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Venous Thromboembolism
UPDATES AND GUIDELINES
Steve Zanders, DO FCCP Intensivist
UNECOM ’99
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Disclosures
None
Still Short
Proud to be a UNECOM graduate (1999 !!!)
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M E N U
Impact Factor... why this is important for PCCs
Changes/Updates in Guidelines..Well , ... some
Case Discussion
Pharmacopoeia
Peri-Procedural
Unanswered and Rhetorical Questions
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Impact Factor
Why is this so important ?
Occurs often in OP setting
Follow up with PCP
New anticoagulants
The all too familiar “Family” consult
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Case
42 YO Female
with HER2+ Breast CA
Lupus Anticoagulant +
Renal Failure (CKD 4--Crt 2.4)
Mechanical AVR 10 yrs. ago
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42 YO WF with HER2+ Breast CA, Mechanical AVR 10 yrs ago
10 day ICU course after influenza
Pneumonia, VAP
Picc Line placed for long-term Abx
Recently discharge from hospital
Here for follow-up with PCP
•RUE Swollen and“Uncomfortable”
8 Weeks pregnant
!!
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9th Edition
Strong Emphasis on Patient/Family Input, Values and Preference
Restriction in Outcome Data and Risk Stratification (VTE, Bleeds)
First time article on diagnosis of VTE
Evaluation of outcomes/risks important to Patients
Reduction in Volume, 1A Grades and Recommendations
Methodological education to topic leaders (GRADE)
Excluding experts with financial AND Intellectual COI
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9th Edition
Increased Range of Interventions Covered
Summary of findings tables offering decidedly succinct but informative
Less Staunch...Exclusion of “strong opinions”
“Front-Line” Physicians on Panel (not involved with research)
ASA As DVTP--OMG
Plane Rides and Such?
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Guidelines . . .
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Health State Utility ... aka “patient preference”
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Health State Utility ... aka “patient preference”
HSU typically assessed on a scale of 0 to 1.
0=equivalent or worse health; 1= optimal health.
Subjective:A patient or participant’s utility value reflects
his or her opinions or attitudes toward a given health
state or outcome
Analog scales; Standard Gamble; Time Trade Off; Prob.
Trade-off; Decision Aids; Scenario; Interviews/Surveys
Disutility refers to the burden or negative outcomes
associated with a particular health state
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Patient Values and Preference
Condition (#48) Outcome Considered Preference
Atrial Fibrillation (16) Mixed, VKA/ASA
Stroke vs. Bleed (GI,other) Bleed better than Stroke
VTE/DVT Prophylaxis (5) DVT/VTE, PTS/PPS vs Bleed
(any) Variable
Stroke and MI Prophylaxis (4) ASA:
M,m CVA vs. Bleed Variable: ASA > CV events
Stroke/MI Thrombolytic (6) TX vs. None vs. Bleed Bleed better than Stroke
Tx Burden (17) Prophylaxis: all types vs Burden
of Prophylaxis IPC worse than SQ Injection
Mixed VKA
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Conclusions...
Pts. would rather have GI bleed vs. Stroke (2:1-3:1)
Pts. might probably would rather an MI than GI bleed (1:1-2:1)
Pts. equivocal for bleed vs. DVT
Pts. would rather have PTS/PPS than death from bleed
VKA minimally invasive to QOL, but still concerned
Aversion to VKA’s wanes...
SubQ injections better than compressive wear
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Conclusions...
Small number of studies, Small “n”, methodological
limitations
Large variability findings, appreciable heterogeneity
Values and preferences vary significantly
Previously treated vs. Never treated
Cognitive dissonance
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Lines, travel and bearers
Out-pt., Cancer, Central Line (Picc): No prophylaxis
But...if VTE + CVC {Heparinoids(2B); VKA(2C)}--Keep catheter in if needed.
Chronic Illness, immobile at home/NH: No Prophylaxis (2C)
Long-Distance Travel, risk of VTE: Exercise, aisle seating, below knee GCS
15-30 mmHg. No ASA, anticoagulants even if + for thrombophilia
“We suggest that health-care providers who manage oral anticoagulation
therapy should do so in a systematic and coordinated fashion, incorporating
patient education, systematic INR testing, tracking, follow-up, and good
patient communication of results and dosing decisions.”
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Pharmacopeia
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The New . . .
Anticoagulants
Antithrombotics
Antiplatelets
AntiFibrinoids
Drugs That Might Make You Not
Clot, Coagulate or Allow Platelets to Make
Fibrin so That Bad Things Don’t Happen
Anticlotters
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The New Antithrombotic Drugs
New AntiCoagulants-Definitions
Direct Thrombin Inhibitors:
Univalent: Only Bind at Active Site Thrombin: Argatroban (IV);
Dabigatran (Pradaxa, PO)
Bivalent: Bind Actively and at Exosite I Complex: Hirudin/oids
(Bival..Lepir...Desirudin)
Inhibit Propagation of Coagulation
Indirect Thrombin Targeting
Xabans
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The New...”Blood Thinners”...
Negative Side-Effect Profiles
Drug Trials and Results Actual Patient Outcomes
Decreased Responsiveness Over Time
Variability in Patients, Genotypes, Other Medication Use, Co-Morbid Conditions
Especially in ASA and Thienopyridines
Costs, Labs, Patient Dissatisfaction/compliance (VKA)
RE-LY trial: INR >2 >67%--Stroke 5-6%; <2, >50%--Stroke 12%
Reversal Agents, PLEASE...
=
What’s Wrong With What We Have. . . ?
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The New Oral Anticoagulants (NOACs)
VTE 3rd leading cause of death (vascular)
>15,000 patients in new OAC trials
Multiple countries Involved
Warfarin still needed
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Ok, So why should I use them ?
Good . . .
Rapid onset
Shorter t1/2
Less Interactions
Monitoring
No Dose Adjustments
Unfamiliarity
Uncertainty
Unreversible
Newbie
Cost
HUS Evaluations Equivocal
BAD VS
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The ...xAbans...Direct XA Inhibitors
Drug/® Indications (FDA) Status
Rivaroxaban/Xarelto Tx: DVT/PE(11/12); NV-Afib (11/11)
Proph: DVT (knee, hip) (7/11) Reduce Recurrence DVT/PE: (11/12)
FDA Approved for Indications FDA Rejected use for stents (8/13)
Apixaban/Eliquis NV-Afib Approved 12/2012
Edoxaban/Lixiana Proph: DVT, Lower Limb
Tx: VTE, includ. PE DVT Proph.: Japan 2011
NEJM: Sept 1, 2013
Betrixaban Proph: VTE, In-Hosp/OP ????????
Phase III Trials: Portola Merck withdrew interest 3/2011
Otamixaban CAD Withdrawn, Sanofi 2013
Darexaban Afib CAD
DVT/PE Proph Astella Withdrew 9/2011
Andexanet Alpha/PRT4445 Bleeding
Antidote for Direct Xa Inhibitors Phase III Trials
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Hey,....What about that Dibigalieloxtrabaxan-Pradaxa drug??!!!
(Dabigatrin)
Direct Thrombin Inhibitor
FDA Approved for Non-Valvular AFib
Recent Request for VTE Submitted to FDA
Post-Marketing Bleed ??
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Dabigatran (Pradaxa ®)
RE-LY (Randomized Evaluation of Long-Term Anticoagulant
Therapy)
150 mg BiD: Reduced Stroke, Similar Bleed vs Warfarin
110 mg BiD: Stroke = Warfarin, Less Bleed vs Warfarin (No
US FDA Approval)
75 mg BiD dose approved for Severe CKD (CrCL 30-50
mL/mn)
VTE: Unapproved but now used--Knee/Hip VTE prophylaxis--
220 mg in US
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Dabigatran (Pradaxa ®), Xabans
Cons
Overall, NOT better than Warfarin if INR stable
Doubled risk of major GI Bleed, especially Lower
Cannot use in renal failure (CrCl < 30 mL/mn)
Mechanical Heart Valves: Not studied/approved
Tartaric Acid base= GI upset
No sure laboratory test
Pt. Compliance: BiD dosing, Non-monitored
Cost
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Issues Related to All New OAC
• Dabigatran
Thrombin Clotting Time (TCT): Linear except at low doses (prolongs)
If “nl” : Probably safe
aPTT/ACT: Curvilinear Dose Response, Subject to Lab issues, ?Screening?
2 X’s = Peak drug level (chronic)
1.5 X’s = 12 hours
PT/INR Insensitive
Ecarin Clotting Time (ECT): Specific for Thrombin Generation: In Development
Hemoclot Thrombin Inhibitor (HTI): In Development
Testing Hemostatic Function
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Issues Related to All New OAC
PT/INR/aPTT: Not sensitive, may be good screening tool
Anti-Factor Xa assay predicts [C] but not effect
Need specific drug for calibration
In Development
Therapeutic Drug Levels ?=? Bleeding
Antidote
Testing Hemostatic Function
Factor Xa Inhibitors: ....Xabans
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Dabigatran (Pradaxa ®), Xabans
PROS
Good for Unexplained Warfarin Control
Less Strokes with 150 mg dose
Less CNS Bleeds
Drug Interactions--< Warfarin
P-Glycoprotein Transport Inhibitors/Inducers
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Issues Related to All New OAC
Conversion...
To Convert from Warfarin to NOAC: Stop Warfarin; INR <2.3 (3)-Start
Convert from NOAC to Warfarin: Warfarin Needs 5 days; Check INR D 3
Don’t use POCT
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How do I Put this thing in Reverse ??!! Managing Bleeding
Dabigatran
Hold
Measure Creatinine
Mild bleed-Watch/Wait
Severe/Life-threatening:
Charcoal
IR
PCC’s; rFVIIa:
Dialysis
Rivaroxaban
Hold
Check Crt, LFT’s
Mild-Watch/Wait
Severe/Life-threatening:
Not Dialyzable
PCC (3, 4 soon)
Antidote--Phase II
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Clopidogrel (Plavix)Prasugrel (Effient)Ticagrelor
(Brilinta)Ticlopidine (Ticlid)
Abciximab (ReoPro)Eptifibatide (Integrilin)Tirofiban (Aggrastat) Adenosine RUI
Terutroban Pecotamide
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Target
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Updated Guidelines
Hey, What About Good Ol’ Aspirin?
Most widely Researched >100 randomized trials (high-risk patients)
Reduced vascular death by 15%, nonfatal vascular events by 30%. (Overall
net benefit=20-25% reduction)
Dosing: Well done studies have shown:
Effective (long term) range b/t 50 and 100 mg/d, ?? 30 mg/d??
Dose requirements EQUAL any clinical settings
Afib? : Warfarin/OAC > ASA (inc. clopidogrel)
DVT? :
Orthopedics: Yes, but Heparin/oids Preferred
Surgery: Similar to Orthopedics
Non-Surgical: Appears Non-inferior--need larger studies
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Peri-Procedural
ISSUES RELATED TO ALL NEW OAC
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Peri-Procedure
Approximately 6 million people on anticoagulant therapy
Significant number on dual therapy (VKA/ASA,
ASA/Thienopyridine)
Bleeding risks with/out procedures
Yearly, 10% undergo procedures which require adjudication
of therapy
Data governing consensus is limited, usually single-centered
What do we do with anti-coagulation during procedures?
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Global Thrombotic Risks...
Recent VTE, No Anticoagulation: Early risk 50%
Highest risk of recurrence: first 30 days
Treatment reduces risk approximately 10% in first 30 days
Risk further decreases to 4-5% after 90 days
Arterial Embolic Disease
0.5-1%/day in first month after initial event
Fatal or significant neurologic event occurs ~60%
Afib, no valve disease = embolic event 4-5%/yr (no anticoagulation)
Risk reduced by greater than 60% on anticoagulation
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Peri-Procedure
Easy Answers
High Risk Pt/Low Bleed Risk Continue AntiCoagulant
Low Risk Pt/High Bleed Risk Hold Anti-Coagulant
Difficult Answers
High Risk Pt/High Risk Bleed
Moderates?
Elective, Urgent, Emergent?
Recent Trials : To Bridge or Not to Bridge?!
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Bleeding Risks
In General
Procedures
Thrombosis Risks
Scoring Systems
Disease Based
Assessing Risks
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Guidelines
Stop 5 days before procedure (1C); Restart 12-24 hrs later (2C)
MHValve, A-fib, VTE (Embolic) @ High Risk: Bridge (2C) CHADS2
Bridge with UFH or LMWH
MHValve, A-fib, VTE Low Risk: No Bridge (2C)
“In-Betweeners”: Assess risk, procedure, patient preference
Minor Dental: Continue, Pro-Hemostatic agent OR Stop 2-3 days before
VKA’s
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Guidelines
Minor Dental/Derm/Cataract: Continue ASA (2C)
Moderate-High Risk for CV events: Non-Cardiac---Continue (2C)
Low Risk: Stop 7-10 days prior to procedure(2C)
CABG?: Continue ASA (2C)
other Anti-Platelets: Stop 5 Days before (2C)
Dual Anti-Platelet: Delay procedure 6 wks BMS, 6 mos: DES (1C)
Dual Therapy and Urgent/Emergent Procedure: Continue (2C)
Aspirin
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Pre-Procedure--NOAC’s
Remember Characteristics
• No bridging required, usually
• Urgent, Emergent--Wait, or....
Testing
Guidance by manufacturer
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Assuring Safety...
Anti-coagulation and Procedures
Communication ALL providers
Advanced planning
Assess risk of VTE
Assess risk of bleeding
Involve patients in decisions
Prevent premature cessation of meds ( AntiPlt & Stents)
Conservative discontinuation and reinitiation
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?? ??
??
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References, Studies
• GH Guyattt, et al :Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines; CHEST 2012;
141(2)(Suppl):7S–47S
1. The RISC Group. Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease. Lancet. 1990;336(8719):827-
830
2. Juul-Möller S, Edvardsson N, Jahnmatz B, Rosén A, Sørensen S, Omblus R; The Swedish Angina Pectoris Aspirin Trial (SAPAT) Group. Double-blind trial of aspirin in primary prevention of
myocardial infarction in patients with stable chronic angina pectoris. Lancet. 1992;340(8833): 1421-1425.
3. The SALT Collaborative Group. Swedish Aspirin Low- Dose Trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events. Lancet. 1991; 338(8779):1345-1349.
4. Lindblad B, Persson NH, Takolander R, Bergqvist D. Does low-dose acetylsalicylic acid prevent stroke after carotid surgery? A double-blind, placebo-controlled randomized trial. Stroke.
1993;24(8):1125-1128.
5. Diener HC, Cunha L, Forbes C, Sivenius J, Smets P, Lowenthal A. European Stroke Prevention Study. 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci.
1996;143(1-2):1-13.
6. Landolfi R, Marchioli R, Kutti J, et al; European Collaboration on Low-Dose Aspirin in Polycythemia Vera Investigators. Efficacy and safety of low-dose aspirin in polycythemia vera. N Engl J
Med. 2004;350(2):114-124.
7. NSAIDs (including aspirin): Secondary prevention of gastroduodenal toxicity: UpToDate Individual Web - Steve Zanders,DO FCCP |Support Tag: [0604-23.24.13.233-E9CFD1052C-6.12.14-
178591516]
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Diagnosis--Lower Extremity DVT (LEDVT)
Test based on Pre-test Probability, No Uniform Test (2B)
Well’s Criteria: Not validated in outpatient setting
Clinical exam not predictive
What about Distal DVT’s: Recheck if probability high, treat based on HUS
No D-Dimer if probability high and Venogram no longer required
Recurrence? Evaluate based on clinical scenario
Pregnant? Pretest, D-Dimers and Compression
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Diagnosis--Upper Extremity DVT (UEDVT)
Secondary more common than de novo( 5-10% of all VTE’s)
Still has risks (5-10%)
Well’s Criteria: No validated in outpatient setting nor for UEDVT
Clinical exam not predictive--based on catheters, swelling, pain
Diagnosis not gold-standard (even for venograms)
Few studies and most answers extrapolated from LEDVT
Tx: To Remove or Not Remove Catheter, Then Tx