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

Bonaca, MP; Bhatt, DL; Simon, T; Fox, KM; Mehta, S; Harrington, RA; Leiter, LA; Capell, WH; Held, C; Himmelmann, A; Ridderstråle, W; Chen, J; Lee, JJ; Song, Y; Andersson, M; Prats, J; Kosiborod, M; McGuire, DK; Steg, PG

doi:10.1016/j.jacc.2024.03.377

Aortic & peripheral vascular disease

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

J Am Coll CardiolPublished 30 Apr 2024Secondary analysis of the THEMIS randomised trial

Primary result · Limb eventsResultHazard ratio 0.77 95% CI 0.61–0.96

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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

Methodological detailsplacebo-controlled, blinded adjudication

Placebo-controlled
Blinded adjudication

Primary result

Limb events

Hazard ratio

0.77

95% CI 0.61–0.96

P = 0.022

By group

Ticagrelor1.3%

Placebo1.6%

Ticagrelorvs Placebo

HR 0.77 (95% CI 0.61–0.96); P = 0.022

As reported in the abstract

Further findings

Outcome	← Lower risk with ticagrelor ←→ Higher risk with ticagrelor →	HR (95% CI)	P value
Limb revascularization	0.050.21520	0.79 (0.62–0.99)	P = 0.044
ALI	0.050.21520	0.24 (0.08–0.70)	P = 0.009
Limb events, by PAD at baseline (subgroup)Ticagrelorvs PlaceboWith PAD	0.050.21520	0.80 (0.58–1.11)
Limb events, by PAD at baseline (subgroup)Ticagrelorvs PlaceboWithout PAD	0.050.21520	0.76 (0.55–1.05)
	0.050.21520Hazard ratio (log scale)

Outcome	HR	P value
PAD vs no PAD in placebo recipientsPAD vs No PAD · MACE 10.7% vs 7.3%	1.48	P < 0.001
PAD vs no PAD in placebo recipientsPAD vs No PAD · limb events 9.5% vs 0.8%	10.67	P < 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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