5 Year Results from the IN.PACT SFA Randomized Trial
John R. Laird, MD
Adventist Heart and Vascular Institute
St. Helena, CA
DisclosuresJohn R. Laird
• Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
• Affiliation/Financial Relationship Company
• Consulting Fees/Honoraria Boston Scientific, Medtronic, Abbott, Bard/Becton
Dicksenson Peripheral Intervention, Philips
• Scientific Advisory board/stock options Reflow Medical, Endoluminal Sciences,
Syntervention, PQ Bypass, Eximo Medical,
Shockwave Medical, NexGen
Board Member VIVA Physicians
Background• Numerous randomized trials with drug-coated balloons (DCBs) have shown
improved outcomes of DCB over PTA2-10
• Published results of the IN.PACT SFA Trial have demonstrated superiority of the IN.PACT™ Admiral™ DCB over percutaneous transluminal angioplasty (PTA)2,7,8
• Long-term data from randomized trials for DCBs available in the U.S. is limited
1. Medtronic IFU M052624T0001_rev1H.2. Schneider P et al. Circ-CI 2018;11:1-15.3. Rosenfield K et al. NEJM 2015;373:145-53.4. Laurich C. LEVANT 2 Two-Year Results. SVS 2015.
5. Krishnan P et al. Circulation 2017;136:1102-1113.6. Mathews SJ. ILLUMENATE US Two-Year Results.
NCVH 2018.7. Tepe G et al. Circ 2015;131:495-502.
8. Laird JR et al. JACC 2015;66:2329-2338.9. Schneider P. IN.PACT SFA Four-Year Results. VIVA
2017.10. Laird JR. IN.PACT SFA Five-Year Results. VIVA 2018.
Primary Patency
1-Year 2-Year 3-Year 4-Year 5-Year
IN.PACT SFA IN.PACT™ DCB
87.5%1 79.0%1 69.5%2 Not assessed after 3 years
Levant IILutonix™* DCB
73.5%3 58.6%4 Not Reported Not Reported Not Reported
ILLUMENATE USStellarex™* DCB
82.3%5 72.1%6 Not Reported Not Reported Not Reported
1-Year 2-Year 3-Year 4-Year 5-Year
CD-TLR
IN.PACT SFA IN.PACT™ DCB
2.4%7 9.1%8 15.2%2 23.4%9 25.5%10
Levant IILutonix™* DCB
12.3%3 18.0%4 Not Reported Not Reported Not Reported
ILLUMENATE USStellarex™* DCB
7.9%5 Not Reported Not Reported Not Reported Not Reported
3
IN.PACT SFA Trial*Overview
1. VasCore DUS Core Laboratory, Boston, MA, US; 2. SynvaCor Angiographic Core Laboratory, Springfield, IL, US; 3. Clinical Events Committee and Data Safety Monitoring services provided by HCRI, Boston, MA, US* Sponsored by Medtronic plc
Robust Level 1 Evidence
• Prospective, multicenter EU and US, randomized (2:1), single-blinded trial
• 331 patients enrolled: • IN.PACT DCB (n = 220) vs. PTA (n = 111)
Rigorous and Unbiased
• Independent and blinded Duplex Ultrasound Core Lab,1 Angiographic Core Lab,2 and Clinical Events Committee3
• Independent Safety Monitoring Board
• External monitoring with 100% source data verification
Durability of Outcomes
• Subjects followed up to 5 years
IN.PACT SFA I150 subjects enrolled at 13 EU
sites Sep 2010-Apr 2011
IN.PACT SFA II181 subjects enrolled at 44 US
sites Apr 2012-Jan 2013
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IN.PACT SFA Trial
IN.PACT SFA I150 subjects enrolled at 13 EU sites
Sep 2010-Apr 2011
IN.PACT SFA II181 subjects enrolled at 44 US sites Apr
2012-Jan 2013
M. Brodmann, Graz, Austria G. Sorropago, Mercogliano, Italy
G. Tepe, Rosenheim, Germany P. Peeters, Bonheiden, Belgium
T. Zeller, Bad Krozingen, Germany F. Vermassen, Gent, Belgium
D. Scheinert, Leipzig, Germany C. Trani, Rome, Italy
A. Micari, Palermo, Italy M. Bosiers, Dendermonde, Belgium
I. Baumgartner, Bern, Switzerland J. Van den Berg, Lugano, Switzerland
S. Sixt, Hamburg, Germany
P. Krishnan, New York, NY, USA C. Walker, Houma, LA, USA
C. Metzger, Kingsport, TN, USA N. Strickman, Houston, TX, USA
A. Jain, Fremont, CA, USA R. Fairman, Philadelphia, PA, USA
R. Sachar, Raleigh, NC, USA S. Laster, Kansas City, MO, USA
N. Farhat, Elyria, OH, USA W. Gray, New York, NY, USA
L. Garcia, Boston, MA, USA V. Ramaiah, Phoenix, AZ, USA
R. Malhotra, Glendale, AZ, USA P. Alden, Minneapolis, MN, USA
S. Germanwala, Longview, TX, USA C. Stinis, La Jolla, CA, USA
A. Pershad, Phoenix, AZ, USA R. Dave, Camp Hill, PA, USA
B. Bigelow, Indianapolis, IN, USA R. Gallino, Washington, DC, USA
J. Zidar, Raleigh, NC, USA G. Ansel, Columbus, OH, USA
S. Ahanchi, Norfolk, VA, USA M. Schermerhorn, Boston, MA, USA
R. Feldman, Ocala, FL, USA M. Hunter, Cincinnati, OH, USA
R. Kovach, Brown Mills, NJ, USA M. Dake, Stanford, CA, USA
M. Goodwin, Naperville, IL, USA J. Benenati, Miami, FL, USA
L. Marone, Pittsburgh, PA, USA P. Schneider, Honolulu, HI, USA
M. Shishehbor, Cleveland, OH, USA R. Serry, Poway, CA, USA
D. Chew, Des Moines, IA, USA J. Angle, Charlottesville, VA, USA
P. Soukas, Providence, RI, USA K. Gupta, Kansas City, KS, USA
M. Garcia, Newark, DE, USA P. Jones, Chicago, IL, USA
M. Mewissen, Milwaukee, WI, USA G. Petrossian, Roslyn, NY, USA
R. Brown, Waco, TX, USA A. Patel, Morristown, NJ, USA
1. Tepe G. et al. Circ 2015;131:495-5022. Laird J.R. et al. JACC 2015;66:2329-23383. Schneider P. et al. Circ-CI 2018;11:1-8 5
• MAEs (including all individual components of the primary endpoints and key secondary endpoints) are adjudicated by the blinded CEC through 5 years
• Restenosis is assessed by the blinded Duplex and Angiographic Core Labs through the 3-year follow-up visits
† Conducted via Telephone Interview
5 Year Follow-up Assessment†
• Clinically-driven TLR: CD-TLR was adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any re-intervention at the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI
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IN.PACT SFA TrialBlinded, Independently Assessed Outcomes
IN.PACT SFA TrialBaseline Characteristics
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IN.PACTn = 220 subjects
PTAn = 111 subjects
P-value
Age, Y ± SD 67.5 ± 9.5 68.0 ± 9.2 0.612
Male, % (n) 65.0% (143/220) 67.6% (75/111) 0.713
Diabetes, % (n) 40.5% (89/220) 48.6% (54/111) 0.161
Current Smoker, % (n) 38.6% (85/220) 36.0% (40/111) 0.719
Rutherford Class, % (n) 2345
37.7% (83/220)57.3% (126/220)
5.0% (11/220)0.0% (0/220)
37.8% (42/111)55.9% (62/111)
5.4% (6/111)0.9% (1/111)
0.898
Lesion Length (cm± SD) 8.94 ± 4.89 8.81 ± 5.12 0.815
Total Occlusions, % (n) 25.8% (57/221) 19.5% (22/113) 0.222
Calcification, % (n) 59.3% (131/221) 58.4% (66/113) 0.907
Severe Calcification, % (n) 8.1% (18/221) 6.2% (7/113) 0.662
Provisional Stenting, % (n) 7.3% (16/220) 12.6% (14/111) 0.110
IN.PACT SFA TrialFreedom from CD-TLR through 5 Years
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IN.PACT SFA TrialEffectiveness Outcomes through 5 Years
1. Clinically-driven TLR adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any re-intervention at the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI
2. Any TLR includes clinically-driven and incidental or duplex driven TLR
† Unless otherwise indicated, all tests were for superiority using the Fisher’s exact test for binary variables and t-test for continuous variables.
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IN.PACT DCB (N=220)
PTA(N=111)
P-value†
CD-TLR1 25.5% (47/184) 35.6% (37/104) 0.080
Any TLR2 26.6% (49/184) 37.5% (39/104) 0.063
Time to CD-TLR within 1800 Days (Min, Max days)
807.5 ± 433.9(1, 1701)
474.9 ± 484.3(1, 1705)
< 0.001
IN.PACT SFA TrialSafety Outcomes through 5 Years
1. Safety Composite Endpoint consists of: freedom from device/procedure related death to 30 days; freedom from target limb amputation within 60 months; and freedom from clinically-driven TVR within 60 months.
2. Composite of death, clinically-driven TVR, target limb major amputation, and thrombosis3. All deaths adjudicated by the CEC† P-values are based on Fisher’s exact test for superiority with significance level of 0.05
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IN.PACT DCB (N=220)
PTA(N=111)
P-value†
Primary Safety Composite1 70.7% (130/184) 59.6% (62/104) 0.068
Major Adverse Events2 42.9% (79/184) 48.1% (50/104) 0.459
All-cause Death 15.8% (29/184) 9.6% (10/104) 0.156
Device- or Procedure-related Death through 5 Years3
0 (0/184) 0 (0/104) --
CD-TVR 29.3% (54/184) 40.4% (42/104) 0.068
Major Target Limb Amputation
0.5% (1/184) 0.0% (0/104) 1.000
Thrombosis 2.2% (4/184) 4.8% (5/104) 0.292
IN.PACT SFA Trial: All-cause DeathNo Device or Procedure-related Deaths
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All-cause Death Through 5 Years CEC-Adjudicated
DCB(N=184)
PTA(N=104)
Device-related
Procedure-Related
Cardiac-related 3.3% (6) 1.0% (1) No No
Malignancy-related 2.7% (5) 3.9% (4) No No
Respiratory-related 1.6% (3) 0.0% (0) No No
Neurological-related 2.2% (4) 0.0% (0) No No
Hepatobiliary-related 0.5% (1) 0.0% (0) No No
Gastrointestinal-related
1.6% (3) 1.9% (2) No No
Renal-related 0.5% (1) 0.0% (0) No No
Infection-related 1.1% (2) 0.0% (0) No No
Other 0.5% (1) 1.9% (2) No No
Unknown 1.6% (3) 1.0% (1) No No
Categorized by system-class
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IN.PACT SFA Trial through 5 YearsNo Relationship between Paclitaxel Dose and
Mortality Rate
o = outlier ◊ = mean
IN.PACT SFA Trial Through the Years
1. Medtronic IFU M052624T001_Rev1H2. Schneider P. et al. Circ-CI 2018;11:1-8
14*p-value compares DCB to PTA
IN.PACT SFA Trial Through the Years
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1. Tepe G. et al. Circ 2015;131:495-5022. Laird J.R. et al. JACC 2015;66:2329-23383. Schneider P. et al. Circ-CI 2018;11:1-84. Schneider P. VIVA 2017 5. Laird J.R. VIVA 2018*p-value compares DCB to PTA
Summary• First independently adjudicated, blinded, randomized trial to demonstrate
superior effectiveness of a drug-coated balloon (DCB) through five years.
• This final report of the IN.PACT SFA Trial demonstrates long-term safety of
the IN.PACT™ Admiral™ DCB through 5 years
– No device- or procedure-related deaths through 5 years
– Low thrombosis rates through 5 years
– No relationship between paclitaxel dose among those who died versus
survived
• The IN.PACT SFA Trial demonstrates durable effectiveness of the IN.PACT™
Admiral™ DCB
• Results support DCB as a first line strategy for the treatment of
femoropopliteal disease
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Thank You
5 Year Results from the IN.PACT SFA Randomized Trial
John R. Laird, MD
Adventist Heart and Vascular Institute
St. Helena, CA
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