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

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

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.

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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

Resource links provided by the National Library of Medicine


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



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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362659


Locations
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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
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Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Study Director: Usman Baber, MD Icahn School of Medicine at Mount Sinai
Additional Information:

Publications of Results:
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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    Key Record Dates
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:
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Atrial Fibrillation
Coronary Disease
Coronary Artery Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases