Ticagrelor monotherapy reduces bleeding events among patients receiving percutaneous coronary intervention (PCI) who are at high risk for ischemic or bleeding events, regardless of BMI, compared with ticagrelor plus aspirin. These findings were published in JACC: Cardiovascular Interventions.
The TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) study was a randomized, placebo-controlled trial conducted at 187 sites in 11 countries. Patients (N=7038) receiving PCI with 1 or more drug-eluting stents who were at high risk for ischemic or bleeding events received 3 months of open-label 90 mg ticagrelor twice daily and 81 to 100 mg aspirin once daily. The patients who tolerated the dual antiplatelet therapy (DAPT) regimen were randomly assigned in a 1:1 ratio to receive open-label ticagrelor plus aspirin or placebo for 12 months. The primary endpoint was Bleeding Academic Research Consortium (BARC) events.
The patient population comprised 23.8% women, 30.5% were not White, their mean age was 63.9 (SD, 10.2) years, 42.3% had a previous PCI, and 64.6% had a PCI indication of acute coronary syndrome. Stratified by normal (BMI, 18.5-24.99; 25.7%), overweight (BMI 25-29.99; 41.6%), and obese (BMI, ³30; 32.7%) status, all baseline characteristics differed significantly between groups (all P £.017) except for the rates of peripheral artery disease, previous myocardial infarction, and previous major bleeding.
During PCI, 72.8% had radial artery access, the average number of vessels treated was 1.3 (SD, 0.5), the number of lesions treated was 1.5 (SD, 0.7), the total stent length was 39.8 (SD, 24.1) mm, minimum stent diameter was 2.8 (SD, 0.5) mm, and 32.7% had a complex PCI. Stratified by BMI, the patients with normal BMI had more lesions treated, a larger total stent length and minimum stent diameter, and more had complex PCI compared with overweight or obese groups (all P £.016).
At 1 year, the rate of BARC 2, 3, or 5 bleeding events was 5.7% for the normal and overweight cohorts and 5.3% for the obese group (P =.830). The composite outcome of death, myocardial infarction, or stroke occurred among 3.8% of the normal, 3.7% of the overweight, and 4.2% of the obese groups (P =.680).
Stratified by BMI and treatment, monotherapy was preferred for reducing BARC events among all patients (hazard ratio [HR] range, 0.48-0.63) and among obese patients for reducing BARC 3 or 5 events (HR, 0.25), Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries moderate or severe events (HR, 0.41), and International Society on Thrombosis and Hemostasis major events (HR, 0.29) compared with DAPT. No significant treatment-by-BMI interactions were observed. No treatment was preferred for reducing ischemic events stratified by BMI.
Net adverse clinical events were lower among the obese monotherapy recipients (HR, 0.67) compared with obese DAPT recipients.
This study is a subgroup analysis, and may be underpowered to detect significant differences.
“Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories,” the study authors wrote.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Kunadian V, Baber U, Pivato CA, et al. Bleeding and ischemic outcomes with ticagrelor monotherapy according to body mass index. JACC Cardiovasc Interv. Published online October 3, 2022. doi:10.1016/j.jcin.2022.07.039