Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry

• ClinicalTrials.gov Identifier: NCT02362659
• Recruitment Status: Completed
• First Posted: February 13, 2015
• Last Update Posted: May 7, 2019
• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease
Non-valvular Atrial Fibrillation

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 514 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Official Title: Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI
• Actual Study Start Date: April 2015
• Actual Primary Completion Date: November 15, 2018
• Actual Study Completion Date: November 15, 2018

Groups and Cohorts

Group/Cohort
Antiplatelet agent plus anticoagulant; an antithrombotic regimen comprising one single antiplatelet agent plus an anticoagulant
DAPT alone; an antithrombotic regimen consisting of dual antiplatelet therapy (DAPT) alone
DAPT plus anticoagulant; an antithrombotic regimen consisting of DAPT plus anticoagulant therapy

Outcome Measures

Primary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: 12 months ]
   Efficacy as measured by composite of All-cause death, non-fatal MI, stroke, stent thrombosis, clinically driven target lesion revascularization at 1 year - MACCE (major adverse cardiovascular and cerebrovascular events)
2. bleeding risk [ Time Frame: 12 months ]
   Safety as measured by bleeding according to the Bleeding Academic Research Consortium (BARC) bleeding definitions (BARC 2,3 or 5)

Secondary Outcome Measures :

1. Net adverse clinical events [ Time Frame: 12 months ]
   Net adverse clinical events (NACE) - composite occurrence of all MACCE and major bleeding.
2. Association between subjective and objective measures of ischemic and bleeding risk [ Time Frame: 12 months ]
   Ischemic events assessed by CHADS, CHA2DS2-VASc is a non-valvular AF thromboembolism risk score.
3. Modes of antithrombotic therapy cessation [ Time Frame: 12 months ]
   Modes of antiplatelet and antithrombotic therapy cessation: discontinuation (physician recommended), interruption (e.g. for surgery/procedures), disruption (non-recommended)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Bristol-Myers Squibb

Investigators

• Principal Investigator: Roxana Mehran, MD; Icahn School of Medicine at Mount Sinai
• Study Director: Usman Baber, MD; Icahn School of Medicine at Mount Sinai

More Information

Additional Information:

Publications of Results:

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.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT02362659
• Other Study ID Numbers: GCO 14-1543-00002; CV185-376 ( Other Identifier: BMS ); PD14-03987 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
• First Posted: February 13, 2015
• Last Update Posted: May 7, 2019
• Last Verified: May 2019

Keywords provided by Icahn School of Medicine at Mount Sinai:

non-valvular; atrial fibrillation; percutaneous coronary intervention

Additional relevant MeSH terms:

Atrial Fibrillation; Coronary Disease; Coronary Artery Disease; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases