Addendum of Newer Anticoagulants To The SIR Consensus Guideline

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STANDARDS OF PRACTICE

Addendum of Newer Anticoagulants to the SIR


Consensus Guideline
Indravadan J. Patel, MD, Jon C. Davidson, MD, Boris Nikolic, MD, MBA, Gloria M. Salazar, MD,
Marc S. Schwartzberg, MD, T. Gregory Walker, MD, Wael E. Saad, MD, for the Standards of
Practice Committee, with Cardiovascular and Interventional Radiological Society of Europe
(CIRSE) Endorsement
Appropriate periprocedural management of the hematologic parameters in
a patient undergoing percutaneous image-guided intervention is highly
complex, considering the wide range of procedures and patient demographics. This is further complicated by both the use of short-term and
long-term anticoagulants and the increasing use of antiplatelet agents and
other medications. Unfortunately, there is currently a general paucity of
objective medical data regarding the periprocedural management of
patients with abnormal coagulation parameters.
In the absence of strong evidence regarding periprocedural
management of this patient category, members of the Standards of
Practice Committee of the Society of Interventional Radiology (SIR)
have proposed general recommendations that may be useful to the
practicing interventionalist. The various classes of medications that
affect patient coagulation parameters were critically reviewed. When
the evidence of literature was weak, conflicting, or contradictory,
consensus for the parameter was reached by a minimum of 12
Standards of Practice Committee members by using a modified Delphi
consensus method (1). For the purposes of these documents, consensus
is defined as 80% Delphi participant agreement on a value or
parameter.
A time lapse of 5 half-lives of a particular agent (equivalent to about
3% of residual drug activity from the initial dose) is frequently used as a
means of normalizing a patients bleeding risk (2,3). However, the use of
laboratory coagulation thresholds is preferable, as half-lives may vary
considerably in individual patients due to factors such as the potential
presence of drug-drug interactions, idiosyncratic factors, differences in
drug metabolism, or genetic influences. Additionally, the exact time point
of drug discontinuation may be uncertain or unreliable. Nevertheless,
when appropriate laboratory coagulation parameters are unavailable,
disproportionally costly, or logistically cumbersome, the use of 5 halflives to normalize bleeding risk can be adequate.
In this table formatted document, we summarize some of the
current medications and available literature regarding periprocedural
coagulation parameter surveillance and medical management of
patients undergoing percutaneous image-guided procedures (Tables 1
and 2). Because of the lack of randomized controlled studies or other
high-level evidence on this topic, a Delphi panel of experts constructed

a set of consensus guidelines to serve as a reference for the practicing


interventionalist. Although it is likely that individual practice parameters will vary from this document, each practitioner should monitor
outcomes and look for trends, both positive and negative, which may
suggest modifications or adjustments to these parameters. For example,
the risk of a cardiovascular or thromboembolic event must be weighed
against the risk of bleeding for a given patient undergoing a specific
procedure. For that reason, the management of patients undergoing
image-guided interventions is a continually evolving paradigm, with
local factors, such as procedure type and patient selection, influencing
these general consensus guidelines.

From the Department of Radiology (I.J.P., J.C.D.), University Hospitals of


Cleveland, Cleveland, Ohio; Department of Radiology (B.N.), Stratton Albany
Medical Center, Albany, New York; Department of Imaging (G.M.S.), Vascular
Imaging and Intervention, Harvard Medical School, Boston; Section of
Cardiovascular Imaging and Intervention (T.G.W.), Massachusetts General
Hospital, Boston, Massachusetts; Radiology Associates of Central Florida
(M.S.S.), Leesburg, Florida; Department of Radiology (W.A.S.), University of
Virginia Health System, Charlottesville, Virginia. Received December 10,
2012; accepted December 10, 2012. Address correspondence to
J.C.D., Society of Interventional Radiology, 3975 Fair Ridge Dr, Ste 400,
North, Fairfax, VA 22033.; E-mail: jon.davidson@uhhospitals.org

This report is an addendum to the prior SIR Standards of Practice publication


entitled Consensus Guidelines for Periprocedural Management of Coagulation Status and Hemostasis Risk in Percutaneous Image-guided Interventions. The authors very much appreciate Drs. Vyacheslav Gendel and
Michael L. Censullo for highlighting the need for reviewing the newer
medications encompassed here. Their input triggered preparation and rapid
publication of this report.

This article first appeared in J Vasc Interv Radiol 2009; 20:S240S249

J Vasc Interv Radiol 2013; 24:641645

This document was endorsed by CIRSE in the first version.

http://dx.doi.org/10.1016/j.jvir.2012.12.007

REFERENCES
1. Fink A, Kosefcoff J, Chassin M, Brook RH. Consensus methods:
characteristics and guidelines for use. Am J Public Health 1984; 74:
979998.
2. Douketis JD, Berger PB, Dunn AS, et al. The perioperative management of antithrombotic therapy: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;
133:299S339S.
3. Munster T, Furst DE. Pharmacotherapeutic strategies for diseasemodifying antirheumatic drug (DMARD) combinations to treat rheumatoid arthritis (RA). Clin Exp Rheumatol 1999; 17:S29S36.
4. Patel IJ, Davidson JC, Nikolic B, et al. Consensus guidelines for the
periprocedural management of coagulation status and hemostasis risk in
percutaneous image-guided interventions. J Vasc Interv Radiol 2012; 23:
727736.
5. Ferraris VA, Ferraris SP, Saha SP. Antiplatelet drugs: mechanisms and
risks of bleeding following cardiac operations. Int J Angiol 2011; 20:118.
6. Braunwald E, Antman EM, Beasley JW, et al. American College of
Cardiology; American Heart Association. Committee on the Management
of Patients With Unstable Angina. ACC/AHA 2002 guideline update for
the management of patients with unstable angina and non-ST-segment
elevation myocardial infarctionsummary article: a report of the American College of Cardiology/American Heart Association task force on
practice guidelines (Committee on the Management of Patients With
Unstable Angina). J Am Coll Cardiol 2002; 40:13661374.

None of the authors have identified a conflict of interest.


& SIR, 2013

642

Category 1
Procedure Nontunneled venous catheter

Tests

2
Angiography (arterial intervention with access
size up to 7-F)
Dialysis access interventions
Venous interventions
Central line removal
Chemoembolization/radioembolization
IVC filter placement
Uterine fibroid embolization
Venography
Transjugular liver biopsy
Catheter exchange (biliary, nephrostomy, abscess drainage catheter) Tunneled venous catheter
Thoracentesis
Subcutaneous port device placement
Paracentesis
Abscess drainage
Thyroid biopsy
Biopsy (excluding superficial and renal)
Joint aspiration/injection
Percutaneous cholecystostomy
Superficial aspiration, drainage, and/or biopsy
Enteric tube placement, initial
(excluding intrathoracic or intraabdominal sites)
Spinal procedures (vertebroplasty, kyphoplasty,
lumbar puncture, epidural injection, facet
block)

3
TIPS

INR: recommended
aPTT: recommended
Platelet count: not routinely recommended
Hematocrit: not routinely recommended

INR: recommended
aPTT: recommended
Platelet count: recommended
Hematocrit: not routinely recommended

INR: recommended
aPTT: recommended
Platelet count: recommended
Hematocrit: not routinely recommended

INR: correct to r 1.5


Platelets: r 50,000/mL recommend transfusion
aPTT: no consensus (trend toward correcting for
values Z 1.5 control, 73% consensus)

INR: correct to r 1.5


Platelets: r 50,000/mL recommend transfusion
aPTT: correct so that value is r 1.5 control

Thresholds INR: correct to r 2.0


Platelets: r 50,000/mL recommend transfusion
aPTT: no consensus

Renal biopsy
Radiofrequency ablation
Nephrostomy tube placement
Biliary interventions (new tract)

SIR Consensus Guideline: Newer Anticoagulants

Table 1 . Periprocedural Coagulation Parameter Surveillance and Medical Management of Patients Undergoing Percutaneous Image-Guided Procedures

Patel et al

JVIR

Withhold 1 dose or 12 h before


procedure

Fondaparinux

Do not withhold

Withhold 24 h before procedure

 aPTTtrend toward correcting


for values Z 1.5 control, 73%
consensus
Withhold 1 dose or 12 h before
procedure
Withhold
 23 d (CrCl Z 50 mL/min)

 35 d (CrCl r 50 mL/min)

 aPTT r 1.5x control

2013

LMWH (therapeutic dose)

No consensus

No consensus
 Check aPTT

 INR r 1.5
Withhold 5 d before procedure

May

Heparin (unfractionated)

 INR r 1.5
Do not withhold

Do not withhold

Category III Procedure


(Significant Bleeding Risk/
Bleeding Difficult to Detect)
Withhold 5d

Number 5

Aspirin*

Category II Procedure
(Moderate Risk of Bleeding)
Withhold 5d

Medications
Warfarin (Coumadin)

Category I Procedure
(Low Bleeding Risk)
Withhold 35d
 INR r 2.0

Volume 24

Table 2 . Current Medications and Management Recommendations (411)

Withhold 2 doses or 24 h before


procedure
Withhold

 23 d (CrCl Z 50 mL/min)
 35 d (CrCl r 50 mL/min)

Thienopyridines*
Clopidogrel (Plavix)*
Prasugrel (Effient)*
Ticlopidine(Ticlid)*

Withhold for 05 d before procedure

Withhold for 5 d before procedure

Withhold for 5 d before procedure

Withhold for 7 d before procedure

Withhold for 7 d before procedure

Do not withhold

Do not withhold

Withold 24 h before procedure

Do not withhold

Do not withhold

Withhold 23 d before procedure

Do not withhold

Do not withhold

Withhold 10 d before procedure

Withhold for 05 d before procedure


NSAIDs

Short-acting (half-life 26 h)






Ibuprofen






Naproxen
Sulindac

Diclofenac
Ketoprofen

Indomethacin
Intermediate-acting (half-life 715 h)

Diflunisal

Celecoxib
Long-acting (half-life 4 20 h)

 Meloxicam
 Nabumetone
 Piroxicam
(Continued)
643

644

Table 2 . Current Medications and Management Recommendations (411) (Continued)

Category II Procedure
(Moderate Risk of Bleeding)

Category III Procedure


(Significant Bleeding Risk,
Bleeding Difficult to Detect)

Glycoprotein IIb/IIIa inhibitors


Long-acting
 Abciximab (ReoPro)

Withhold 1224 h before procedure

Short-acting

Withhold immediately before


procedure

 Eptifibatide (Integrilin)
 Tirofiban (Aggrastat)

 aPTT r 50 s
 ACT r 150 s

Withhold 24 h before procedure

 aPTT r 50 s
 ACT r 150 s
Withhold 4 h before procedure

Withhold 24 h before procedure

 aPTT r 50 s
 ACT r 150 s
Withhold 4 h before procedure

Direct thrombin inhibitors


Argatroban

Do not withhold

Bivalirudin (Angiomax)

Do not withhold

Defer procedure until off medication.


If procedure is stat. or emergent,
withhold 4 h before procedure.
Defer procedure until off medication.
If procedure is stat. or emergent,
withhold

 23 h (CrCl Z 50 mL/min)
 35 h (CrCl r 50 mL/min)
Dabigatran (Pradaxa)

Do not withhold

Defer procedure until off medication.


If procedure is stat. or emergent,
withhold

 23 d (CrCl Z 50 mL/min)
 35 d (CrCl r 50 mL/min)

Defer procedure until off medication.


If procedure is stat. or emergent,
withhold 4 h before procedure.
Defer procedure until off medication.
If procedure is stat. or emergent,
withhold
 23 h (CrCl Z 50 mL/min)

SIR Consensus Guideline: Newer Anticoagulants

Medications

Category I Procedure
(Low Bleeding Risk)

 35 h (CrCl r 50 mL/min)
Defer procedure until off medication.
If procedure is stat. or emergent,
withhold

 23 d (CrCl Z 50 mL/min)
 35 d (CrCl r 50 mL/min)

There was an 80% consensus on each of these recommendations unless stated otherwise. The management recommendations for each coagulation defect and drug assume that no
other coagulation defect is present and that no other drug that might affect coagulation status has been administered.
1-Deamino-8-D-arginine vasopressin may be indicated before image-guided procedures in patients with haemophilia and von Willebrands disease (1213).
*One can and should afford exception to emergency procedures. Likewise, patients unable to safely discontinue anticoagulation for any number of medical reasons, including but
not limited to, recent coronary or cerebrovascular stents can and should be afforded a degree of variance from the guidelines above.
Patel et al

ACT=activated clotting time, aPTT=activated partial thromboplastin time, CrCl=creatinine clearance, INR=international normalized ratio, IVC=inferior vena cava, LMWH=lowmolecular-weight heparin, NSAIDs=nonsteroidal anti-inflammatory drugs, TIPS=transjugular intrahepatic portosystemic shunt.

JVIR

Volume 24

Number 5

May

2013

7. Fox KA, Mehta SR, Peters R, et al. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for nonST-elevation acute coronary syndrome: the Clopidogrel in
Unstable angina to prevent Recurrent ischemic Events (CURE) trial.
Circulation 2004; 110:12021208.
8. Lee LY, DeBois W, Krieger KH, et al. The effects of platelet inhibitors
on blood use in cardiac surgery. Perfusion 2002; 17:3337.
9. Dyke C, Bhatia D. Inhibitors of the platelet receptor glycoprotein IIb-IIIa
and complications during percutaneous coronary revascularization: management strategies for the cardiac surgeon. J Cardiovasc Surg (Torino)
1999; 40:505516.
10. Gogarten W, Vandermeulen E, Van Aken H, et al. Regional anaesthesia
and antithrombotic agents: recommendations of the European Society of
Anaesthesiology. Eur J Anaesthesiol 2010; 27:9991015.

645

11. Wann LS, Curtis AB, Ellenbogen KA, et al. ACCF/AHA/HRS focused
update on the management of patients with atrial fibrillation (update on
dabigatran): a report of the American College of Cardiology/American
Heart Association task force on practice guidelines. J Am Coll Cardiol
2011; 57:13301337.
12. Mannucci PM, Ruggeri Z, Pareti F, Capitanio A. 1-deamino-8-arginine
vasopressin: a new pharmacological approach to the management of
haemophilia and von Willebrands disease. Lancet 1977:869872.
13. Mannucci PM. Desmopressin (DDAVP) in the treatment of bleeding
disorders: the first 20 years. Blood 1997; 90:25152521.

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