PEGASUS-TIMI 54: Long-term ticagrelor benefits patients with history of MI, diabetes, PAD

CHICAGO — Two subanalyses of the PEGASUS-TIMI 54 study of stable patients with prior MI showed that ticagrelor reduced major adverse CV events in patients with a history of diabetes or peripheral artery disease, according to data presented at the American College of Cardiology Scientific Session.

Both sets of results were simultaneously published in the Journal of the American College of Cardiology.

Ticagrelor and diabetes

Deepak L. Bhatt, MD, MPH , FACC, Chief Medical Editor of Cardiology Today’s Intervention, senior investigator for the TIMI Study Group and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center, and colleagues analyzed the efficacy and safety of ticagrelor (Brilinta, AstraZeneca) in subgroups of patients from the PEGASUS-TIMI 54 trial (6,806 with diabetes, 14,355 without diabetes). The primary efficacy endpoint was major adverse CV events and the primary safety endpoint was TIMI major bleeding. Median follow-up was 33 months.

Deepak L. Bhatt

According to the results, the absolute risk reduction for major adverse CV events was higher in patients with diabetes than in those without (diabetes, 1.5%; 3-year number needed to treat, 67; no diabetes, 1.1%; 3-year number needed to treat, 91). For patients with diabetes who required pharmacological therapy (n = 5,960), the absolute risk reduction was 1.9% and the 3-year number needed to treat was 53. TIMI major bleeding associated with ticagrelor increased in patients with diabetes (HR = 2.56; P = .0004) at a rate similar to patients without diabetes.

Relative risk reduction with ticagrelor was similar in patients with diabetes (HR = 0.84; 95% CI, 0.72-0.99) and patients without diabetes (HR = 0.84; 95% CI, 0.74-0.96; P for interaction = .99), according to the researchers. Of note, there was a significant reduction in cardiac-related deaths with ticagrelor in the diabetic subgroup.

Ticagrelor and PAD

In another subgroup analysis, Marc P. Bonaca, MD, MPH, investigator for TIMI Study Group and associate physician in cardiovascular medicine at Brigham and Women’s Hospital, and colleagues analyzed the effect of ticagrelor on patients with PAD (n = 1,143). Primary outcomes were occurrence of major adverse CV events and major adverse limb events.

Marc P. Bonaca

According to the results, patients with PAD assigned ticagrelor had a greater major adverse CV events absolute risk reduction of 4.1% (number needed to treat, 25). The absolute excess of TIMI major bleeding associated with ticagrelor was 0.12% (number needed to harm, 834).

Compared with those assigned ticagrelor, patients assigned placebo had a higher rate of acute limb ischemia (1% vs. 0.1%) and peripheral revascularization (9.15% vs. 0.46%), and ticagrelor was associated with reduced risk for major adverse limb outcomes (HR = 0.65; 95% CI, 0.44-0.95).

“Because of their heightened ischemic risk, patients in the subgroup analysis with a prior MI and PAD appear to have a higher absolute risk reduction with ticagrelor than those without. These findings may be helpful to clinicians in identifying patients with prior MI who they feel could benefit from prolonged therapy with ticagrelor,” Bonaca said in a press release. – by Tracey Romero

References:

Bhatt D, et al. Highlighted Original Research: Stable ischemic heart disease and the year in review.

Bonaca M, et al. Highlighted Original Research: Vascular medicine and the year in review.

Both presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Bhatt D, et al. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2016.03.529.

Bonaca M, et al. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2016.03.524.

Disclosures : PEGASUS TIMI-54 was funded by AstraZeneca. Bhatt reports financial relationships with multiple pharmaceutical, medical device and publishing companies. Bonaca reports receiving consulting fees from AstraZeneca, Bayer, Merck and Roche Diagnostics.