Clinical trial NCT02362659: Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry
Official title: Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: non-valvular
atrial fibrillation
percutaneous coronary intervention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2015-02-13
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern American and European hospital centers.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 months
measure: bleeding risk
timeFrame: 12 months
Secondary outcomes:
measure: Net adverse clinical events
timeFrame: 12 months
measure: Association between subjective and objective measures of ischemic and bleeding risk
timeFrame: 12 months
measure: Modes of antithrombotic therapy cessation
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Usman Baber, MD
role: STUDY_DIRECTOR
References:
citation: Chandrasekhar J, Mastoris I, Baber U, Sartori S, Schoos M, Bansilal S, Dangas G, Mehran R. 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. Am Heart J. 2015 Dec;170(6):1234-42. doi: 10.1016/j.ahj.2015.08.023. Epub 2015 Sep 21.
citation: Chandrasekhar J, Baber U, Sartori S, Goel R, Nicolas J, Vogel B, Snyder C, Kini A, Briguori C, Witzenbichler B, Iakovou I, Sardella G, Marzo K, DeFranco A, Stuckey T, Chieffo A, Colombo A, Shlofmitz R, Capodanno D, Dangas G, Pocock S, Mehran R. Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry. EuroIntervention. 2022 Oct 7;18(8):e656-e665. doi: 10.4244/EIJ-D-21-01044.