age: 70 years
  • Percentage female: 50%

Inclusion criteria:

  • Occlusion of internal carotid artery (cervical or intracranial) or proximal middle cerebral artery
  • Infarct volume (ischemic core) <70 cc
  • Ratio of volume of ischemic tissue to initial infarct volume ≥1.8
  • Absolute volume of potentially reversible ischemia (penumbra) ≥15 cc

Exclusion criteria:

  • Limited life expectancy
  • Pregnancy
  • Unable to undergo brain imaging
  • Bleeding abnormality
  • Seizures at onset
  • Glucose <50 mg/dl or >400 mg/dl
  • Platelet count <50,000/cc

Other salient features/characteristics:

  • Treatment with t-PA: 10%
  • Median time from stroke onset to imaging: approximately 10 hours

Principal Findings:

The primary outcome, median score on the modified Rankin scale at 90 days, was 3 in the endovascular thrombectomy group compared with 4 in the standard medical therapy alone group. This translates into a favorable shift in the distribution of functional outcomes with endovascular thrombectomy (odds ratio 2.77; p < 0.001).

Secondary outcomes:

  • Functional independence: 45% for endovascular thrombectomy vs. 17% for standard medical therapy (p < 0.001)
  • Mortality at 90 days: 14% for endovascular thrombectomy vs. 26% for standard medical therapy (p = 0.05)
  • Intracranial hemorrhage: 7% for endovascular thrombectomy vs. 4% for standard medical therapy (p = 0.75)
  • Median length of hospital stay: 6.5 days for endovascular thrombectomy vs. 9.1 days for standard medical therapy (p < 0.001)
  • Median home-time: 55 days for endovascular thrombectomy vs. 0 days for standard medical therapy (p < 0.001)
  • Endovascular therapy vs. medical therapy was associated with more favorable living situations at discharge, 30 days, and 90 days

Interpretation:

Among patients with acute ischemic stroke with symptom onset within 6 to 16 hours, endovascular therapy was superior to standard medical therapy alone. Endovascular therapy was associated with an improvement in functional outcomes, including functional independence, and survival. Endovascular therapy was also associated with reduced hospital stay, more home-time, and more desirable living situations. Due to relatively late presentation after symptom onset, patients were ineligible for thrombolytic therapy. The incidence of intracranial hemorrhage was similar between treatment groups. An important inclusion criterion of this trial was documentation of a penumbral region that represented potentially salvageable tissue. Future trials will need to test an even longer window of endovascular therapy.

References:

Tate WJ, Polding LC, Kemp S, et al. Thrombectomy results in reduced hospital stay, more home-time, and more favorable living situations in DEFUSE 3. Stroke 2019;Jul 10:[Epub ahead of print].

Albers GW, Marks MP, Kemp S, et al., on behalf of the DEFUSE 3 Investigators. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. N Engl J Med 2018;378:708-18.

Keywords: Coronary Occlusion, Carotid Artery, Internal, Diagnostic Imaging, Endovascular Procedures, Geriatrics, Intracranial Hemorrhages, Ischemia, Perfusion Imaging, Primary Prevention, Standard of Care, Stroke, Thrombectomy, Thrombolytic Therapy, Tissue Plasminogen Activator, Vascular Diseases


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