Key result
Ticagrelor monotherapy did not significantly reduce the primary composite of all-cause mortality or new Q-wave myocardial infarction compared to standard therapy across BMI groups.
Why the study?
The efficacy of antiplatelet therapies following PCI may be affected by body mass index.
Does 23-month ticagrelor monotherapy following 1-month DAPT reduce all-cause mortality or new Q-wave myocardial infarction compared to 12-month aspirin monotherapy following 12-month DAPT in patients undergoing PCI, stratified by BMI?
RCT (n=15,966)
Open-label
Yes
Yes
Does 23-month ticagrelor monotherapy following 1-month DAPT reduce all-cause mortality or new Q-wave myocardial infarction compared to 12-month aspirin monotherapy following 12-month DAPT in patients undergoing PCI, stratified by BMI?
Answers are grounded in this paper and cite their sources.
BMI did not overall influence the treatment effect of ticagrelor monotherapy after 1-month DAPT, but a beneficial effect was observed in ACS patients with BMI < 27 kg/m2.
Background The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). Methods and results This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m 2 . Of those, 6973 (43.7%) patients with a BMI < 27 kg/m 2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m 2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group ( p interaction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m 2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m 2 ( p interaction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. Conclusions Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m 2 . Trial registration The trial has been registered with ClinicalTrials.gov, Number NCT01813435. Graphic abstract
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Ono et al. (2020) conducted an RCT in Percutaneous coronary intervention (PCI) (n=15,966). Ticagrelor monotherapy following abbreviated dual antiplatelet therapy vs. 12-month DAPT followed by 12-month aspirin monotherapy was evaluated on Composite of all-cause mortality or new Q-wave myocardial infarction at 2 years (BMI < 27 kg/m2 subgroup) (HR 0.82, 95% CI 0.66-1.03, p=0.09). Ticagrelor monotherapy did not significantly reduce the primary composite of all-cause mortality or new Q-wave myocardial infarction compared to standard therapy across BMI groups.
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