What question did this study set out to answer?

November 11, 2019Circulation

Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial

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Why the study?

The incidence, timing, characteristics, and consequences of stent thrombosis, and the effects of aspirin versus placebo and apixaban versus VKA, were investigated in patients with AF undergoing coronary stenting.

Does low-dose aspirin and apixaban reduce the risk of stent thrombosis in patients with atrial fibrillation undergoing coronary stenting compared to placebo and VKA?

Key Points

To determine the incidence, timing, and clinical impact of stent thrombosis in patients with atrial fibrillation undergoing coronary stenting, comparing the effects of apixaban versus vitamin K antagonists and aspirin versus placebo.
Analyzed patients enrolled in the randomized AUGUSTUS trial who received a coronary stent during admission for acute coronary syndrome (ACS) or elective percutaneous coronary intervention (PCI).
Assessed two randomized comparisons in a two-by-two factorial design: low-dose aspirin versus placebo, and apixaban versus a vitamin K antagonist.
Excluded patients who received medical management without stenting (n=1097) and those with an unknown qualifying index event (n=19).
Evaluated the randomized treatment effects of apixaban compared with vitamin K antagonists on the incidence of stent thrombosis.
Assessed the randomized impact of low-dose aspirin compared with placebo on stent thrombosis risk and related outcomes.
Characterized the clinical timing, presentation features, and ischemic consequences following post-stenting thrombotic events.

Structured PICO

Does low-dose aspirin and apixaban reduce the risk of stent thrombosis in patients with atrial fibrillation undergoing coronary stenting compared to placebo and VKA?

Population

Patients with atrial fibrillation (AF) who received a coronary stent during their qualifying admission (acute coronary syndrome [ACS] or elective percutaneous coronary intervention [PCI]) in the AUGUSTUS trial. Excluded: medically-managed ACS (n=1097) or unknown qualifying index event (n=19).

Intervention

Low-dose aspirin and apixaban

Comparator

Placebo (for aspirin) and vitamin K antagonist [VKA] (for apixaban)

Outcome

Incidence, timing, and characteristics of stent thrombosis and its consequenceshard clinical

Implication

Stent thrombosis data in stented AF patients informs risk awareness; leaves open effects of aspirin and apixaban strategies.

Abstract

We describe the incidence, timing, and characteristics of stent thrombosis and its consequences in patients with atrial fibrillation (AF) in the AUGUSTUS trial1 who received a coronary stent during their qualifying admission (acute coronary syndrome [ACS] or elective percutaneous coronary intervention [PCI]) and 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 ACS (n=1097) or an unknown qualifying index event (n=19). The protocol was approved by appropriate ethics committees; patients provided written informed consent prior to participation.