Key result
Antiplatelet therapy with aspirin (response rate 68.3%; 95% CI 52.3-80.9%) or ticagrelor (68.8%; 95% CI 50.4-82.6%) failed to achieve adequate platelet inhibition in nearly one-third of COPD patients.
Why the study?
The study was designed to investigate whether antiplatelet therapy produces predefined cut-offs of platelet inhibition in patients with COPD without prior cardiovascular disease.
Does antiplatelet therapy (aspirin, ticagrelor, or both) improve platelet inhibition in patients with COPD without prior cardiovascular disease?
RCT (n=120)
Double-blind
2x2 factorial
Does antiplatelet therapy (aspirin, ticagrelor, or both) improve platelet inhibition in patients with COPD without prior cardiovascular disease?
Nearly one-third of COPD patients without prior cardiovascular disease do not achieve adequate platelet inhibition with aspirin or ticagrelor, suggesting a high pro-thrombotic milieu.
Questions efficacy of standard antiplatelet regimens for primary prevention in COPD; challenges assumptions from non-COPD populations and supports trials of alternatives.
The APPLE COPD-ICON2 trial is a prospective 2×2 factorial, double-blinded proof-of-concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) without prior history of cardiovascular disease. The primary goal of this trial is to investigate if treatment with antiplatelet therapy will produce the predefined cut-off of platelet inhibition measured using the Multiplate test in COPD patients. Eligible patients were randomised to aspirin plus placebo, ticagrelor plus placebo, aspirin plus ticagrelor or placebo only for 6 months. The primary outcome comprises inhibition (binary response) of arachidonic acid- (ASPI test, cut-off <40) and adenosine diphosphate- (ADP test, cut-off <46) induced platelet aggregation at 6 months. 543 patients were screened and 120 patients were recruited with mean age of 67.5 years; 47.5% patients were male. The per-protocol ASPI test response rate to aspirin was 68.3% (95% CI 52.3-80.9%). The per-protocol ADP test response rate to ticagrelaor was 68.8% (95% CI 50.4-82.6%). Platelet response to antiplatelet therapy with aspirin and ticagrelor was not observed in nearly one-third of COPD patients without prior history of cardiovascular disease. These findings support the high pro-thrombotic milieu and the need for further research to determine the effect of antiplatelet/antithrombotic therapy on cardiovascular morbidity and mortality in COPD patients.
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Kunadian et al. (2019) conducted an RCT in chronic obstructive pulmonary disease (COPD) without prior history of cardiovascular disease (n=120). Antiplatelet therapy (aspirin, ticagrelor, or both) vs. Placebo was evaluated on inhibition (binary response) of arachidonic acid- and adenosine diphosphate-induced platelet aggregation at 6 months. Antiplatelet therapy with aspirin (response rate 68.3%; 95% CI 52.3-80.9%) or ticagrelor (68.8%; 95% CI 50.4-82.6%) failed to achieve adequate platelet inhibition in nearly one-third of COPD patients.
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