Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial
Authors: Renato D. Lopes, Sergio Leonardi, Daniel M. Wojdyla, Amit N. Vora, Laine Thomas, Robert F. Storey, Dragos Vinereanu, Christopher B. Granger, Shaun G. Goodman, Ronald Aronson, Stephan Windecker, Holger Thiele, Marco Valgimigli, Roxana Mehran, John H. Alexander
Journal: Circulation (2019)

coronary artery disease ◼ percutaneous coronary intervention ◼ stents ◼ thrombosis W e describe the incidence, timing, and characteristics of stent thrombosis and its consequences in patients with atrial fibrillation in the AUGUS-TUS trial (Open-Label, 2×2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention) 1 who received a coronary stent during their qualifying admission (acute coronary syndrome or elective percutaneous coronary intervention [PCI]).We also discuss the randomized treatment effects of low-dose aspirin (compared with placebo) and apixaban (compared with vitamin K antagonist [VKA]) on the risk of stent thrombosis.We included patients who received a stent during their qualifying admission.We excluded patients with medically managed acute coronary syndrome (n=1097) or an unknown qualifying index event (n=19).The protocol was approved by appropriate ethics committees; patients provided written informed consent before participation.Stent thrombosis was adjudicated by a clinical events committee blinded to randomized treatment allocation and classified according to the Academic Research Consortium criteria. 2The incidence of stent thrombosis is presented as 6-month Kaplan-Meier estimates and the percentage of patients with stent thrombosis.A total of 3498 patients underwent PCI with stenting during their qualifying event.Baseline characteristics of patients with and without stent thrombosis were similar (data not shown).Overall, 57 (1.6%) stent thrombosis events occurred over 6 months.Of these, 20 (0.6%) were definite, 10 (0.3%) were probable, and 27 (0.8%) were possible.Six-month Kaplan-Meier rates of definite, definite or probable, and any stent thrombosis were 0.58% (n=20), 0.87% (n=30), and 1.67% (n=57).The majority of the definite or probable events (80%, n24/30) occurred within 30 days of PCI.Of the 30 patients with definite or probable stent thrombosis events, 18 had coronary angiography at the time of the stent thrombosis.Of these 18 events, 15 involved drug-eluting stents, 1 bare metal stent, and 2 stents of unknown type.The site of stent thrombosis was the left anterior descending artery in 12 cases, right coronary artery in 3, left circumflex artery in 1, and another unspecified vessel in 2. Of patients with stent thrombosis, 28 were taking clopidogrel and 2 were taking ticagrelor.Of patients with stent thrombosis, 21 had concurrent myocardial infarction, 16 had urgent revascularization, and 12 died the same day as the stent thrombosis.Kaplan-Meier rates of stent thrombosis by randomized treatment (apixaban versus VKA, aspirin versus placebo) are shown in Figure (A andB) and by the 4 treatment regimens in Figure (C).The number (proportion) of patients with definite or probable stent thrombosis at 6 months was 13 (0.74%) for apixaban and 17 (0.97%) for VKA (hazard ratio, 0.76 [95% CI, 0.37-1.56])and 11 (0.63%) for aspirin and 19 (1.08%) for placebo (hazard ratio, 0.58 [95% CI, 0.28-1.22]).For apixaban plus aspirin, apixaban without aspirin, VKA plus aspirin, and VKA without