Ticagrelor alone was associated with less bleeding than ticagrelor plus aspirin, but aspirin alone was not evaluated

Référence

Mehran R, Baber U, Sharma SK, et al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med 2019;381(21):2032-2042.

Sommaire

The current standard of care following PCI is DAPT with aspirin and a P2Y12-inhibitor, such as clopidogrel or ticagrelor. However, DAPT is associated with an increased risk of bleeding compared with the use of a single agent. In this study, funded by the manufacturer, 9006 patients who had just undergone placement of at least one drug-eluting stent and who were at an increased risk for ischemia or bleeding were recruited. Patients with ST-elevation myocardial infarction (MI), cardiogenic shock, or who were taking an anticoagulant were excluded. The study participants entered an open-label, active run-in period where they received low-dose aspirin plus ticagrelor 90 mg twice daily for 3 months, and were excluded if they were nonadherent or if they experienced a major bleed, an MI, or a stroke. Excluding these patients likely created a bias against DAPT, especially by excluding those who had experienced an ischemic event while taking DAPT (who,in real life, would presumably not be excluded from further DAPT therapy). The remaining 7119 patients were then randomized to receive aspirin or placebo, in addition to continued ticagrelor 90 mg twice daily for 12 months. The groups were balanced at baseline with an average age of 65 years, 29% with previous MI, and 23% women. Analysis was by intention to treat for the primary bleeding and cardiovascular outcomes. A major bleed was defined as one that required a clinical action, such as a diagnostic test, treatment, or hospitalization. At one year, the likelihood of major bleeding was significantly lower in the ticagrelor-only group (4.0% vs 7.1%; P < .001; number needed to treat = 32). There was no significant difference between the groups for any of the cardiovascular outcomes, including the composite of all-cause mortality, nonfatal MI, and nonfatal stroke (3.9% for both groups).