Ticagrelor plus aspirin reduces ischemic limb events in diabetes, stable CAD: THEMIS
Among patients with diabetes and stable CAD, ticagrelor plus aspirin reduced ischemic limb events compared with aspirin alone, according to new data from the THEMIS randomized controlled trial.
The absolute risk reduction with the ticagrelor-based regimen was greatest in patients with preexisting peripheral artery disease, researchers reported.
As Healio previously reported, in the main results of THEMIS, among patients with diabetes and stable CAD but no history of MI or stroke and no high risk for bleeding, aspirin plus ticagrelor (Brilinta, AstraZeneca) reduced ischemic events but increased bleeding events at 3 years compared with aspirin plus placebo. Marc P. Bonaca, MD, MPH, associate professor and director of vascular research at University of Colorado School of Medicine and executive director of clinical research and community health at CPC Clinical Research, presented the new analysis at the virtual European Society of Cardiology Congress.
“We undertook this analysis to characterize the spectrum of limb ischemic events in patients with diabetes and coronary artery disease overall, and with or without PAD,” Bonaca said during a presentation. “We wanted to look at the effect of ticagrelor plus aspirin vs. aspirin alone on these effects and to see if those effects were consistent in those with or without peripheral artery disease.”
The analysis included 1,687 patients with PAD (mean age, 68 years; 27% women) and 17,533 patients without PAD (mean age, 66 years; 32% women).
The PAD cohort was a higher-risk group, as illustrated by patients assigned aspirin in placebo, in whom those with PAD had higher risk for CV death/MI/stroke (HR = 1.48; 95% CI, 1.2-1.81) and mortality (HR = 1.73; 95% CI, 1.38-2.17) compared with those without PAD, Bonaca said.
In the overall population, the ticagrelor group had lower risk for ischemic limb events, defined as peripheral revascularization, acute limb ischemia or vascular-driven limb amputation, compared with the placebo group (1.3% vs. 1.59%; HR = 0.77; 95% CI, 0.61-0.96), he said.
The ticagrelor group also had lower risk for peripheral revascularization (HR = 0.79; 95% CI, 0.62-0.99), acute limb ischemia (HR = 0.24; 95% CI, 0.08-0.7) and major amputation (HR = 0.63; 95% CI, 0.28-1.38), according to the researchers.
There was no interaction between those with and without PAD for the benefit from ticagrelor in ischemic limb events (P for interaction = .81), but the absolute benefit was greater in patients with PAD (ticagrelor, 7.6%; placebo, 9.5%; HR = 0.8; 95% CI, 0.58-1.11) than in patients without PAD (ticagrelor, 0.7%; placebo, 0.8%; HR = 0.76; 95% CI, 0.55-1.05), Bonaca said.
“These findings suggest that concomitant PAD in diabetes and coronary disease is an important marker of limb outcomes, and it may identify a population that could particularly benefit from long-term ticagrelor, because not only do they get the [major adverse CV event] benefit, but a large limb benefit,” Bonaca said during the presentation.
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Bonaca MP, et al. Late-breaking science in cardiovascular pharmacotherapy. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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