Antithrombotic strategy variability in ATrial fibrillation and obstructive coronary disease revascularized with PCI-rationale and study design of the prospective observational multicenter AVIATOR 2 registry

Abstract

Background: In the era of novel antithrombotic therapy, the optimal treatment for patients with nonvalvular atrial fibrillation (AF) or flutter undergoing percutaneous coronary intervention (PCI) is undetermined.

Study design: The AVIATOR 2 study is a multicenter prospective observational registry that will enroll approximately 2,500 patients with nonvalvular AF or flutter undergoing PCI starting March 2015 over an 18-month enrollment period. Antithrombotic therapy selection will be at the discretion of the treating physician. An integral feature of this study is the use of a smartphone-based survey to capture physician and patient perspectives regarding antithrombotic therapies after PCI. Survey-derived patient treatment concerns, perceived need, and affordability will be used to calculate the risk of non-adherence. Subjective risk for ischemic or bleeding events will be correlated with previously validated risk scores as well as observed event rates at 1, 6, or 12 months post-PCI.

Endpoints: The primary efficacy end point will be major adverse cardiac and cerebrovascular events, a composite occurrence of death, nonfatal myocardial infarction, stroke, stent thrombosis, and clinically driven target lesion revascularization at 1 year. The primary safety end point will be major bleeding as per Bleeding Academic Research Consortium criteria types 2, 3, or 5. The secondary end points will include (i) net adverse clinical events, a composite occurrence of all major adverse cardiac and cerebrovascular events, and major bleeding at 1 year; (ii) correlation between estimated subjective and objective (CHADS2, CHA2DS2-VASc, stent thrombosis score, HAS-BLED, and ATRIA scores) ischemic and bleeding risks; (iii) modes of antithrombotic therapy cessation and their impact on outcomes; and (iv) correlation between observed and expected non-adherence to treatment.

Summary: AVIATOR 2 is a real-world registry designed to evaluate ischemic and bleeding outcomes according to conventional and novel antithrombotic regimens in patients with nonvalvular AF or flutter undergoing PCI. The study will also provide insights in to physician- and patient-centered factors affecting treatment selection and adherence and their overall impact on clinical outcomes. The study is registered on clinicaltrials.gov NCT02362659.