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

NCT02362659 | Completed

• 3 other identifiers: GCO 14-1543-00002CV185-376PD14-03987
• Study Type: observational
• Target: 514
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation

Keywords

non-valvular; atrial fibrillation; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

  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)

  12 months

• bleeding risk

  Safety as measured by bleeding according to the Bleeding Academic Research Consortium (BARC) bleeding definitions (BARC 2,3 or 5)

  12 months

Secondary Outcomes (3)

• Net adverse clinical events

  12 months

• Association between subjective and objective measures of ischemic and bleeding risk

  12 months

• Modes of antithrombotic therapy cessation

  12 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 26678646 RESULT

• 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.

  PMID: 35656720 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Usman Baber, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: April 1, 2015
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)