REstart or STop Antithrombotics Randomised Trial - RESTART

May 30, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
British Heart Foundation
Date Published:
05/22/2019
Date Updated:
05/30/2019
Original Posted Date:
05/30/2019
References

Contribution To Literature:

The RESTART trial showed that resuming antiplatelet therapy at a median of 2.5 months after symptomatic intracerebral hemorrhage does not increase the risk of recurrent intracerebral bleeding compared with avoiding antiplatelet agents.

Description:

The goal of the trial was to assess the safety and efficacy of resuming antiplatelet therapy among patients with a spontaneous intracerebral hemorrhage who were taking antiplatelet or anticoagulant therapy at the time of the event.   

Study Design

Eligible patients were randomized in a 1:1 fashion to either resume antiplatelet therapy (n = 268) or avoid antiplatelet therapy (n = 269).

  • Total number of enrollees: 537
  • Duration of follow-up: 4 years
  • Mean patient age: 76.5 years
  • Percentage female: 33%

Inclusion criteria:

  • Adults ≥18 years
  • Survived ≥24 hours after spontaneous intracerebral hemorrhage, confirmed by brain imaging, and were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease at the onset of intracerebral hemorrhage, after which therapy was discontinued

Exclusion criteria:

  • Intracerebral hemorrhage attributable to preceding head injury, hemorrhagic transformation of an ischemic stroke, or intracranial hemorrhage without intracerebral hemorrhage
  • Still on antithrombotic therapy after intracerebral hemorrhage
  • Pregnant, breastfeeding

Other salient features/characteristics:

  • White race: 92%
  • Prior history of intra- or extracranial hemorrhage: 8.5%
  • Time since intracerebral hemorrhage symptom onset: 76 days

Principal Findings:

The primary outcome, recurrent symptomatic spontaneous intracerebral hemorrhage for resuming vs. avoiding antiplatelet medications, was 4% vs. 9% (p = 0.057).

Secondary outcomes, for resuming vs. avoiding antiplatelet medications:

  • All major hemorrhage events: 18 vs. 25 (p = 0.27)
  • Ischemic stroke: 7% vs. 10%
  • Major occlusive vascular events: 45 vs. 52 (p = 0.39)

Interpretation:

The results of this trial indicate that resuming antiplatelet therapy at a median of 2.5 months after symptomatic intracerebral hemorrhage does not increase the risk of recurrent intracerebral bleeding compared with avoiding antiplatelet agents. In fact, there was a clear trend towards lower bleeding with resuming antiplatelet agents. Although this seems counterintuitive, it may be related to the close relationship between arterial thrombosis and bleeding. These are important findings.


References:

RESTART Collaboration. Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial. Lancet 2019;May 22:[Epub ahead of print].

Editorial Comment: Ziai WC, Tsiskaridze A. Restarting antiplatelet therapy after intracerebral haemorrhage. Lancet 2019;May 22:[Epub ahead of print].

Clinical Topics: Anticoagulation Management, Geriatric Cardiology, Prevention

Keywords: Anticoagulants, Bleeding Time, Brain Ischemia, Cerebral Hemorrhage, Geriatrics, Neuroimaging, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, Thrombosis, Vascular Diseases


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