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Patient Selection for Long-Term Secondary Prevention With Ticagrelor
Quick Takes
- In stable patients with prior MI, a stepwise patient selection approach evaluating bleeding and ischemic risk may be useful in identifying patients who will derive greater net benefit with long-term ticagrelor.
- Those at lower bleeding risk with at least two ischemic risk factors appeared to have the most favorable risk–benefit profile.
- This simple patient selection approach may be useful for clinicians on identifying patients who may benefit from long-term ticagrelor after MI, but further validation is needed.
Study Questions:
Which patients with prior myocardial infarction (MI) on aspirin are most likely to have a favorable risk–benefit profile with long-term ticagrelor?
Methods:
The investigators performed a post hoc exploratory analysis of patients with prior MI in the PEGASUS-TIMI 54 trial to identify those most likely to have a favorable risk/benefit profile with long-term ticagrelor. PEGASUS-TIMI 54 randomized 21,162 prior MI patients, 13,956 of which to the approved 60 mg dose or placebo and who had all necessary data. The primary efficacy endpoint was cardiovascular death, MI, or stroke, and the primary safety outcome was TIMI major bleeding; differences in Kaplan–Meier event rates at 3 years are presented. Post hoc subgroups based on predictors of bleeding and ischemic risk were merged into a selection algorithm. Patients were divided into four groups: those with a bleeding predictor (n = 2,721; 19%) and then those without a bleeding predictor and either 0–1 ischemic risk factor (IRF) (n = 3,004; 22%), 2 IRF (n = 4,903; 35%), or ≥3 IRF (n = 3,328; 24%).
Results:
In patients at high bleeding risk, ticagrelor increased bleeding (absolute risk difference [ARD], +2.3%; 95% confidence interval [CI], 0.6, 3.9) and did not reduce the primary efficacy endpoint (ARD, +0.08%; 95% CI, −2.4 to 2.5). In patients at low bleeding risk, the ARDs in the primary efficacy endpoint with ticagrelor were −0.5% (−2.2, 1.3), −1.5% (−3.1, 0.02), and −2.6% (−5.0, −0.24, p = 0.03) in those with ≤1, 2, and 3 risk factors, respectively (p = 0.076 for trend across groups). There were significant trends for greater absolute risk reductions for cardiovascular death (p-trend 0.018), all-cause mortality (p-trend 0.027), and net outcomes (p-trend 0.037) with ticagrelor across these risk groups.
Conclusions:
The authors concluded that long-term ticagrelor therapy appears to be best suited for those with prior MI with multiple ischemic risk factors at low bleeding risk.
Perspective:
This exploratory analysis reports that in stable patients with prior MI, a stepwise patient selection approach evaluating bleeding and ischemic risk may be useful in identifying patients who will derive greater net benefit with long-term ticagrelor. Specifically, those at lower bleeding risk with at least two ischemic risk factors appeared to have the most favorable risk–benefit profile. This simple patient selection approach may be useful for clinicians on identifying patients who may benefit from long-term ticagrelor after MI; however, further validation in ‘real-world’ cohorts, including those with history of gastrointestinal bleeding and in a broader population of patients, is needed.
Clinical Topics: Acute Coronary Syndromes, Prevention
Keywords: Acute Coronary Syndrome, Aspirin, Gastrointestinal Hemorrhage, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Risk Factors, Secondary Prevention, Stroke, Ticagrelor
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