1. Rome, 15th December 2015 Daniela Bassi Corporate Product Manager
Understanding SURVET
Rome, 15th December 2015
Daniela Bassi
Corporate Product Manager

2. Do we clearly know SURVET and re-DVT indication?

3. The Background
Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding

4. Unprovoked
When it occurred in the absence of any know risk factors for this event
Unknown origin VTE patients have a two-fold higher rate of recurrent VTE than the patients with acquired, transient risk factors!

5. High risk of recurrence
~20% within 2 years
~50% within 10 years
This does not change depending on whether anticoagulation is prolonged for 6, 12, or 24 months!!

6. Discontinuation or Extending
Low-moderate bleeding risk
Extended AC over 3 months
High bleeding risk
Stop AC at 3 months
ACCP Duration of AC in patients with a first unprovoked VTE
AC should be given for not < 3 months

7. In practice, how to choose?
The decision as to go on or discontinue AC after the first 3 months is individually tailored and balanced
Risk of recurrence
Risk of bleeding
Patients preference must also be taken into consideration!

8. Which are the eligible situations of use for Sulodexide?

9. And after 3 months, what happen?
It depends on the “balance”
INITIAL AC
from 0 to ~7 days
risk of re-VTE
>
risk of bleeding
Heparin or
LMWHs or
Fondaparinux or
NOACs (rivaroxaban, dabigatran, apixaban, edoxaban)
LONG-TERM AC
from ~7 days
to ~3 months
risk of re-VTE
>
risk of bleeding
VTKs (warfarin, acenocoumarol) or
NOACs (rivaroxaban, dabigatran, apixaban, edoxaban)
And after 3 months, what happen?

10. from ~3 months to indefinite
Scenario #1
re-VTE Risk
> Bleeding Risk
EXTENDED AC
from ~3 months to indefinite
VTKs (warfarin, acenocoumarol) or
NOACs (rivaroxaban, dabigatran, apixaban, edoxaban)
Only in case, the patient refuses AC therapy!

11. Scenario #2 Low- moderate re-VTE Risk
not supportive for a continuation of
AC treatment
…but who prefer to have a protection with an effective & safe therapy
Sulodexide may be used in patients with a risk level that does not require continuation of AC treatment but show an acceptable risk (<5%) to select a protective therapy, with lower bleeding risk.

12. from 3 / indefinite to indefinite
Scenario #3
Bleeding risk > re-VTE risk
All the situation in which the risk of bleeding and the related possible damage are bigger than the risk of recurrence.
EXTENDED AC
from 3 / indefinite to indefinite
VTKs (warfarin, acenocoumarol)* or
NOACs (rivaroxaban, dabigatran, apixaban, edoxaban)* 
Aspirin or
Sulodexide (capsules)
CRITERIA FOR EXTENDED AC: more documented VTE episodes; Active cancer; Serious thrombophilia; Antiphospholid antibody syndrome; PE with shock or life-threatening; > systolic PAP; Other indications for AC; NYHA 3 or 4

13. with existing comorbidities
Some specific cases
Elderly ≥75 years and/or
with existing comorbidities
Elderly patients have an increased risk of bleeding and hepatic and renal complications when using anticoagulant treatment and are also likely to have more comorbidities – possible drug–drug interactions must be considered
Sulodexide can be used in this population as it is not associated with an increased bleeding risk, has no known drug interactions, and does not affect renal function

14. Can we consider NOACs in our reference market ?

15. Remember that…. NOACs market has a huge dimension
More than 50% of NOACs prescriptions are in atrial fibrillation
The situation of use are not exactly the same as Sulodexide

16. Who is in charge of the VTE patient management?

17. Initiation of treatment
We need to know….
First visit
Diagnosis
Initiation of treatment
Follow-up
Who?
The management of patients with VTE appeared to be very complex and it vary somewhat between countries

18. Which target are involved?
Vascular Surgeon GP
Any Other?
Cardiologist
Hematologist
Angiologist

19. Which are the key messages from the study?

20. NO increased risk of bleeding
The main strengths
NO increased risk of bleeding
No episodes of major bleeding within 2 years in either treatment group!

21. The main strengths
TOLERABILITY

22. … and what about the posology?
Higher dosage
4 cps/day
Long term treatment
2 years
The results are guarantee only with this treatment scheme!

23. Last but not least….

24. Corporate Activities and Materials

25. SURVET Project Overview
ADVOCACY
N.2 Advisory Board
KOLs/Investigators
Kick Off Meeting
22 Oct 2015
International AB
25 Nov 2015 1 2
2015
MEDIATION
Stand Alone International Meeting
KOLs/Investigators/Local Influencers
Launch Event
12-13 April 2015 3
2016
DISSEMINATION
(International Congresses/ Local Launch events/ Advisory Boards)
International/
Local Meetings 4

26. Phases 1-2: Advocacy
STEERING COMMITTEE
Giuseppe Maria ANDREOZZI
Angelo BIGNAMINI
Giovanni DAVÍ
Gualtiero PALARETI 1
Kick Off Meeting
22 Oct 2015
ADVISORS
Andrej DŽUPINA (Slovakia)
Grzegorz MADYCKI (Poland)
Carlos MAGALHÃES MOURA (Portugal)
Jiří MATUŠKA (Czech Republic)
German SOKURENKO (Russia)
Adriana VISONÀ (Italy) 2
International AB
25 Nov 2015
KEY POINTS DISCUSSED
The SURVET study: expert advice on the results and their implications for the use of sulodexide in the prevention of VTE recurrence
The ideal patient types who would most benefit from extended treatment with sulodexide in the prevention of VTE recurrence
National perspectives on the study results, SURVET survey and types of patients suitable for Sulodexide

27. Specialists Phase 3: Launch Event To whom is addressed?
12-13 April 2015
Specialists
Local KOLs / Influencers
that will spread the SURVET Trial results
To whom is addressed?

28. Local tool ready for use
The Objectives
Disclose the SURVET results and clinical implication
Discuss new therapeutic perspective vs current treatment options
Provide clear guidance in the identification of target patients
Prepare delegates to become speakers in their own country
In long term, create a KOLs network who can help to enrich the international dialogue on the prevention and treatment of VTE
Each delegate will receive a post-deliverable resource kit
Local tool ready for use

29. Phase 4: Dissemination European Congress of Phlebology
13-17 April 2016
Rome, IT
International/
Local Meetings 4
European Venous Forum
07-09 July 2016
London, UK
World Congress of IUA
05-09 October 2016
Lyon, FR

30. SURVET Corporate Materials
Reprint Folder
Visual aid
Slide Kit

31. Do we clearly know SURVET and re-DVT indication?