CLINICAL IGNIFICANCE
- •The overall annual bleeding rate for dual antiplatelet therapy is alarming 20.3%, exhibited in 19.2% patients with acute coronary syndrome;
- •Total bleeds were associated with almost twice less deaths and myocardial infarctions, while stroke risks were identical;
- •There was no statistical correlation between bleeding severity and outcomes or differences between ticagrelor and clopidogrel.
ABSTRACT
BACKGROUND
Bleeding remains complication during dual antiplatelet therapy (DAPT) for acute coronary
syndrome (ACS). Some data suggest a link between bleeding and worsened vascular outcomes.
However, this association is unclear, due to omitting of minor bleedings when applying
conservative scales. In contrast, Platelet Inhibition and Outcomes (PLATO) trial classification utilized broad realistic capturing of all bleedings.
METHODS
Access was gained to the FDA-issued adjudication dataset on which post hoc analyses of bleeding, MI, stroke and death was conducted. Bleeding was defined as
minimal, minor, major and life-threatening or fatal (LTOF) as per the original PLATO
scale.
RESULTS
Among 18,624 enrollees, 10,705 adjudicated events occurred across 7,171 patients.
There were 618 minimal, 1,412 minor, 1,216 major and 536 LTOF bleedings for the total
of 3,782 events reported in 3,387 patients. There were 938 deaths, 2,751 MI's and
359 strokes. The overall bleeding was 20.3%, exhibited in 19.2% patients. Total bleeds
were associated with less deaths (OR (95% CI): 0.55 (0.47 – 0.63)) and MI 0.47 (0.41
– 0.54; p < 0.001 for both). There were no differences in deaths (1.11 (0.93-1.34);
p = 0.24), but less MI's (0.72 (0.59 – 0.86); p < 0.001), and more strokes (2.17 (1.64
– 2.88); p < 0.001) after LTOF. Major, minor and minimal bleeds were associated with
less deaths and MI but not strokes.
CONCLUSION
These large uniformly adjudicated data reveal that within 12-months of DAPT, one out
of five patients experiences bleeding. Overall, bleeding was associated with diminished
incidence of death and MI, but not strokes.
Keywords
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© 2022 Published by Elsevier Inc.
