Randomized Trial of Revascularization With Solitaire FR Device vs. Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset - REVASCAT

Mar 07, 2016
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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:
Fundació Ictus Malaltia Vascular
Date Presented:
02/19/2016
Date Published:
04/17/2015
Date Updated:
03/07/2016
Original Posted Date:
02/19/2016
References

Description:

The goal of the trial was to evaluate thrombectomy compared with medical therapy alone among patients with acute ischemic stroke.

Contribution to the Literature: The REVASCAT trial showed that thrombectomy during acute ischemic stroke resulted in less disability compared with intravenous thrombolytic therapy alone.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with acute ischemic stroke who received intravenous alteplase within 4.5 hours of symptom onset without recanalization were randomized to thrombectomy with the Solitaire stent retriever (n = 103) versus medical therapy alone (n = 103).

Inclusion criteria:

  • Patients 18-85 years of age with acute ischemic stroke due to proximal anterior artery occlusion
  • Total number of enrollees: 206
  • Duration of follow-up: 90 days and 1 year
  • Mean patient age: 66 years
  • Percentage female: 47%
  • Percentage diabetics: 21%

Exclusion criteria:

  • Large ischemic stroke

Other salient features/characteristics:

  • Median NIHSS score: 17
  • Treatment with intravenous alteplase: 68% in the thrombectomy group vs. 77% in the medical therapy group
  • Thrombectomy was performed during general anesthesia: 6.7%

Principal Findings:

  • Adjusted odds ratio for improvement of 1 point in the Rankin scale (odds ratio, 1.7 favoring thrombectomy; 95% confidence interval, 1.05-2.8)

Secondary outcomes:

  • Score of 0-2 on modified Rankin scale at 90 days: 43.7% with thrombectomy vs. 28.2% with medical therapy (p < 0.05)
  • Score of 0-2 on modified Rankin scale at 1 year: 43.7% with thrombectomy vs. 30.1% with medical therapy (p < 0.05)
  • Death at 90 days: 18.4% vs. 15.5% (p = not significant)
  • Death at 1 year: 23.3% vs. 24.3% (p = not significant)
  • Symptomatic intracranial hemorrhage: 1.9% vs. 1.9% (p = not significant)

Interpretation:

Among patients with acute ischemic stroke, stent retriever thrombectomy during conscious sedation was superior to intravenous thrombolytic therapy alone. Thrombectomy reduced the severity of post-stroke disability at 90 days and 1 year. Mortality and symptomatic intracranial hemorrhage were similar between the groups. Accumulating evidence is documenting the benefit of thrombectomy for treatment of acute ischemic stroke.

References:

Presented by Dr. Antoni Dávalos at the International Stroke Conference, February 19, 2016, Los Angeles, CA.

Jovin TG, Chamorro A, Cobo E, et al., on behalf of the REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med 2015;372:2296-2306.

Keywords: Anesthesia, General, Arteries, Conscious Sedation, Fibrinolytic Agents, Intracranial Hemorrhages, Myocardial Revascularization, Primary Prevention, Stents, Stroke, Thrombectomy, Thrombolytic Therapy, Tissue Plasminogen Activator


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