Efficacy in the THEMIS trial

In high-risk patients with CAD who had T2D and no history of MI or stroke

  • Primary Efficacy End Point (Composite of CV Death, MI, or Stroke) BRILINTA 60 mg plus aspirin (N=9619) vs aspirin alone (N=9601):

       

    • K-M% at 36 months, 6.9% vs 7.6%, respectively (HR 0.90; 95% CI 0.81-0.99; P=0.04)1
    • Events per 1000 patient years: 24 vs 27, respectively2
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  • The composite end point was driven by MI and stroke2
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  • BRILINTA is not indicated to reduce CV death in patients with CAD2
IN A PRESPECIFIED SUBGROUP ANALYSIS OF THE THEMIS TRIAL,

Efficacy outcomes: Patients with history of PCI

THEMIS-PCI primary efficacy end point: Composite of CV Death, MI, or Stroke3,4

THEMIS-PCI Primary Efficacy End Point
THEMIS-PCI Primary Efficacy End Point
  • In patients who did not have a history of PCI: composite of CV death, MI, or stroke (K-M%) at 36 months: 7.4% vs 7.5% with BRILINTA plus aspirin (N=4061) and aspirin alone (N=4005), respectively (HR 0.98; 95% CI 0.84–1.14)3,4
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  • BRILINTA is not indicated to reduce CV death in patients with CAD2
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THEMIS was not designed or powered to demonstrate the efficacy or safety of BRILINTA compared with placebo in specific subgroups. Subgroup analyses were performed to evaluate consistency of results in different cohorts. Analyses must be interpreted cautiously, as differences can reflect the play of chance among a large number of analyses.

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THEMIS STUDY DESIGN

THEMIS was a randomized, double-blind, placebo-controlled trial of ticagrelor vs placebo in 19,220 patients, on top of low-dose (75 to 150 mg) aspirin for the prevention of thrombotic CV events (CV death, MI, stroke). Patients ≥50 years with type 2 diabetes receiving an anti-hyperglycemic medication for at least 6 months, and with stable CAD (ie, history of PCI, CABG, or angiographic stenosis ≥50% in at least 1 coronary artery) were enrolled. Patients with known prior MI or stroke were excluded. Patients were treated for a median of 33 months and up to 58 months.1,2

ARR=absolute risk reduction; CABG=coronary artery bypass graft; CAD=coronary artery disease; CI=confidence interval; CV=cardiovascular; HR=hazard ratio; K-M=Kaplan-Meier; MI=myocardial infarction; NNT=number needed to treat; PCI=percutaneous coronary intervention; RRR=relative risk reduction; THEMIS=Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study; T2D=type 2 diabetes.

References
  1. Steg PG, Bhatt DL, Simon T, et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019;381(14):1309-1320.
  2. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
  3. Bhatt DL, Steg PG, Mehta SR et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019;394(10204):1169-1180.
  4. Steg PG, Bhatt DL, Simon T, et al. THEMIS-PCI: Ticagrelor added to aspirin in patients with diabetes and stable coronary artery disease with a history of prior percutaneous coronary intervention [presentation]. Presented at: European Society of Cardiology Congress; August 31-September 4, 2019; Paris, France.
  5. Data on file, REF-51076, AstraZeneca Pharmaceuticals LP.