Abstract
BackgroundThe efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI).Methods and resultsThis 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/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (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 (pinteraction = 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/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies.ConclusionsOverall, 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/m2.Trial registrationThe trial has been registered with ClinicalTrials.gov, Number NCT01813435.Graphic abstract
Highlights
Body mass index (BMI) is simple to calculate and used as an indicator of general adiposity [1]
To unravel the complex intricacies of the GLOBAL LEADERS trial, the present study aims to investigate the clinical impact of body mass index (BMI) on the novel antiplatelet strategy with ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI)
Patients with a BMI < 27 kg/m2 had at 2 years follow-up a higher rate of the primary endpoint (4.4% vs. 3.8%, unadjusted HR 1.17, 95% CI 1.00–1.37, p = 0.044) and secondary safety endpoint (2.4% vs. 1.9%, unadjusted HR 1.27, 95% CI 1.02–1.57, p = 0.033) compared with those with BMI ≥ 27 kg/m2 (Table 2)
Summary
Body mass index (BMI) is simple to calculate and used as an indicator of general adiposity [1]. Obesity is well recognized as a major risk factor of cardiovascular disease (CVD) [2], numerous studies have demonstrated a paradoxical association between higher BMI and lower risk of adverse events in patients with established CVD, even after adjusting for confounding factors. In this phenomenon, dubbed the “obesity paradox” [3,4,5], patients with lower or even normal BMI have a higher risk of both ischemic and bleeding events after percutaneous coronary intervention (PCI) compared to those who are overweight [6]. Trial registration The trial has been registered with ClinicalTrials.gov, Number NCT01813435
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