ANTITHROMBOTIC THERAPY IN CARDIAC VALVE SURGERY
Transcript of ANTITHROMBOTIC THERAPY IN CARDIAC VALVE SURGERY
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ANTITHROMBOTIC THERAPY IN CARDIAC VALVE SURGERY
Geoffrey Barnes, MD, MSc, FACC, FAHA, FSVMVascular and Cardiovascular MedicineUniversity of Michigan, Ann Arbor, MI@GBarnesMD
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Disclosures
Consultant: Janssen, Pfizer/BMS, Acelis Connected HealthBoard of Directors: Anticoagulation ForumGrant Funding: NHLBI, AHRQ, Blue Cross Blue Shield of Michigan
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Clinical Case• 76yo man presents to clinic to discuss aortic valve stenosis
management• Progressive dyspnea, lightheadedness, some leg edema
• PMH: COPD (no O2), HTN, DM2, arthritis• Meds: Inhalers, Lisinopril/HCTZ, metformin, Aleve, ASA
81mg• Echo: Severe aortic stenosis, normal EF• LHC: No obstructive CAD
• Key Questions:• What antithrombotic therapy will he need based on type of valve
replacement?• What strategies can be employed to reduce his bleeding risk?
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Heart Valve Disease
• Marked reduction in the risk of rheumatic heart disease in the last century
• Valvular heart disease prevalence ~ 2.5% general population
• Increases to 10% in age > 75 years
J Am Coll Cardiol. 2016 Dec 20;68(24):2670-2689.
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Types of Heart Valves Replacements
Mechanical heart valves• Strong, long lasting (20+ yrs)• Thrombogenic (anticoagulation)Bioprosthetic heart valves• Created from porcine aortic valves or bovine pericardium• Less thrombogenic (+/- anticoagulation)• Lasts ~10 to 20 years• Transcatheter Aortic Valve Replacement (TAVR)
Tip: Avoid term “prosthetic” heart valve – too ambiguous
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Antithrombotic Therapy for Heart Valve Replacement
• All present risk for thrombosis and stroke
Characteristic Higher TE Risk Lower TE Risk Material Mechanical Bioprosthetic
Design Caged-ball, tilting disc
Bi-leaflet
Position Mitral or tricuspid Aortic
Side of the heart Right Left
Time frame First 3 months > 3 months
J Am Coll Cardiol. 2016 Dec 20;68(24):2670-2689.
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Intracardiac Pressures and Thrombosis Risk
Low PressureEasy to “block up”
High PressureHard to “block up”
Tricuspid, Pulmonic, and Mitral Valves
Aortic Valve
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Antithrombotic Therapy for Mechanical Valve Replacement
Type Position Risk Factors AntithromboticTherapy
Mechanical Mitral Any mitral valve with or w/o risk factors
INR 2.5-3.5
Mechanical Aortic AF, previous TE, LV dysfunction, hypercoagulable state
INR 2.5-3.5
Mechanical Aortic No additional risk factors INR 2-3
‘On-X®’ Mechanical
Aortic No additional risk factors INR 2-3 x 90 days, then INR 1.5-2.0
Bioprosthetic Aortic orMitral
Low risk of bleeding INR 2-3 x 3-6 months
Nishimura RA, et al Circulation. 2017 Jun 20;135(25):e1159-e1195. PMID:28298458
ASA 81mg recommended for ALL mechanical valve patients
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Thrombosis Risk with Mechanical Valves
0
2
4
6
8
10
Mechanical Valve
Risk
per
100
-pat
ient
-yea
rs
No Treatment Aspirin Warfarin
Circulation. 1994;89(2):635Chest. 2012;141(2 Suppl):e576SJ Am Coll Cardiol. 1995;25(5):1111
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On-X Valve: Lower INR Goal?• PROACT trial compared two warfarin INR goals in patients
receiving aortic On-X valve • 2-3 x 3 months then INR 1.5-2.0 • 2-3 indefinitely
• All patients received aspirin 81mg daily
J Thorac Cardiovasc Surg. 2014
Apr;147(4):1202-1210..
2-3 indefinitely1.5-2.0 after 3 months
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On-X Valve: Lower INR Goal?
Outcome Control Group (INR 2-3)
Test Group (INR 2-3; 1.5-2.0) P-Value
N=190755.7 patient-years
N=185675.2 patient years
Mean INR 2.50 ± 0.63 1.89 ± 0.49 P<0.0001
Major Bleeding N (%/year)
25 (3.31) 10 (1.48) P=0.032
Ischemic StrokeN (%/year)
5 (0.66) 5 (0.74) P=0.859
All ThromboembolismN (%/year)
12 (1.59) 18 (2.67) P=0.164
Composite (MB, TE)N (%/year)
39 (5.16) 30 (4.44) P=0.539
J Thorac Cardiovasc Surg. 2014
Apr;147(4):1202-1210..
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Eikelboom JW et al. N Engl J Med 2013;369:1206-1214.
Kaplan–Meier Analysis of Event-free Survival
Dabigatran vs. warfarin in patients with mechanical AVR or MVR
Stopped early d/t excessbleeding and TE in the dabigatran arm
Dabigatran for Mechanical Heart Valves: RE-ALIGN
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Thrombosis Risk: Mechanical vs. Bioprosthetic Valves
0
2
4
6
8
10
Mechanical Valve Bioprosthetic
Risk
per
100
-pat
ient
-yea
rs
No Treatment Aspirin Warfarin
Circulation. 1994;89(2):635Chest. 2012;141(2 Suppl):e576SJ Am Coll Cardiol. 1995;25(5):1111
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Antithrombotic Tx for Valve Replacement ACC/AHA Guidelines 2021
JACC 2021;77:e25-e197
ASA – only when other indication AND low bleed risk; low quality evidence
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INR Intensity for Mechanical AVR
• MAQI2 – 6 centers in Michigan, 2009-2020• Mech AVR with 1+ “Risk Factor”
• AF, prior TE, LV EF<45%, Hypercoag state
• Outcome• Thromboembolism, any bleeding, all-cause death• ISTH major/CRNM bleeding, minor bleeding
• Results• 146 patient with mech AVR + RF on warfarin (24.7% high intensity)• TTR 60% (INR 2-3), 54% (INR 2.5-3.5)• ASA use: 78% (INR 2-3), 56% (INR 2.5-3.5)• Primary outcome: High INR HR 2.58 (1.28-5.18)• Major/CRNM bleeding: High INR HR 1.92 (0.79-4.65)• Minor bleeding: High INR HR 2.91 (1.34-6.33)
Hanigan S, Am J Cardiol (in press)
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Return to Case
• 76yo man with symptomatic aortic stenosis, no AFib
• What antithrombotic therapy?• Mechanical AVR: Warfarin INR 2-3 (no RF), no ASA
• On-X Mechanical AVR: Warfarin 2-3 x90 days, then 1.5-2.0• Bioprosthetic SAVR: Warfarin INR 2-3 x3-6 months, ASA 81
indefinitely• TAVR: DAPT or Warfarin INR 2-3 x3-6 months, ASA 81 indefinitely
• How to reduce bleeding risk?• No ASA if mechanical valve• Stop NSAID for pain relief• PPI if 2+ antithrombotic meds
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Case #2
• 69yo woman with history of atrial fibrillation who develops symptomatic mitral regurgitation, planning for surgery
• PMH: HTN, Obesity, CAD• Meds: apixaban, losartan, atorvastatin
• Does she have “valvular” AF?• What anticoagulant is safe for her stroke prevention in AF?
10/26/2021
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AHA/ACC/HRS AF Guidelines:Valvular AF
Circulation. 2014 Dec 2;130(23):e199-267J Am Coll Cardiol. 2019 Jan 21. pii:
S0735-1097(19)30209-8
2014 2019Mitral Stenosis,
ORMechanical or
Bioprosthetic Valve,OR
Mitral Valve Repair
Moderate-severe mitral stenosis
OR Mechanical heart valve
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ACC/AHA Recommendations in Valvular Heart Disease & AFib
JACC 2021;77:e25-e197
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DOACs in “Valvular” AF
J Am Heart Assoc. 2017;6:e005835. DOI: 10.1161/JAHA.117.005835Major Bleeding
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DOACs in “Valvular: AF
J Am Heart Assoc. 2017;6:e005835. DOI: 10.1161/JAHA.117.005835IC Hemorrhage
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RIVER Trial
AF + Mitral Bioprosthetic
Valve(n=1,005)
Rivaroxaban 20mg daily
(n=500)
Warfarin INR 2.0-3.0(n=505)
Follow up for 12 months
R
Primary Outcome:- Death, MACE, Major Bleeding
Outcome Measure:Restricted Mean Survival Time (RMST)- Difference in “area under the curves” between two groups
NEJM 2020;383:2117-2126
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RIVER Trial
NEJM 2020;383:2117-2126
Characteristics Rivaroxaban (n=500) Warfarin (n=505) All (n=1005)
Age (Mean±SD) 59.4±2.4 59.2±11.8 59.3±12.1
Female 311 (62.2%) 296 (58.6%) 607 (60.4%)
Diabetes 74 (14.8%) 64 (12.7%) 138 (13.7%)
Prior stroke 63 (12.6%) 66 (13.1%) 129 (12.8%)
CHF 202 (40.4%) 188 (37.8%) 390 (38.8%)
CKD 7 (1.4%) 11 (2.2%) 18 (1.7%)
Median BMI (IQR) 26.6 (23.4-29.9) 25.5 (22.8-29.3) 26.0 (23.2-29.7)
Mean CHA2DS2-VASc 2.7±1.5 2.5±1.3 2.6±1.4
Valve Implant <3 months prior 94 (18.8%) 95 (18.8%) 189 (18.8%)
Valve Implant 3mo-1yr prior 91 (18.2%) 78 (15.4%) 169 (16.8%)
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RIVER Trial
NEJM 2020;383:2117-2126
RMST Difference: 7.4 days (-1.4 to 16.3)p<0.001 for non-inferiority
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Return to Case #2
• 69yo woman with AF and mitral regurgitation planning surgery
• Does she have “valvular” AF?• No! She has native valve disease
• Can she remain on DOAC?• Yes! DOAC safe unless mechanical valve (and rheumatic mitral stenosis)
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Summary
• Valve Replacement• Mechanical: Warfarin (INR 2-3 for most), few need ASA• Bioprosthetic: Warfarin ASA• TAVR: DAPT or Warfarin ASA
• “Valvular AF”• Rheumatic MS or Mechanical valve• Ok to use DOAC for native valve disease, bioprosthetic,
TAVR
@GBarnesMD