Download Outpatient_VTE_protocol_for_Dummies_9-1

Outpatient VTE Protocol for Emergency Physicians
Jeffrey A. Kline, Daren M. Beam, Zachary P. Kahler
@klinelab
August, 2016
1. Eligibility criteria for discharge from the ED
a. All patients need a baseline creatinine and CBC within the last two weeks
b. All patients (both DVT and PE) must be modified Hestia negative or physician discretion and sPESI
negative
HESTIA
 SBP > 100 mm Hg
• No thrombolysis needed
• No active bleeding
• O2 not required to maintain sats >94% for more than 24h
• Not already anticoagulated
• No severe pain (defined as requiring > 2 doses intravenous narcotics)
• No other medical or social reasons to admit
• Creatinine clearance >30 mL/min
• Not pregnant, no severe liver disease, no history of HIT
sPESI
Physician discretion of absence of other reason for admission adequate social situation and
adherence potential, AND
 Age < 80
 No history of cancer
 No history of heart failure or chronic lung disease
 Pulse < 110 beats/min
 SBP > 100 mm Hg
 O2 sat > 90%
c.
d.
Active cancer-Recommend additional screening with the POMPE-C tool.
http://www.mdcalc.com/pompe-c-tool-for-pulmonary-embolism-mortality/
Needs to be ≤5% mortality risk
e. Caveats for PE:
i.
I personally would observe a patient with an elevated troponin for 24 hours
ii.
Look for pulmonary hypertension on ECG (S1Q3T3)
iii.
Data coming from DenExter et al out of Netherlands (AJRCCM) shows no need for BNP
iv.
Consider also requiring low-moderate bleeding risk as well (See bullet 4c)
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2. Drug dosing:
a. Apixaban 10 mg BID for 7 days, then 5 mg BID
i. Give first dose in ED
ii. Don’t have to give LMWH, but OK to get both
b. Rivaroxaban 15 mg BID for 21 days then 20 mg daily
i. Give first dose in ED
ii. Don’t have to give LMWH, but OK to get both
iii. Take with food
iv. Daily doses can be taken in the morning or evening
v. Use starter pack
c. All others (Dabigatran, Edoxaban) require heparin for 7 days
3. Drug Access and Payment:
a. PPO or Medicare + supplemental: $0
i. Occasionally still have to do prior authorizations
ii. Prior authorizations are a time consuming.
b. Medicaid: Both apixaban (Eliquis®) or rivaroxaban (Xarelto®)are preferred drugs for
most Medicaid ad
c. Medicare depends upon administrator and supplemental—copay can be a problem
d. Janssen has a 30 day voucher. 30 day Starter Pack is free with voucher.
i. http://webrebate.trialcard.com/coupon/XareltoPortal/
e. J&J Foundation will provide free drug for patients who qualify (Usually if annual income
is less than $35,640/year for a single person/ $48,060 year for family of 2).
i. Requires an NPI on file
ii. Requires an application for each patient
1. Thus, requires a case manager or social worker
f. “Counter price” for drugs for 3 months is not much different overall than 7 days of
enoxaparin
4. Questions patients want answered in ED
Why did I get this (unprovoked clot)?
A: Everybody has genes that are the master blueprint of your body’s ability to make
and dissolve blood clots. All of our genes vary slightly from person to person. You
probably inherited one or more different genes that tend to make your blood want to
clot more than other people. Also, as we get older, we tend to clot more.
When will my chest stop hurting?
A: Most patients have pain for about a week. Your pain may actually get worse over the
next two days. You can take motrin or advil for two days with your blood thinner, but
not more than two days.
When will my legs stop swelling and hurting?
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A: If you have leg swelling now, that often means you will continue to have some degree
of swelling for the rest of your life. A lot of this depends upon how bad your clot was,
your age and body weight. About half of patients get some better over the next month
and about half get no better.
What can I do to help my leg swelling?
A: Most importantly is take your medicine to prevent blood clotting (Apix or Riva). You
should walk 30 minutes every day. You can try knew high compression stockings at 3035 mm Hg (needs prescription).
Should I take aspirin with the blood thinner?
A: No.
How long will I need to take the anti-clot medicine?
A: At least 3 months for leg clots and 6 months for clots in the lungs. Men with clots in
their lungs and anyone with recurrent clots may need longer treatment.
What about the TV ads?
They are made by lawyers who want to make money. They are wrong and horrible. The
drug you are prescribed is your safest option.
5. Instructions
a. 99.9% of “reasonable and prudent care” is to ensure that the patient takes the
anticoagulant for a long enough time
b. “Take your pill, don’t not take your pill”
c. Duration of treatment probably best figured out in a clinic or by PCP
i. First time popliteal DVT = 3-6 months, usually 3
ii. Women, first time PE = 6 months
iii. Males with PE = Life
iv. Males and females with recurrent DVT = at least 6 months, if PE = life
v. Calf, brachial vein = 1-3 months
vi. Axillary vein = 3 months
vii. Femoral vein = 6-12 months
viii. Isolated subsegmental PE, no cancer, first time = 0-3 months
d. Quick rules for low-moderate bleeding risk (See Kline et al, Acad Emerg Med 2016)
i. Age <65
ii. no organ failure
iii. no prior bleeding
e. Very few patients need a thrombophilia workup (see international guidelines )
i. Almost no one with their first VTE should have one initiated
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ii. For instance, may consider workup if unprovoked VTE Age <50 and 1st degree
family member with same
f. No specific side effects
6. At clinic—patient oriented
a. Adherence issues
i. 99% are taking per label
ii. Low adherence patients were due to drug access
b. Common questions
i. Why did I get this clot?
1. Answer is whatever provoked + the genetics+ age. Probably 800 genes
affect ability to make and remove clot. We all have small variations in
some of these genes. You just have a variation that made you clot a
little too well.
ii. My leg hurts
1. Post thrombotic syndrome affects about 25% of these patients and is a
significant QOL issue.
2. Most patients get better in terms of quality of life from about month 1month 5.
3. It is too soon at the first visit to predict who will get better and who will
not.
4. Symptoms are pain worse with standing, burning at night, cramping
5. It is worth knowing components of the Villalta Score, which are on the
form (swelling, varicose and collateral veins, heme staining, ulcers)
6. Stockings have minimal effect, but may help patients who have to stand
long periods: use knee high 30-40 mm Hg compression stockings
a. Amazon.com has these for about $20
7. Exercise definitely helps, and we believe continuous moderate is best.
Flat or incline on treadmill walking 30 min per day optimal.
iii. How long do I have to take this medicine?
1. See simplified outline above
2. Shared decision making model
3. Use D-dimer to help (see below)
iv. When I come off the medicine, what should I do?
1. Everybody with proximal DVT or PE takes 81 mg aspirin per day for life
a. Maybe not for clearly provoked clot, if age <50
b. ASA not given much love in ACCP’s 10th
2. OK to take a couple of days if going overseas on a plane (no data yet)
v. Menorrhagia
1. If >10 pads in any one day, hold next dose of riva or two doses apix
a. Only hold one dose
b. If still > 10 pads/day call or go to PCP or ER
c. OK to take OCPs on anticoagulation
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2. Check a hemoglobin and peak drug Protime in clinic.
vi. Procedures
1. Teeth, colonoscopy: hold one dose riva or two doses apix
a. Tranexamic acid mouthwash may help with oral bleeding (no
data yet)
2. Ortho surgery: hold two and four doses respectively
3. All others case by case
4. Rivaroxaban half-life is 5-9 hours, apixaban is 12 hours. Yes, the dosing
makes no sense on that basis
vii. What should my family do?
1. Mostly nothing
2. For unprovoked DVT/PE patients, possibly consider option of
genotyping a daughter who is considering OCPs
viii. I want to get tested for those genes
1. Go ahead, but not here.
2. You will pay about $25K out of pocket and the doctor ordering the tests
will not tell you / may not know that in almost every case.
ix. Can I drink alcohol?
1. If you do, don’t fall down.
7. At clinic—labs and ultrasound
a. If no baseline creatinine or CBC, need one
b. No need to repeat BMP in the first year on treatment unless clinical changes in patient
c. Protime does vary proportionately to edoxaban and rivaroxaban blood concentration, if
the manufacturer uses neoplastine reagent. In all cases, peak drug INR should be <1.5.
Above that is too high.
i. I find useful for the few HIV+ patients—some need to take only 15 mg per day
ii. Menorrhagia
d. Protime useless for apixaban
e. A anti-factor Xa assay is helpful for apixaban, edoxaban, and rivaroxaban but only if
calibrated to drug-specific standards
f. D-dimer useful in two ways
i. D-dimer to guide decision to stop anticoagulation at 3 or six months but you are
worried (higher risk: unprovoked, any recurrence, obesity, advanced age,
persistent PTS, patient wants to stop despite clear risk)
1. If > 250 ng/mL (at standard cutoff) while ON therapy (like day of clinic),
we would recommend staying on because recurrence risk increased
2. Can also use to survey risk of recurrence after stopping anticoagulation
(but take 81 mg aspirin). Bring back 2 weeks later. If abnormal,
recommend going back on therapy for another 3-6 months and try
again.
g. Transition to warfarin for patients with too much income for J&J foundation and not
enough to afford drug
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i. Start warfarin 5 mg per day orally, and continue apixaban or rivaroxaban as
usual
ii. After three days, stop the apixaban or rivaroxaban
iii. Check PT sometime between days 4-7 and adjust per protocol
h. Ultrasound in clinic
i. Isolated first-time calf vein or brachial vein clots
1. My practice (JAK) is to re-ultrasound and D-dimer at first visit, if they
have had >2 weeks anticoagulation. If both negative, I stop the
anticoagulation. If either positive, 3 months. ASA optional –most no.
ii. First-time subsegmental PE.
1. Somewhat controversial, but most experts agree no treatment needed
if no DVT or D-dimer negative
2. If bilateral LE venous ultrasound was already done, then stop
anticoagulation whenever. No ASA.
3. If D-dimer was negative in ED stop anticoagulation
4. If not, do bilateral LE venous US and if negative, can stop
anticoagulation and no ASA
5. Can also stop and draw D-dimer in a month if other things worry you.
8. Follow-up
a. Goal is to get to a PCP, who can make final decision on duration
b. If ours only, then back again at 3 or 6 months and use above guidelines to decide on
stopping.
c. D-dimer is strongly supported in literature, especially when measured one month later
off drug and <500 ng/mL
d. 81 mg ASA per day for life unless contraindicated in patients age >50 or any CV risks,
such as obesity, smoking, diabetes, or any worrisome clot. Pretty much everybody.
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