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Real-world ACS population: Ticagrelor doesn’t lessen risks of myocardial infarction or death and may increase bleeding relative to Clopidogrel

Major bleeding after acute coronary syndrome predicts a poor outcome but is challenging to define. The choice of antiplatelet influences bleeding risk.

Major bleeding, subsequent myocardial infarction ( MI ), and all‐cause mortality to 1 year were compared in consecutive patients with acute coronary syndrome treated with Clopidogrel [ Plavix ] ( n=2491 between 2011 and 2013 ) and Ticagrelor [ Brilinta; Brilique ] ( n=2625 between 2012 and 2015 ) in 5 English hospitals.

Bleeding and myocardial infarction events were independently adjudicated by 2 experienced clinicians, blinded to drug, sequence, and year.
Bleeding events were categorized using BARC ( Bleeding Academic Research Consortium ) 3 to 5 and PLATO ( Platelet Inhibition and Patient Outcomes ) criteria and myocardial infarction by the Third Universal Definition.

The median age was 68 years and 34% were women. 39% underwent percutaneous coronary intervention and 13% coronary artery bypass graft surgery.
Clinical outcome data were 100% complete for bleeding and 99.7% for myocardial infarction.

No statistically significant difference was seen in crude or adjusted major bleeding for Ticagrelor compared with Clopidogrel ( BARC 3–5, hazard ratio [ HR ], 1.23; 95% CI, 0.90–1.68; P=0.2, PLATO major adjusted HR, 1.30; 95% CI, 0.98–1.74; P=0.07 ) except in the non‐coronary artery bypass graft cohort ( n=4464 ), where bleeding was more frequent with Ticagrelor ( BARC 3–5, adjusted HR, 1.58; 95% CI, 1.09–2.31; P=0.017; and PLATO major HR, 1.67; 95% CI, 1.18–2.37; P=0.004 ).

There was no difference in crude or adjusted subsequent myocardial infarction ( adjusted HR, 1.20; 95% CI, 0.87–1.64; P=0.27 ).

Crude mortality was higher in the Clopidogrel group but not after adjustment, using either Cox proportional hazards or propensity matched population ( HR, 0.90; 95% CI, 0.76–1.10; P=0.21 ) as was the case for stroke ( HR, 0.82; 95% CI, 0.52–1.32; P=0.42 ).

In conclusion, this observational study has indicated that the apparent benefit of Ticagrelor demonstrated in a clinical trial population may not be observed in the broader population encountered in clinical practice. ( Xagena )

Mullen L et al, J Am Heart Assoc 2021;10(8):e019467. doi: 10.1161/JAHA.120.019467.