ESC 2019 — THEMIS trials and COMPLETE show promise for secondary prevention, including with T2D


  • Emily Willingham, PhD
  • Conference Reports
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Takeaway

  • Results from THEMIS, THEMIS-PCI, and COMPLETE show promise in secondary prevention of cardiovascular (CV) disease and death, including in people with type 2 diabetes (T2D), but with caveats.
    • THEMIS: Ticagrelor+aspirin dual antiplatelet therapy (DAPT) showed benefit against ischemic events in diabetes with stable coronary artery disease (CAD), but with a major bleeding tradeoff.
      • THEMIS-PCI: In a THEMIS patient subgroup with previous percutaneous coronary intervention (PCI), the DAPT combination showed benefit against CV death, myocardial infarction (MI), and stroke, more so than in patients without previous PCI, but bleeding remained a tradeoff.
    • COMPLETE: Complete revascularization in patients with STEMI and multivessel CAD bests culprit-lesion-only PCI for reductions in risk for MI, CV death, or ischemia-related revascularization.

Why this matters

  • THEMIS: study author Deepak Bhatt of Harvard Medical School said that the drug duo looks best-suited for patients at low bleeding risk but high ischemic risk, noting that THEMIS-PCI focused on exactly that group.
    • About THEMIS-PCI, Bhatt said that patients with a stent in their past have “passed a bleeding stress test,” suggesting that this patient population is “probably where the action is” for this DAPT duo.   
  • COMPLETE: meta-analyses had suggested possible reductions in CV death or MI with complete PCI of nonculprit lesions, but studies had previously been insufficiently powered for these outcomes.

Results

  • THEMIS: primary outcome (CV death/MI/stroke), aspirin+ticagrelor vs +placebo: HR, 0.90 (P=.038).
    • Significantly more frequent major and minor thrombolysis in MI (TIMI) bleeding events with ticagrelor combination (P<.01 for all>
  • THEMIS PCI: with vs without previous PCI, primary THEMIS outcome: HR, 0.85 (P=.013). 
  • COMPLETE: for primary outcome (CV death or MI), complete PCI vs culprit lesion only: HR, 0.74 (P=.004). 

Study design

  • See links to specific trials.
  • Funding: THEMIS/THEMIS-PCI, AstraZeneca; COMPLETE, Canadian Institutes of Health Research, AstraZeneca, Boston Scientific.

Limitations

  • Varied by trial.

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