Ticagrelor alone vs ticagrelor plus aspirin in high-risk patients after PCI

  • Mehran R & al.
  • N Engl J Med
  • 26 Sep 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • Ticagrelor monotherapy was associated with a lower incidence of bleeding than ticagrelor plus aspirin, without leading to ischaemic harm over a period of 1 year among high-risk patients who underwent percutaneous coronary intervention (PCI) and completed 3 months of dual antiplatelet therapy.

Why this matters

  • Findings suggest ticagrelor monotherapy may be a suitable strategy to lower bleeding risk and preserving the ischaemic benefit in patients who have undergone PCI.

Study design

  • In the TWILIGHT trial, patients who had not had a major bleeding event or an ischaemic event (n=7119) at 3 months post-hospital discharge were randomly assigned to receive either aspirin (n=3564) or placebo (n=3555) along with the continuation of ticagrelor for 12 months.
  • Primary outcome: first occurrence of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding.
  • Secondary outcome: death from any cause, non-fatal myocardial infarction (MI) or non-fatal stroke.
  • Funding: AstraZeneca.

Key results

  • After 12 months, patients who received ticagrelor+placebo vs those who received ticagrelor+aspirin had lower incidence of BARC type 2, 3 or 5 bleeding (4.0% vs 7.1%; HR, 0.56; 95% CI, 0.45-0.68; P<.001 difference percentage points ci to>
  • The difference in risk for BARC type 3 or 5 bleeding was similar between the groups  (1.0% vs 2.0%; HR, 0.49; 95% CI, 0.33-0.74).
  • The incidence of death from any cause, non-fatal MI or non-fatal stroke was 3.9% in both groups (difference, −0.06 percentage points; 95% CI, −0.97 to 0.84; HR, 0.99; 95% CI, 0.78-1.25; P<.001 for non-inferiority>

Limitations

  • Lack of power to detect differences in the risk for rare clinical events.
  • Results may not be generalisable.

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