Patient Case Presentation

1. Rerouting Anticoagulants
Evaluating the Role of Rivaroxaban Following
Revascularization for Peripheral Vascular Disease
Anna Sandler
PharmD Candidate, 2023
1

2. Learning Objectives
 Review the epidemiology, pathophysiology, and
clinical presentation of peripheral vascular disease
(PVD)
 Describe the current treatment of PVD, including
revascularization
 Identify the role of anticoagulant therapy in PVD
 Evaluate literature and apply findings to a patient
case
2

3. Patient case
MS is a 91 year old male who returns to the anticoagulation clinic for
off-site warfarin management. The patient has been taking 11.25 mg
weekly, and his home health RN reports an INR of 2.1. The patient is
instructed to continue with the same dose and return for follow-up in
three weeks.
3
09.13.2022 10.06.2022 10.18.2022-
What could the patient be
taking the warfarin for?

4. Patient case
MS returns to the anticoagulation clinic for off-site warfarin
management. The patient’s home RN calls to report recent INR
results. She states the patient has been very irritable and non-
compliant with his warfarin, taking more than instructed. The
patient does not want to take warfarin anymore.
Current
Medications
Assessment
PMH
Warfarin
dose/INR
4
• PVD s/p stent
(1/2011) and s/p
bypass graft
(2/2011)
• HLD
• Carotid Artery
disease s/p
endarterectomy
(4/2011)
• HTN
• Lisinopril 5 mg
daily
• Metoprolol 25 mg
daily
• Pentoxifylline 400
mg BID
• Warfarin
• Simvastatin 20 mg
QHS
• Irritable,
yelling at RN
• Has some small
oozing blood
from groin area
• 16.25 mg
/week
• INR 5.8
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5. Patient case
MS returns to the anticoagulation clinic for off-site warfarin
management. The patient’s home RN calls to report recent INR
results. She states the patient has been very irritable and non-
compliant with his warfarin, taking more than instructed. The
patient does not want to take warfarin anymore.
5
09.13.2022 10.06.2022 10.18.2022-
What are some potential
reasons this patient does
not want to take warfarin
anymore?

6. 6
Patient case-PVD details
1/ 2011
Stent placement
on left lower
extremity
2/ 2011
Femoropopliteal graft 2/2
stent stenosis
Started warfarin
6/2022
Arterial duplex revealed
patent femoral-femoral
bypass and occluded left
femoral to posterior tibial
graft with two vessel runoff
10/2022
Patient hospitalized for bleeding
thigh wound and potential
infection of graft, team discussing
revascularization
Patient also had an amputation of
the left second toe in 2011, date
unknown

7. Patient case
MS presents to his primary care physician after a recent visit to the
ER 2/2 bleeding from his thigh wound. Based on labs and physical
exam, patient is sent to LGH for further evaluation of acute blood
loss anemia.
Labs Physical Exam
7
• Hgb 9.2
(baseline 14)
• INR 4.8
• Pale and very
weak
appearing
• Thigh wound
still bleeding
a bit
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8. Background VOYAGER Study 2 Conclusions
8
• Chronic progressive atherosclerotic disease leading to
partial or total occlusion of peripheral vasculature
• ~ 200 million people affected globally
Peripheral Vascular Disease (PVD)
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Modernvascular. https://modernvascular.com/peripheral-artery-disease/. Accessed October 25, 2022
Risk factors
• Tobacco Use
• Diabetes
• HTN
• HLD
• > 50 y/o
• BMI > 30
• African
Americans
• Poverty
• Low education
High-risk groups

9. PVD Pathophysiology
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
https://stock.adobe.com/hu/search/images?k=peripheral+artery+disease&asset_id=494776405. Accessed
October 25, 2022
Lipoprotein
accumulation
Oxidation and
fatty streaks
Fibrous
plaque
Accumulation
Stenosis &
Occlusion
9
Background VOYAGER Study 2 Conclusions

10. Clinical Presentation
•Exercise-induced cramping, fatigue, weakness, pressure
Intermittent Claudication (IC)
•Paresthesias, lower extremity weakness, cool extremities
Altered sensations
•Pain at rest, non-healing wounds or ulcers, gangrene
Critical limb ischemia
10
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
https://blog.avinger.com/blog/peripheral-artery-disease-pad-symptoms. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions

11. Diagnosis of PVD
• Assess for known risk factors
• Ankle-brachial index (ABI) assessment
• Systolic ankle pressure/systolic brachial pressure
Normal ABI ratio: 0.9-1.2
PVD ABI ratio: < 0.9
• Duplex US for determining location and severity of stenosis
• Magnetic resonance angiography (MRA) or CTA to image
vessels and hemodynamically significant lesions
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022. 11
Background VOYAGER Study 2 Conclusions

12. Complications of PVD
12
Acute Limb Ischemia
Major amputation
Major adverse CV events
Twitter. https://twitter.com/cirbosque/status/1259513941467828226. Accessed October 28, 2022
Verywell Health. https://www.verywellhealth.com/types-of-lower-extremity-amputations-2696172.
Accessed October 28, 2022
Background VOYAGER Study 2 Conclusions

13. 13
Lifestyle
modifications
Control symptoms
Slow progression and
prevent complications
Treatment
Goals
PVD Treatment goals
Background VOYAGER Study 2 Conclusions

14. 14
•Exercise therapy
•Smoking cessation
•Cholesterol and BP control
•Blood sugar control
Risk-factor modification
•Cilostazol
•Pentoxifylline
Pharmacological for IC
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Mayo Clinic https://www.mayoclinic.org/diseases-conditions/peripheral-artery-disease/multimedia/graft-bypass/img-
20008584. Accessed October 25, 2022
Interventions:
• Revascularization
• Endovascular (lower-risk)
• Surgical/bypass (higher-risk)
• Amputation
Background VOYAGER Study 2 Conclusions

15. 15
Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016. Circulation. Accessed October 25, 2022.
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Therapy Agents Recommendation
Antiplatelet
therapies
ASA or
clopidogrel
daily
To reduce MI, stroke, or vascular death in patients with
symptomatic PVD (COR 1, LOE A)
Cholesterol
management
Statins Indicated for all PVD patients (COR I, LOE A)
IC sx control Cilostazol Effective therapy to improve sx and increase walking distance
in patients with claudication (COR I, LOE A)
IC sx control Pentoxifylline Not effective for IC tx (COR III, LOE B-R)
Anti-hypertensives ACE inhibitors
or ARBs
To reduce risk of CV ischemic events in patients with PVD
(COR IIa, LOE A)
Oral
anticoagulation
Warfarin
?DOACs
Useful to improve patency after lower extremity autogenous
vein or prosthetic bypass uncertain
(IIb, B-R)
Background VOYAGER Study 2 Conclusions

16. 16
Revascularization comes with its own
complications
• Loss of graft patency
• Severe claudication
• Limb-threatening ischemia
• Risk is 4X as high as that
among those who have
never undergone
revascularization
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Hess CN, Rogers RK, Wang TY, et al. J Am Coll Cardiol 2018; 72: 999-1011. Accessed October 28, 2022
Hess CN, Wang TY, Weleski Fu J, et al. J Am Coll Cardiol 2020; 75: 498-508. Accessed October 28, 2022
Can we modify this risk?
Background VOYAGER Study 2 Conclusions

17. Back to Patient MS
17
What do we think he is taking
warfarin for?
09.13.2022 10.06.2022 10.18.2022-

18. Clinical Question
18
If MS undergoes
revascularization, can we select
an alternative to warfarin?
09.13.2022 10.06.2022 10.18.2022-

19. https://www.jnj.com/fda-approves-expanded-peripheral-artery-disease-pad-indication-for-xarelto-
rivaroxaban-plus-aspirin-to-include-patients-after-lower-extremity-revascularization-ler-due-to-
symptomatic-pad. Accessed October 25, 2022
Background VOYAGER Study 2 Conclusions

20. A short history lesson
20
2013 (TRA2P-TIMI 50)
• Vorapaxar reduces acute
limb ischemia in PVD pts.
2013 (ROCKET-AF)
• Rivaroxaban non-inferior to
warfarin in non-valvular
afib
2017 (COMPASS)
Rivaroxaban + ASA superior
to ASA in preventing major
events in limbs
2020 (VOYAGER-PAD
2022 DOACs vs. warfarin
in high-risk bypass
Background VOYAGER Study 2 Conclusions

21. A short history lesson
21
2013 (TRA2P-TIMI 50)
• Vorapaxar reduces acute
limb ischemia in PVD pts.
2013 (ROCKET-AF)
• Rivaroxaban non-inferior to
warfarin in non-valvular
afib
2017 (COMPASS)
Rivaroxaban + ASA superior
to ASA in preventing major
events in limbs
2020 (VOYAGER-PAD
2022 DOACs vs. warfarin
in high-risk bypass
Background VOYAGER Study 2 Conclusions

22. Literature Review:
22
Rivaroxaban in Peripheral
Artery Disease after
Revascularization
Marc P. Bonaca, Rupert M. Bauersachs, Sonia S.
Anand et al. 2020
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions

23. 23
•Evaluate safety and efficacy of rivaroxaban added to
aspirin compared to aspirin alone for the prevention of
major adverse limb and CV events in patients with PVD.
Objective
•Double-blind, superiority randomized controlled trial
Design
• Rivaroxaban 2.5 mg twice daily added to aspirin 100 mg
daily
Intervention
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions

24. •>/= 50 y/o
•Documented moderate-severe symptomatic lower extremity atherosclerotic
PVD (clinically + anatomically + ABI </= 0.80/0.85 depending on prior hx of
limb revascularization)
•Successful revascularization procedure within 10 days for PVD sx
Inclusion Criteria
•Planned DAPT or long-term tx with clopidogrel
•High bleeding risk
•Hx of clinically significant bleeding within 6 months prior to randomization
•Major tissue loss in either leg
•Patients requiring tx with ASA doses > 100 mg
Exclusion Criteria
24
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions

25. 25
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Design-Randomization
Randomization
+ clopidogrel
Rivaroxaban
2.5 mg BID
Placebo
- clopidogrel
Rivaroxaban
2.5 mg BID
Placebo
1:1
1:1
Strata:
• Procedure type
• +/- clopidogrel
Background VOYAGER Study 2 Conclusions

26. 26
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Design-Outcomes
1015 events 90% power
20%
reduction
One-sided α
0.025
Outcome Description
Primary
efficacy (ITT)
Composite:
• Acute limb ischemia, major amputation for vascular
causes
• MI
• Ischemic stroke
• Death from CV causes
Safety
(On-treatment)
• Major bleeding according to TIMI, ISRH, and BARC
classifications
Background VOYAGER Study 2 Conclusions

27. 27
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Timeline
• Patients randomized Aug 2015- Jan 2018
• 542 sites, 34 countries
• North America
• South America
• Europe
• Asia
• Median f/u period: 28 months
Background VOYAGER Study 2 Conclusions

28. Results-Baseline Characteristics
28
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Groups well balanced
Rivaroxaban N= 3286, Placebo N = 3278
• Median age: 67.0
• White (%): 81
• Asian (%): 15
• HTN (%): 81
• HLD (%): 60
• Current smoker (%): 35
• T2DM (%): 40
• eGFR < 60 (%): 20
• Endovascular procedure (%): 65
• Surgical procedure (%): 35
• Carotid artery disease (%): 9
• Previous amputation (%): 6
• Previous peripheral revascularization
(%): 36
• ASA at randomization (%): 99
• Clopidogrel at randomization (%): 50
• Statin at randomization (%): 80
Background VOYAGER Study 2 Conclusions

29. Results-Primary Outcome
Endpoint Riva (N=3286) Placebo (N=3278) HR (95% CI); P
Primary
outcome
508 (15.5) 584 (17.8) 0.85 (0.76-
0.96); P 0.009
29
Primary Outcome
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Lower rate of composite
outcome in rivaroxaban
group
• NNT ~ 44
Background VOYAGER Study 2 Conclusions

30. Results-Other outcomes
30
Secondary (Hierarchical)
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Statistically significant
lower incidences of:
Safety
Unplanned
revascularization
Hospitalization for
thrombosis
Limb ischemia +
amputation + MI +
death from any
cause
Death alone not
sig. reduced
• Higher TIMI major bleeding in
rivaroxaban group, not significantly
higher
• 62 patients vs. 44 patients (HR
1.43; 95% CI 0.97-2.10; P= 0.07)
• Higher ISTH major bleeding in
rivaroxaban group
• 140 patients vs. 100 patients
(HR 1.42; 95% CI, 1.10-1.84)
• NNH ~81
Background VOYAGER Study 2 Conclusions

31. Conclusions
31
Researchers
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Early benefit of
rivaroxaban addition to
aspirin for reducing
primary composite
outcome
• Higher major bleeding
rates with addition of
rivaroxaban without
increases in intracranial or
fatal bleeding
Background VOYAGER Study 2 Conclusions

32. Strengths and Weaknesses
32
• High discontinuation rates
• Only evaluated treatment
within 10 days of
revascularization
• Evaluated WITH ASA
• Lack of comparisons to
warfarin
• Low representation
• Surgical revascularization
• Carotid artery disease
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Large, international
randomized control trial
• Endpoints independently
and blindly adjudicated
• Many comorbidities
represented
Background VOYAGER Study 2 Conclusions

33. Literature Review:
33
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Effect of Direct Oral
Anticoagulants Versus Warfarin
on Patency in High-Risk Bypass
Patients
Melissa K. Meghpara, Yi Tong, Albertina
Sebastian et al. 2022
Background VOYAGER Study 2 Conclusions

34. 34
•Evaluate efficacy of DOACS compared to warfarin during
post-op period in patients undergoing lower extremity high-
risk bypass (HRB)
•Warfarin vs. apixaban or rivaroxaban
Objective
•Single-center, retrospective pilot study
Design
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions

35. •Lower extremity HRB graft patients undergoing femoral
to above/below knee bypass with adjunct procedure, or
below knee bypass
•Redo bypass
Inclusion Criteria
•Anti-platelet therapy
Exclusion Criteria
35
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions

36. Design-Outcomes
36
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
• Demographic and comorbidity data
obtained from medical records
Outcome Description
Primary • 12-month primary bypass patency:
< 50% stenosis of arterial graft during f/u appnts
Secondary/safety • 30-day reinterventions, bleeding complications,
CV or cerebrovascular complications (stroke, MI),
need for major amputation and mortality
Background VOYAGER Study 2 Conclusions

37. Results-Baseline Characteristics
37
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Characteristic DOAC (N=26) Warfarin (N=18) P
Age (mean yrs) 69 68 0.661
Male (%): 65 61 1.000
White (%): 65 56 0.055
Black (%): 31 22 0.055
PVD (%): 92 83 0.386
HLD (%): 54 33 0.227
HTN (%): 85 83. 1.000
Previous stent (%): 50.0 50.0 1.000
Prior endarterectomy (%): 81 29 0.001
Adjunct endovascular
procedure
42.3 11.1 0.043
CAD (%): 65 28 0.031
Background VOYAGER Study 2 Conclusions

38. Results-Primary Outcome
Endpoint DOAC (N=26) Warfarin (N= 18) P (Log-
rank)
12-month
patency rate (%)
83.3 57.1 0.03
38
Primary Outcome
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
• Higher patency rates in
DOAC group
• Odds ratio after
controlling for > 30-day
reintervention: 6.59 (CI
1.06-41.09)
Length patency
DOAC
Warfarin
Probability
of
Patency
Background VOYAGER Study 2 Conclusions

39. Conclusions
39
Researchers
• No difference in post-op complications of
HRB patients with higher 12-month
patency rates in DOAC-treated patients
compared to warfarin group.
• Need for larger randomized controlled
trial to further study outcomes between
DOACs and warfarin perioperatively in
bypass patients.
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions
• No differences in post-
op outcomes and
complications between
DOAC and warfarin
patients

40. Strengths and Weaknesses
40
• Inclusion of similar
patients
• Prior stent,
bypass graft,
endarterectomy
hx
• Retrospective
• Single-center
• Low f/u rates-type I error
• Small n
• ?Underpowered
• Endovascular-oriented
era
• Some baseline differences
• More CAD in DOAC
group
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions

41. 41
Back to Our Patient
1/ 2011
Stent placement
on left lower
extremity
2/ 2011
Femoropopliteal graft 2/2
stent stenosis
Started warfarin
6/2022
Arterial duplex revealed
patent femoral-femoral
bypass and occluded left
femoral to posterior tibial
graft with two vessel runoff
10/2022
Patient hospitalized for bleeding
thigh wound and potential
infection of graft, team discussing
revascularization
Patient also had an amputation of
the left second toe in 2011, date
unknown

42. 42
Back to Our Patient 10/2022
Patient is not a candidate for
surgery due to advanced age and
debilitated state, ultimately
admitted to hospice
09.13.2022 10.06.2022 10.18.2022-
However, if MS had undergone revascularization…

43. 43
09.13.2022 10.06.2022 10.18.2022-
Rivaroxaban Indication:
On the basis of the data, I may or
may not recommend rivaroxaban for
post-revascularization
anticoagulation at this time.
UpToDate. Rivaroxaban: Drug Information. https://www.uptodate.com/contents/rivaroxaban-drug-
information?sectionName=Adult&anchor=F6724168&source=auto_suggest&selectedTitle=1~1---2~4---
rivaroxaban&showDrugLabel=true&search=rivaroxaban#. Accessed October 31, 2022.
Efficacy Safety

44. 44
09.13.2022 10.06.2022 10.18.2022-
Rivaroxaban Indication:
On the basis of the patient’s
condition, I would not
recommend rivaroxaban.
UpToDate. Rivaroxaban: Drug Information. https://www.uptodate.com/contents/rivaroxaban-drug-
information?sectionName=Adult&anchor=F6724168&source=auto_suggest&selectedTitle=1~1---2~4---
rivaroxaban&showDrugLabel=true&search=rivaroxaban#. Accessed October 31, 2022.
Efficacy
Safety

45. Thank you for your
time!
45

46. References
46
1. Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization.
N Engl J Med. 2020;382(21):1994-2004. doi:10.1056/NEJMoa200005
2. Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular
Disease. N Engl J Med. 2017;377(14):1319-1330. doi:10.1056/NEJMoa1709118
3. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients
With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12).
doi:10.1161/CIR.0000000000000470
4. Gul F, Janzer SF. Peripheral Vascular Disease. In: StatPearls. StatPearls Publishing; 2022. Accessed October
25, 2022. http://www.ncbi.nlm.nih.gov/books/NBK557482/
5. Hess CN, Rogers RK, Wang TY, et al. Major Adverse Limb Events and 1-Year Outcomes After
Peripheral Artery Revascularization. J Am Coll Cardiol. 2018;72(9):999-1011. doi:10.1016/j.jacc.2018.06.041
6. Hess CN, Wang TY, Weleski Fu J, et al. Long-Term Outcomes and Associations With Major Adverse Limb
Events After Peripheral Artery Revascularization. J Am Coll Cardiol. 2020;75(5):498-508.
doi:10.1016/j.jacc.2019.11.050
7. Meghpara MK, Tong Y, Sebastian A, et al. Effect of Direct Oral Anticoagulants Versus Warfarin on Patency in
High-Risk Bypass Patients. Ann Vasc Surg. Published online July 8, 2022:S0890-5096(22)00329-6.
doi:10.1016/j.avsg.2022.06.009

47. References
47
8. Morrow DA, Braunwald E, Bonaca MP, et al. Vorapaxar in the Secondary Prevention of Atherothrombotic Events.
N Engl J Med. 2012;366(15):1404-1413. doi:10.1056/NEJMoa1200933
9. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J
Med. 2011;365(10):883-891. doi:10.1056/NEJMoa1009638
10. Provance JB, Smolderen KG, Mao J, et al. Abstract 11211: Guideline Directed Medical Therapy After Peripheral
Vascular Intervention and One-Year Mortality in Patients with Peripheral Artery Disease in the Vascular Quality
Initiative Medicare Linked Database. Circulation. 2021;144(Suppl_1). doi:10.1161/circ.144.suppl_1.11211

48. 48
Appendix
VOYAGER PAD Trial
Design

49. Rerouting Anticoagulants
Evaluating the Role of Rivaroxaban Following
Revascularization for Peripheral Vascular Disease
Anna Sandler
PharmD Candidate, 2023
49