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

@entity1 @entity64 @entity548 @entity63 @entity75 @entity955 @entity583 @entity204 @entity715
BACKGROUND: In the era of novel antithrombotic therapy, the optimal treatment for @entity1 with nonvalvular @entity955 ( @entity955 ) 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 @entity1 with nonvalvular @entity955 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 @entity1 perspectives regarding antithrombotic therapies after PCI. Survey-derived @entity1 treatment concerns, perceived need, and affordability will be used to calculate the risk of non-adherence. Subjective risk for @entity63 or @entity548 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 @entity204 , nonfatal @entity583 , @entity64 , stent @entity715 , and clinically driven @entity75 revascularization at 1 year. The primary safety end point will be major @entity548 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 @entity548 at 1 year; (ii) correlation between estimated subjective and objective (CHADS2, CHA2DS2-VASc, stent @entity715 score, HAS-BLED, and ATRIA scores) @entity63 and @entity548 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 @entity63 and @entity548 outcomes according to conventional and novel antithrombotic regimens in @entity1 with nonvalvular @entity955 or flutter undergoing PCI. The study will also provide insights in to physician- and @entity1 -centered factors affecting treatment selection and adherence and their overall impact on clinical outcomes. The study is registered on clinicaltrials.gov NCT02362659.
