Randomized Controlled Trial to Optimize Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke - SELECT2

Mar 14, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Stryker Neurovascular
Date Published:
02/09/2024
Date Updated:
03/14/2024
Original Posted Date:
02/13/2023
References

Contribution To Literature:

Highlighted text has been updated as of March 14, 2024.

The SELECT2 trial showed that endovascular therapy resulted in better functional outcomes compared with medical therapy for acute ischemic stroke.

Description:

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

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with acute ischemic stroke were randomized to endovascular thrombectomy (n = 178) vs. medical therapy alone (n = 174). Endovascular therapy could be performed with stent retrievers, aspiration devices, or both.

  • Total number of enrollees: 352
  • Duration of follow-up: 90 days
  • Mean patient age: 66 years
  • Percentage female: 40%

Inclusion criteria:

  • 18-85 years of age
  • Acute ischemic stroke due to occlusion of the internal carotid artery or first segment of the middle cerebral artery
  • Symptom onset within 24 hours
  • Large ischemic core on noncontrast computed tomography (CT)

Exclusion criteria:

  • Intracranial hemorrhage
  • Multiple or ineligible thrombus location

Other salient features/characteristics:

  • Median time of symptom duration: 9.8 hours

Principal Findings:

The primary outcome, median score on the modified Rankin scale at 90 days, was 4 in the endovascular therapy group vs. 5 in the medical therapy group (p < 0.001). Higher score is correlated with greater disability.

Secondary outcomes:

  • Functional independence at 90 days: 20.3% in the endovascular therapy group vs. 7.0% in the medical therapy group
  • Death within 90 days: 38.4% in the endovascular therapy group vs. 41.5% in the medical therapy group
  • Complications with endovascular therapy: access site complication in 5 patients, cerebral-vessel dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11
  • Modified Rankin Scale score at 1 year: 5 in the endovascular therapy group vs. 6 in the medical therapy group (p = 0.0019)
  • All-cause mortality at 1 year: 45% in the endovascular therapy group vs. 52% in the medical therapy group

Endovascular thrombectomy across ischemic injury and penumbra profiles:

  • Ischemic injury was defined by noncontrast CT using ASPECTS score (a higher score represents no/minimal ischemic changes in the middle cerebral artery territory, while a lower score represents extensive ischemic changes) and CT perfusion/magnetic resonance imaging (MRI) ischemic core volumes.
  • Endovascular therapy improved functional outcomes vs. medical therapy within ASPECTS category 3 (adjusted generalized odds ratio [aGenOR], 1.71; 95% confidence interval [CI],1.04-2.81), 4 (aGenOR, 2.01; 95% CI, 1.19-3.40), and 5 (aGenOR, 1.85; 95% CI, 1.22-2.79).
  • Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for endovascular therapy vs. medical therapy was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) ≥100 mL, and 1.47 (95% CI, 0.84-2.56) ≥150 mL.

Interpretation:

Among patients with acute ischemic stroke, endovascular therapy was beneficial. Endovascular therapy with stent retrievers/aspiration devices improved functional outcomes among patients within 24 hours of acute ischemic stroke due to large vessel occlusion. Endovascular therapy improved functional independence at 90 days, which was sustained to 1 year; however, it was not associated with a reduction in mortality compared with medical therapy. Endovascular therapy was associated with decreased benefit as ischemic injury estimate increased. Access-site and cerebral-vessel complications occurred in the endovascular therapy group.

References:

Sarraj A, Hassan AE, Abraham MG, et al. Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles. JAMA 2024;331:750-63.

Editorial Comment: Pensato U, Lun R, Demchuk A. Thrombectomy in Medium to Large Ischemic Core: Do Patients Still Need to Be SELECTed? JAMA 2024;331:736-8.

Sarraj A, Abraham MG, Hassan AE, et al., on behalf of the SELECT2 Investigators. Endovascular thrombectomy plus medical care versus medical care alone for large ischemic stroke: 1-year outcomes of the SELECT2 trial. Lancet 2024;403:731-40.

Editorial Comment: Consoli A, Gory B. Long-term results of mechanical thrombectomy for large ischemic stroke. Lancet 2024;403:700-1.

Sarraj A, Hassan AE, Abraham MG, et al., on behalf of the SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med 2023;388:1259-71.

Editorial: Fayad P. Improved Prospects for Thrombectomy in Large Ischemic Stroke. N Engl J Med 2023;388:1326-8.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Endovascular Procedures, Ischemic Stroke, Thrombectomy


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