Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | April 2015 |
| End Date: | November 15, 2018 |
Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI
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 with stenting 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.
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 with stenting 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 with stenting at 11
Northern American and European centers. Patients were followed for 12 months following
implantation of stent. 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.
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 with stenting at 11
Northern American and European centers. Patients were followed for 12 months following
implantation of stent. 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
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Annapoorna Kini, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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