Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry
Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry
The purpose of this observational registry was to compare the safety and efficacy of an
 antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic
 versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry
 assessed whether the antithrombotic therapy intensity would vary positively with physician
 perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether
 an inverse association would be observed with perceived bleeding risk.

 This study also evaluated the physician use of objective benefit-risk assessment scores and
 their influence on prescription of antithrombotic therapy in atrial fibrillation (AF)
 patients undergoing PCI. Additionally the study investigated whether patient perceived
 relevance and accessibility of anti-platelet and anticoagulant treatment regiments would
 predict treatment adherence and whether non-adherence would independently influence outcome.

 Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11
 sites in North America and Europe. Follow-up was done via telephone by trained research
 coordinators at each participating site at 30 days, 6 months and 12 months.
The current AHA guidelines on AF for patients undergoing PCI are non-specific as they
 recommend "low-dose aspirin (less than 100 mg per d) and/or clopidogrel (75 mg per d), which
 may be given concurrently with anticoagulation to prevent myocardial ischemic events, but
 these strategies have not been thoroughly evaluated and are associated with an increased risk
 of bleeding.

 Finding the right balance that minimizes bleeding risk and maintains anti-ischemic efficacy
 remains a complex and controversial clinical dilemma in these unique patients. The arrival of
 novel antiplatelet agents and antithrombotics on the scene has led to an exponential increase
 in the combinations that may be employed by clinicians in real-life situations. The sheer
 number of combinations means that the best APT and OAC combination based on RCT data will not
 be known for many years. It has therefore become imperative that the investigators strive to
 create better methods to gauge the comparative safety and efficacy for various antiplatelet
 and antithrombotic combination strategies in AF patients undergoing PCI. To the best of the
 investigators knowledge, no contemporary prospective registry of real-life patients with AF
 undergoing PCI exists or has been initiated to date. Additionally, the factors influencing
 physician choice of treatment strategy as well as factors predicting patient adherence in
 this population is largely unknown.

 This is a multi-center, multinational, observational prospective registry prospective
 analysis of 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern
 American and European centers. Patients were followed for 12 months. Data was collected
 prospectively. All-antiplatelet and anti-thrombotic treatment regimen were at the physicians'
 discretion. The investigators studied various combinations of antiplatelet and antithrombotic
 therapies, characterized the bleeding and ischemic risk in patients with atrial fibrillation
 undergoing PCI and determined physician and patient centered factors influencing prescription
 patterns and patient adherence.

 Patients with non-valvular atrial fibrillation who have undergone successful PCI were
 enrolled as soon as possible post procedure and no later than before discharge of the index
 admission. The treating physician (interventional or non-interventional cardiologist) that
 prescribed the anti-platelet or/and anticoagulant therapy also completed the physician
 questionnaire. A different, patient centered questionnaire was completed by the patient. The
 Principal Investigator or designee provided instructions to enrolled subjects and physicians
 on how to use the hand held electronic device or how to complete the paper questionnaire and
 clarify any questions about the questionnaires. The enrolled subjects and physicians
 themselves entered the responses to the questionnaire on the electronic hand held device or
 the paper questionnaire. Only patients with completed questionnaires were considered
 enrolled.
Inclusion Criteria:

 -  Diagnosis of non-valvular atrial fibrillation during hospitalization.

 -  Preexisting atrial fibrillation.

 -  Successful all-comer percutaneous coronary intervention:

 Procedural success is defined as a reduction of residual luminal diameter stenosis to <50%
 without in-hospital death, AMI or the need for emergency CABG.

 -  Over 18 years of age

 -  Able to provide written informed consent

 Exclusion Criteria:

 -  Atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)

 -  Valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart
 valve

 -  Women who are of childbearing potential Treatment with other investigational drugs or
 devices within 30 days before enrolment or planned use of investigational drugs or
 devices during the study

 -  Life expectancy <12 months due to non-cardiac comorbidities

 -  Active alcohol, drug abuse, psychosocial reasons making study participation
 impractical

 -  Severe renal insufficiency (calculated creatinine clearance < 30 mL/min) or dialysis

 -  Clinically overt stroke within the last 3 months

 -  Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel,
 ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin