Presumed stroke: in-ambulance nitroglycerin patch fails RIGHT-2 trial

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Takeaway

  • Ambulance-based initiation of transdermal nitroglycerin (GTN; Nitro-Dur Patch, others) in patients with presumed stroke does not improve functional outcome, according to data from the RIGHT-2 trial.

Why this matters

  • High blood pressure is risk factor for poor outcomes in acute stroke, but optimal management is unclear.

Key results

  • Median time to randomization: 71 minutes.
  • Final diagnoses:
    • Ischemic stroke: 52%.
    • Intracerebral hemorrhage: 13%.
    • Transient ischemic attack: 9%.
    • Nonstroke mimic: 26%.
  • No difference in 90-day modified Rankin Scale score GTN vs sham:
    • Among patients with stroke, transient ischemic attack (3 vs 3; adjusted common OR for poor outcome, 1.25; P=.083).
    • Among all patients (3 vs 3; adjusted common OR for poor outcome, 1.04; P=.69).
  • Groups also similar on:
    • deaths (19% vs 17%; P=.47),
    • probable treatment-related deaths (6.3% vs 4.0%; P=.19), and
    • serious adverse events (33% vs 29%; P=.16).

Expert comment

  • In a comment, Karen C. Johnston, MD, and Valerie L. Durkalski-Mauldin, PhD, contend, "RIGHT-2 has provided high-level evidence that GTN given within 4 h of onset does not significantly improve outcome in hyperacute patients presenting with possible stroke. Additionally, the trial has added to the existing data that show that future hyperacute treatment trials can successfully offer study treatment in the prehospital setting."

Study design

  • UK multicenter, phase 3 randomized controlled trial: 1149 adults with presumed stroke
  • Randomization: transdermal GTN (5 mg once daily, 4 days) vs sham dressing started in ambulances by paramedics.
  • Main outcome: 90-day modified Rankin Scale score.
  • Funding: British Heart Foundation.

Limitations

  • Single-blind design.
  • Many patients did not get full duration of GTN.
  • Broad inclusion criteria.