The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

Abstract

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.Masafumi Ono and Ply Chichareon contributed equally to this work. Electronic supplementary materialThe online version of this article (https ://doi.

Associations of body mass index, fasting insulin, and inflammation with mortality: a prospective cohort study

“…Obesity is associated with an increased prevalence and incidence of many noncommunicable chronic diseases (NCDs) including end-stage kidney disease [1,2], type II diabetes [3], cardiovascular disease [3,4], atrial fibrillation [5], nonalcoholic steatohepatitis [6], and colorectal cancer [7][8][9][10]. However, among populations with these NCDs the risk of mortality is often lower for those with obesity [1][2][3][4][5][6][7][8][9][10]. It is also associated with a lower risk of mortality among elderly people and those who are critically ill [11][12][13].…”

Aspirin-free antiplatelet regimens after PCI: insights from the GLOBAL LEADERS trial and beyond

“…In line with previous studies, the ‘obesity paradox’ was again observed with a reverse J-shape association between mortality risk and body mass index (BMI). 19 There was no treatment effect on the primary endpoint in patients with low (<27 kg/m 2 ) or high (≥27 kg/m 2 ) BMI. In patients with ACS, however, the primary endpoint was significantly reduced with the experimental strategy in patients with a BMI <27 kg/m 2 , which was not observed in those with a BMI ≥27 kg/m 2 .…”

P2Y12 Inhibitor Monotherapy after Percutaneous Coronary Intervention

“…The prespecified [ 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 ] and selected post-hoc analyses [ 57 , 58 , 59 , 60 , 61 ] performed by the GLOBAL LEADERS investigators for exploring the effect size of the intervention on different subgroups are shown in Table S1 .…”