1. Drug-Coated Balloons in Peripheral Artery Disease
Michael R. Jaff, DO
February 25, 2013

2. Michael R. Jaff, DO Consultant Abbott Vascular (non-compensated)
American Genomics, Inc
Becker Venture Services Group
Bluegrass Vascular Therapies
Cordis Corporation(non-compensated)
Covidien (non-compensated)
Ekos Corporation (DSMB)
Hansen Medical
Medtronic (non-compensated)
Micell, Incorporated
Primacea
Trivascular, Inc.
Equity
Access Closure, Inc
Embolitech, Inc
Hotspur, Inc
Icon Interventional, Inc
I.C.Sciences, Inc
Janacare, Inc
Northwind Medical, Inc.
PQ Bypass, Inc
Primacea
Sadra Medical
Sano V, Inc.
TMI/Trireme, Inc
Vascular Therapies, Inc
Board Member
VIVA Physicians (Not For Profit
501(c) 3 Organization)

3. Drug:Device Combinations in PAD
Drug Coated Balloons
Drug Eluting Stents
(?) Bioresorbable Devices

4. DRUG COATED BALLOONS

5. Virmani, LINC 2013

6. Virmani, LINC 2013

7. Virmani, LINC 2013

8. Paclitaxel Coated Balloons for Fem/Pop Disease
Circulation 2008;118:

9. N Engl J Med 2008;358:689

10. 85 patients (91 cases) with symptomatic femoropopliteal PAD
Randomized to Paclitaxel-coated balloon (IN.PACT) (44) vs
Bare PTA Balloon (47)
Primary endpoint=Late Lumen Loss at 6 months
Angiographic core lab adjudicated
Circ Cardiovasc Interv 2012;5.

11. PACIFIER Lesion Characteristics
Circ Cardiovasc Interv 2012;5.

12. Primary Endpoint (LLL @ 6 Months)
De Novo vs ISR
Occlusion vs Stenosis
Lesion Length <10 cm vs >10 cm
Circ Cardiovasc Interv 2012;5.

13. PACIFIER TLR

14. Circ Cardiovasc Intervent 2012;5:582-9

15. Binary Restenosis
Circ Cardiovasc Intervent 2012;5:582-9 15

16. Late Lumen Loss
Circ Cardiovasc Intervent 2012;5:582-9 16 16

17. Death
Circ Cardiovasc Intervent 2012;5:582-9 17 17 17

18. 104 pts (109 limbs) treated for infrapopliteal disease CLI (82.6%)
IC (17.4%)
Mean lesion length 17.6 mm (+ 88 mm)
3 month angiographic endpoint
JACC 2011;58:1105-9

19. JACC 2011;58:1105-9

20. 3 month angiographic primary patency 72.6%
Limb salvage rate 95.6%
74.2% of ulcers healed at a mean days
JACC 2011;58:1105-9 20

21. Baseline and Mean 12.5 mo Follow Up
JACC 2011;58:1105-9 21

22. Identified Clinical Trials
SIROCCO and STRIDES included in base case, excluded in scenario analysis
† only TLR for DES arm available – we combined TLR rates for randomized controlled trial and single arm study;
* Conference publication only

23. Clinical Model Results: Freedom from TLR over 24 Months (pooled)
Per visual inspection, the mean TLR rates of DEB, DES, and BMS are substantially lower than PTA
Based on weighted pooling taking into account sample sizes of underlying trials/registries.

24. Clinical Model Results: Freedom from TLR over 24 Months (pooled)
STRIDES and SIROCCO excluded
Per visual inspection, the mean TLR rates of DEB, DES, and BMS are substantially lower than PTA
Based on weighted pooling taking into account sample sizes of underlying trials/registries.

25. Results: U.S. Budget Impact, 100% Outpatient
Medicare Perspective
Total charges* for 24 months post index-procedure
Facility Provider Perspective
Total headroom (APC – device price) for 24 mths
PTA BMS DES DEB
PTA BMS DES DEB
Assumption: DEB reimbursed at PTA rate; DES at BMS rate. * Charges= 2012 Medicare APC Schedule

26. Results: U.S. Budget Impact, 100% Outpatient
STRIDES and SIROCCO excluded
Medicare Perspective
Total charges* for 24 months post index-procedure
Facility Provider Perspective
Total headroom (APC – device price) for 24 mths
PTA BMS DES DEB
PTA BMS DES DEB
Assumption: DEB reimbursed at PTA rate; DES at BMS rate. * Charges= 2012 Medicare APC Schedule

27. Drug-Coated Balloons
Expanding body of literature demonstrating efficacy of DCB in peripheral artery disease
Potential advantages are great
No device remains
Opportunities for retreatment if needed
Combination therapy (ie atherectomy) appealing
Cost-effectiveness emerging