Patients undergoing percutaneous coronary intervention (PCI) for either stable coronary artery disease (CAD) or acute coronary syndromes (ACS) who received ticagrelor without concomitant aspirin saw no benefits over conventional dual antiplatelet therapy, according to the results of a study presented at the European Society of Cardiology Congress in Munich, Germany, and simultaneously published in The Lancet.
All-cause death and new Q-wave myocardial infarction were recorded from patients with either stable CAD or ACS undergoing PCI in the GLOBAL LEADERS trial (ClinicalTrials.gov Identifier: NCT01813435), an open-label randomized superiority trial. Participants were randomly assigned to receive either experimental or control treatment.Experimental treatment consisted of 75 to100 mg aspirin daily in combination with 90 mg ticagrelor twice daily for 1 month followed by 90 mg ticagrelor twice daily for 23 months. Control treatment consisted of standard treatment: 12 months of dual antiplatelet therapy consisting of 75 to100 mg aspirin daily in combination with either 75 mg clopidogrel daily or 90 mg ticagrelor twice daily followed by 75 to100 mg aspirin daily for 12 months. Patient follow-up visits were scheduled at 30 days and 3, 6, 12, 18, and 24 months following the procedure.
Of the 15,968 participants enrolled in the study, 7980 were randomly assigned to the experimental group and 7988 to the control group. At 2 years, 77.6% of patients in the experimental group and 93.1% of patients in the control group adhered to the protocol-mandated antiplatelet treatment strategy. The primary end point was not statistically significant. All-cause mortality or new Q-wave myocardial infarction occurred in 3.81% of participants in the experimental group and 4.37% in the control group (P =.073). In addition, definite stent thrombosis or investigator-reported Bleeding Academic Research Consortium grade 3 or 5 events did not differ significantly between groups.
The study investigators wrote, “Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to standard 1-year dual antiplatelet therapy followed by aspirin monotherapy in terms of the composite end point of all-cause mortality or new Q-wave myocardial infarction after percutaneous coronary intervention.”
They added, “Although the rate of serious adverse events did not differ significantly between the two groups, discontinuation of the treatment regimen was more common in the experimental group than in the control group.”
Disclosures: The study was funded by AstraZeneca, Biosensors, and The Medicines Company.
Vranckx P, Valgimigli M, Jüni P, et al. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial [published online August 27, 2018]. Lancet. doi:10.1016/S0140-6736(18)31858-0