Vranckx P, et al. - Ticagrelor in combination with aspirin for 1 month, followed by ticagrelor alone was evaluated in terms of improved outcomes post-percutaneous coronary intervention vs standard antiplatelet regimens. With regards to the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention, ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not found to be superior to 12 months of standard dual antiplatelet therapy, followed by 12 months of aspirin alone.

Methods

• At 130 sites in 18 countries, a randomized, open-label superiority trial called GLOBAL LEADERS was conducted.
• Participants were patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes.
• These patients were randomly assigned (1:1) to 75–100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75–100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months.
• Randomization was concealed, stratified by center and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four.
• A composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner was primary endpoint at 2 years.
• Site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5) was secondary safety endpoint.
• Intention to treat analysis was performed.

Results

• Random assignment of 7,980 participants to the experimental group and 7,988 to the control group was done between July 1, 2013, and November 9, 2015.
• Death or a non-fatal centrally adjudicated new Q-wave myocardial infarction at 2 years was reported in a total of 304 (3.81%) participants in the experimental group, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0.75–1.01]; p=0.073]).
• They found no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93).
• A total of 163 participants in the experimental group and 169 in the control group experienced grade 3 or 5 bleeding (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0.78–1.20]; p=0.77).