Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary … · 2020. 7. 23. · Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease. Thursday |
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Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease
Thursday | July 23, 2020| 12:00pm - 1:00pm ESTPresenter:
Geoff Barnes, MD, MScGuest Speakers:Renato Lopes, MD
Dominick Angiolillo, MDRoxana Mehran, MD
Moderators:Tracy Minichiello, MD
Arthur Allen, PharmD, CACPDiane Wirth, ANP
PresentersGeoff Barnes, MD, MSc• Assistant Professor of Medicine, Vascular and
Cardiovascular Medicine, University of Michigan
Tracy Minichiello, MD• Professor of Medicine, University of California, San
Francisco• Chief of Anticoagulation and Thrombosis Services,
San Francisco VA Medical Center
Arthur Allen, PharmD, CACP• Anticoagulation Program Manager, VA Salt Lake City
Health Care System
Diane Wirth, ANP, CACP• Adult Nurse Practitioner, Grady Memorial Hospital• Interim Executive Director of Cardiovascular Services
and Manager of the Heart Failure Program, Grady Memorial Hospital
Renato Lopes, MD• Professor of Medicine of the Department of Medicine
of the Division of Cardiology at Duke University Medical Center, Duke Clinical Research Institute
Dominick Angiolillo, MD• Professor of Medicine with tenure status, University of
Florida Health System• Director of Cardiovascular Research, University of
Florida Health System• Program Director of the Interventional Cardiology
Fellowship Program, University of Florida Health System
• Staff cardiologist and interventional cardiologist, University of Florida Health System
Roxana Mehran, MD• Professor of Medicine, Zena and Michael A. Wiener
Cardiovascular Institute at Mount Sinai School of Medicine
• Director of Interventional Cardiovascular Research and Clinical Trials, Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine
Background• Use of dual antiplatelet therapy (DAPT) after percutaneous coronary
intervention (PCI) ↓ ischemic events• P2Y12 inhibitor (e.g., clopidogrel, prasugrel, ticagrelor)• Aspirin
• 5-7% of PCI patients have indication for anticoagulation• Atrial fibrillation, venous thromboembolism, mechanical valve
Triple Therapy More Bleeding
Circulation 2019;139:775-786
Danish nationwide cohort study
Incidence of major bleeding• Number of antithrombotic meds• Comorbidities
Strategies to Reduce Bleeding• 4 RCTs in post-PCI period
• DOAC > warfarin• Shorter duration triple therapy• Dual-therapy right away?
• Reduce bleeding without increasing thrombotic risk
JAMA Cardiology 2019 doi: 10.1001/jamacardio.2019.1880
Current Guidelines• 2019 ACC/AHA/HRS Atrial
Fibrillation• If triple therapy choose
clopidogrel (Class IIa)• If PCI + AF chose DOAC over
warfarin (Class IIa)• If triple therapy switch to
double therapy ASAP (Class IIb)
J Am Coll Cardiol. 2019 Jan 21. pii: S0735-1097(19)30209-8Eur Heart J 2018; 29:213-260
Buccheri S, Angiolillo DJ, Capodanno D. Therap AdvCardiovasc Dis 2019; 13:1753944719891688
Current Guidance: North America vs. Europe
Untested
OAC-ALONE Study
Circulation. 2019;139:604–616
Study Design:• Prospective• Multi-center• Open-label• Non-inferiority
Intended Enrollment: 2000Actual Enrollment: 696
OAC-ALONE StudyOAC Alone (n=344)
OAC + Apt (n=346)
Age 74.9 ± 0.4 75.2 ± 0.4Male 190 (55.2%) 185 (53.5%)BMI 24.3 ± 3.4 24.4 ± 3.4Hypertension 292 (84.9%) 301 (87.0%)Diabetes 152 (44.2%) 138 (39.9%)Smoker 27 (7.9%) 23 (6.7%)EF ≤40% 49 (15.2%) 60 (18.6%)Prior MI 129 (37.5%) 137 (39.6%)
OAC Alone (n=344)
OAC + Apt (n=346)
CHADS-VASc 4.6 ± 1.4 4.6 ± 1.4Number of prior stents
2 (1-3) 2 (1-3)
Drug-eluting 246 (71.7%) 240 (70.6%)Bare metal 97 (28.3%) 100 (29.4%)Left Main 23 (6.7%) 22 (6.4%)Multi-vessel 119 (34.6%) 119 (35.0%)Years since PCI 4.4 (1.8-7.7) 4.6 (2.4-7.4)
Circulation. 2019;139:604–616
OAC-ALONE Study• Warfarin – ~75% of population• DOAC – ~25% of population
• Antiplatelet regimen• Aspirin 86% of population• Clopidogrel 14% of population
Circulation. 2019;139:604–616
OAC-ALONE StudyAll-cause Death, MI, Stroke, Systemic Embolism Ischemic + Major Bleeding Events
Circulation. 2019;139:604–616
AFIRE Study Design
International Journal of Cardiology 265 (2018) 108–112
Study Design:• Multi-center• Randomized• Open-label
AFIRE Study Design
• Rivaroxaban 15mg daily• 10mg daily if CrCl 15-49 ml/min• Based on PK-PD studies in
Japanese population & J-ROCKET-AF
• “Stable CAD” No stenting or CABG within 1 year
• Follow up planned for 24-45 months
• Single antiplatelet therapy options:
• Aspirin 81-100mg daily• Clopidogrel 50-75mg daily• Prasugrel 2.5-3.75mg daily
• 5-10mg daily is typical in US
International Journal of Cardiology 265 (2018) 108–112NEJM 2019;381:1103-1113
AFIRE Study Design• Primary Endpoint
• Stroke, Systemic Embolism, MI, Unstable Angina revascularization, all-cause death
• Primary Safety Endpoint• ISTH major bleeding
• Statistical Design• Non-inferiority study
NEJM 2019;381:1103-1113
AFIRE Results• 2240 Screened 2236 Randomized 1973 completed follow up
Rivaroxaban Only (n=1107)
Riva + APT (n=1108)
Age 74.3 ± 8.3 74.4 ± 8.2Male 875 (79.0%) 876 (79.1%)Diabetes 461 (41.6%) 466 (42.2%)Smoker 146 (13.2%) 146 (13.2%)Prior PCI 781 (70.6%) 783 (70.7%)-Drug eluting 500/781 (69.2%) 477/783 (66.2%)-Bare metal 171/781 (23.7%) 171/783 (23.7%)CrCl 30-49 ml/min 300/1052 (28.5%) 293/1039 (28.2%)
NEJM 2019;381:1103-1113
AFIRE Results
NEJM 2019;381:1103-1113
Stroke, Embolism, MI, UARevasc, All-cause Death ISTH Major Bleeding
AFIRE Results
NEJM 2019;381:1103-1113
Rivaroxaban Only (n=1107)
Riva + Apt (n=1108)
HR (95% CI)
Primary Efficacy 89 (4.14) 121 (5.75) 0.72 (0.55-0.95)
MI 13 (0.59) 8 (0.37) 1.60 (0.67-3.87)
UARevasc 13 (0.59) 18 (0.84) 0.71 (0.35-1.44)
CV Death 26 (1.17) 43 (1.99) 0.59 (0.36-0.96)
Primary Safety 35 (1.62) 58 (2.76) 0.59 (0.39-0.89)
Any Bleeding 146 (7.22) 238 (12.72) 0.58 (0.47-0.71)
AFIRE Conclusions• Rivaroxaban monotherapy non-inferior to riva + antiplatelet in AF +
stable CAD patients• Cardiovascular events• Death from any cause
• Rivaroxaban monotherapy superior to riva + antiplatelet• Major bleeding
Study Strengths• Important clinical question• Randomized methodology• Few patients lost screening randomization step• Large patient population• Robust outcome measures
Study Limitation• Rivaroxaban and prasugrel doses differ from US dosing
• Open-label design potential for reporting bias
• High “loss to follow up” (~12% of randomized population)
• Study terminated early potential for over-estimating efficacy
• Mechanism for lower ischemic events in rivaroxaban monotherapy group without pre-specified causal mechanism chance finding?
• No use of DAPT (or similar) score
Group Discussion• How should these two studies inform care of AF + CAD patients in North
America?• Different patients• Different medication doses• Early termination
• At what point does a CAD patient become “stable”?• How to integrate “CAD complexity” into decision-making?• How to choose between warfarin and DOAC for AF + CAD patients?• Who was NOT randomized? Who should NOT stop DAPT?• How to discuss findings with cardiology?• How might these findings apply to VTE patients?
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Gain access to this thorough curriculum with this unique opportunity for online learning.
Faculty: Arthur Allen, PharmD; Geoff Barnes, MD; Nathan Clark, PharmD; Scott Kaatz, DO & Diane Wirth, ANP
acforumbootcamp.org
Join us for our next Webinar on COVID-19 and VTE: Breaking Down the Connection
Tuesday | August 4, 2020 | 7:00 - 8:00 PM ETin collaboration with
Hear about the most up to date information on COVID-19 from the Director of Global Infectious Diseases from Mass General Hospital, Dr. Edward Ryan and from Dr. Scott Kaatz, our AC Forum Board President, who personally experienced COVID-19 and PE.
Register Here!
Guest Speakers• Scott Kaatz, DO• Edward Ryan, MDModerator:• Rachel Rosovsky, MD
Panelists:• Geoff Barnes, MD• Sam Berkman, MD• Allison Burnett, PharmD• Geno Merli, MD• Tracy Minichiello, MD
This webinar is brought to you, in part, by the support of the following companies:
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