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Secondary analysis

Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis

J Am Coll CardiolPublished

  • Secondary analysis of the THEMIS randomised trial
  • placebo-controlled
  • blinded adjudication
Read the original article ↗

Authors' conclusion

Patients with T2DM and atherosclerosis are at high risk of limb events. Ticagrelor decreased this risk, but increased bleeding.

Study context

Population
Patients with T2DM and CAD, with or without PAD at baseline1,687 (8.8%) with PAD
Participants
19,220 patients
Comparison
Ticagrelor vs placebo on top of aspirin
Primary endpoint
Limb events:
  • Acute limb ischemia (ALI)
  • Amputation
  • Revascularization
Follow-up
Median 3 years

Primary result

Limb events

Hazard ratio

0.77

95% CI 0.61–0.96

P = 0.022

By group

Ticagrelor vs Placebo
HR 0.77 (95% CI 0.61–0.96); P = 0.022

As reported in the abstract

Further findings

OutcomeHR (95% CI)P value
Limb revascularization0.79 (0.62–0.99)P = 0.044
ALI0.24 (0.08–0.70)P = 0.009
Limb events, by PAD at baseline (subgroup) — Ticagrelor vs Placebo · with PAD0.80 (0.58–1.11)
Limb events, by PAD at baseline (subgroup) — Ticagrelor vs Placebo · without PAD0.76 (0.55–1.05)
OutcomeHRP value
PAD vs no PAD in placebo recipients — PAD vs No PAD · MACE 10.7% vs 7.3%1.48P < 0.001
PAD vs no PAD in placebo recipients — PAD vs No PAD · limb events 9.5% vs 0.8%10.67P < 0.001
  • Limb events, by PAD at baseline (subgroup): interaction P = 0.81

Major adverse cardiovascular events (MACE), by PAD

No effect modification by PAD
P for interaction = 0.40

Safety

TIMI major bleeding, by PAD

No effect modification by PAD
P for interaction = 0.3239

Original publication

Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis. J Am Coll Cardiol. Published 30 April 2024. doi:10.1016/j.jacc.2024.03.377
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Summarised from the published abstract; every number is checked against it