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Even when CABG-related bleeding events were considered, the net clinical benefit significantly favored prasugrel compared with clopidogrel at both 30 days and 15 months.
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The occurrence of bleeding events was considered within the 24 h following pleural procedure performance.
Because there was no significant difference between major bleeding events in both the intervention and the control groups in the RECORD trials [ 15], the costs of major bleeding events were not considered in our analysis.
In the 440 patients, 67 (15%) bleeding events were reported, but only 19 (4%) were considered SBEs (using the definitions from PROWESS [ 2]).
Similarly, the impact of major bleeding events was not considered in the analysis because no difference in rates of major bleeds was observed in the PLATO trial (11.6% for ticagrelor versus 11.2% for clopidogrel, P=0.43).
Major bleeding events were centrally adjudicated.
Bleeding events were similar between groups.
The bleeding events were recorded throughout the observation period.
Bleeding events were classified into 3 categories: (1) International Society of Thrombosis and Hemostasis major bleeding, (2) clinically relevant nonmajor bleeding requiring medical attention, and (3) nuisance bleeding not requiring medical attention (eg, bruising, hemorrhoidal bleeding).
When bleeding events were analysed as ordinal data (no bleed, minor bleed, major bleed)[19], significantly increased rates were seen in the triple therapy group (p<0.01).
Adverse bleeding events were also examined.
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