1. Division of Endovascular Interventions
Mount Sinai Hospital
New York
07/25/2018

2. Presents with 1 Block claudication with Left>>R
Case presentation
71 year old female
HTN, DM, dyslipidemia,CAD, Ex smoker, known PAD with mutilple PTA’s and R AKA
Presents with 1 Block claudication with Left>>R
Medications: ASA, plavix, Lipitor, Lisinopril, Imdur, Metoprolol
Hb- 10.0, INR- 1.0, Creatinine- 1.4,
ABI - Right – 0.77, Left 0.58

3. RUNOFF LLE

4. STRATEGY Right CFA access 7F,45 cm crossover sheath
Therapeutic anticoagulation- Angiomax
IVUS to rule out thrombus (Angioject vs Penumbera)
Embo shield Filter
Eximer Laser vs Jet Stream vs DA
Endograft vs DCB angioplasty vs Zilver PTX

5. FILTER ALGORITHM
Embolic Protection Device Algorithm CTO = chronic total occlusion; ISR = in-stent restenosis; LL = lesion length; PAD = peripheral artery disease.
Prakash Krishnan et al. JCIN 2017;10:

6. Design EXCITE ISR Trial
250 patients enrolled between June 2011 and February 2014 in 40 clinical sites in United States
DESIGN: Prospective, randomized, multi-center clinical evaluation of excimer laser atherectomy (ELA)
OBJECTIVE: To evaluate safety and efficacy of ELA with adjunctive PTA (ELA+PTA) versus PTA alone for treating femoropopliteal in-stent restenosis
PRINCIPAL INVESTIGATORS Eric J Dippel, MD Craig Walker, MD
7 lesions uncrossable
250 lesions crossable by guidewire
169 ELA + PTA
81 PTA
Primary Safety endpoint at 37 days (n=155)
Primary Safety endpoint at 37 days (n=73)
Primary Efficacy endpoint at 212 days (n=117)
Primary Efficacy endpoint at 212 days (n=56)

7. Primary Endpoints Primary Safety Endpoint
Major Adverse Events through 30 days:
Death
Unplanned Major Amputation
Target Lesion Revascularization (TLR)
Primary Efficacy Endpoint
Freedom from clinically driven TLR at 6 months
DUS binary restenosis
Return of clinical symptoms
Deteriorated ABI or Rutherford Classification

8. Procedural Success ELA+PTA n = 169 PTA n = 81 P Value Turbo Elite use
79.9 na
Distal protection
40.2
30.9
0.16
% Diameter Stenosis
23.9±9.3
25.1±10.9
0.24
Residual Stenosis >30%
4.7
13.6
0.02
Procedural Success
93.5
82.7
0.03

9. Procedural Complications
All events adjudicated by CEC
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10. Product-Limit Survival Estimates
Primary Patency
Product-Limit Survival Estimates
With number of subjects at risk
365
p < 0.005
Survival Probability
Days from Index Procedure

11. Product-Limit Survival Estimates
Freedom from TLR
Product-Limit Survival Estimates
With number of subjects at risk
365
p < 0.003
Survival Probability
Days from Index Procedure

12. ELA with PTA should be considered for femoropopliteal ISR
Conclusions
ELA with adjunctive PTA treatment of ISR is superior to PTA alone for the treatment of femoro- popliteal ISR:
Complicated lesions averaging 19 cm in length
Significantly higher procedural success rate (ELA 93.5% vs PTA alone 82.7%, P=0.02)
Significantly higher safety rate (freedom from MAE: ELA 94.2% vs. PTA alone 79.2%, P<0.001)
Significantly lower rate of TLR for ELA throughout study
ELA with PTA should be considered for femoropopliteal ISR

14. RELINE TRIAL

16. RELINE- 1 year outcome
Journal of Endovascular Therapy 2015;22:1–10

17. IN.PACT Global Study: ISR Imaging Cohort
Patient and Clinical Characteristics
Characteristic
IN.PACT™ Admiral™ DCB
(n=131 Subjects)
Age
67.8y ± 10.1
Male Gender
69.5% (91/131)
Diabetes
35.1% (46/131)
Insulin Dependent Diabetes
15.3% (20/131)
Hypertension
81.5% (106/130)
Hyperlipidemia
72.1% (93/129)
Current Smoker
35.9% (47/131)
Obesity (BMI ≥ 30 kg/m²)
17.6% (23/131)
Coronary Heart Disease
36.5% (46/126)
Carotid Artery Disease
19.8% (23/116)
Renal Insufficiency1
9.9% (11/111)
Previous Peripheral Revascularization
100.0% (131/131)
Concomitant BTK Disease
43.3% (55/127)
ABI
0.667 ± (124)
Rutherford Category
Baseline serum creatinine ≥1.5 mg/dL.
Brodmann M, et al JACC CI 2017

18. IN.PACT Global Study: ISR Imaging Cohort
Lesion Characteristics
Procedural Characteristics
Characteristic
IN.PACT DCB
(N=149 Lesions)
ISR
(149/149)
Lesion Length (cm)
17.17 ± 10.47
Total Occlusions
34.0% (48/141)
Calcification Severe Calcification*
59.1% (78/132)
8.3% (11/132)
RVD (mm)
5.222 ± 0.601
Diameter Stenosis (pre-treatment)
84.8% ± 14.9
Dissections None A-C D-F
69.1% (103/149)
26.2% (39/149)
4.7% (7/149)
Characteristic
IN.PACT DCB (N=131 Subjects)
Device Success1
99.6% (282/283)
Procedure Success2
99.2% (130/131)
Clinical Success3
98.5% (129/131)
Pre-dilatation
64.1% (84/131)
Post-dilatation
26.0% (34/131)
Provisional Stent
14.5% (19/131)
Device success defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst below the RBP.
Procedure success defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab (if core lab was not available then the site-reported estimate was used).
Clinical success defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
* Severe calcium definition used by study sites and core laboratory is bilateral calcium at the same location (also measured in sections), ≥ half of the total lesion length, ≥180◦ (both sides of the vessel at the same location). Dattilo, R; J Invasive Cardiol 2014;26(8):355360
Brodmann M, et al JACC CI 2017

19. IN.PACT Global Study: ISR Imaging Cohort Primary Patency1 through 1 Year
102
Primary patency at 12 months was high at 88.7% and consistent with the 12-month freedom from CD-TLR (92.9%). The 12-month primary patency and freedom from CD-TLR in the ISR Imaging
Freedom from core laboratory-assessed restenosis (duplex ultrasound PSVR ≤2.4) or clinically-driven target lesion revascularization through 12 months (adjudicated by a Clinical Events Committee).
Number at risk represents the number of evaluable subjects at the beginning of the 30-day window prior to each follow-up interval.
Brodmann M, et al JACC CI 2017

20. IN.PACT Global Study: ISR Imaging Cohort Freedom from Clinically-Driven TLR1 at 1 Year
Clinically-driven TLR adjudicated by an independent Clinical Events 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.
Number at risk represents the number of evaluable subjects at the beginning of the 30-day window prior to each follow-up interval.
Brodmann M, et al JACC CI 2017

21. IN.PACT Global Study: ISR Imaging Cohort Additional Outcomes
IN.PACT™ Admiral™ DCB (N=131 Subjects)
Clinically-Driven TLR1
7.3% (9/124)
Any TLR
8.1% (10/124)
Any TVR
9.7% (12/124)
Primary Safety Endpoint2
91.1% (113/124)
Major Adverse Events3
8.9% (11/124)
All-Cause Death
0.0% (0/124)
Major Target Limb Amputation
Thrombosis
0.8% (1/124)
Any re-intervention within the target lesion(s) due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Composite of 30-day freedom from device- and procedure-related mortality and 12-month freedom from major target limb amputation and clinically-driven TVR.
Major Adverse Events: Composite of death, major target limb amputation, clinically-driven TVR, and thrombosis.
Brodmann M, et al JACC CI 2017

22. IN.PACT Global Study: ISR Imaging Cohort Summary
Strong efficacy and safety in a complex lesion subset
ISR lesions averaging 17.2 ± 10.5 cm
12-mo primary patency rate of 88.7%
12-mo CD-TLR rate of 7.3%
Confirms the effectiveness of the IN.PACT™ Admiral™ DCB in the treatment of complex ISR lesions

23. DEBATE ISR- 1 year data

25. DEBATE ISR: 1 year outcome

26. DEBATE ISR- 36 months data showed catch up in the DEB group

27. Treatment of SFA ISR Zilver® PTX® Drug Eluting Stent
Zeller et al. JACC Cardiovasc Intervent 2013

28. Zilver PTX - Freedom from TLR (1 year outcome)

29. Zilver PTX – Primary Patency (1 year outcome)

30. Acknowledgements 1) Sardar Farhan 2) Sandeep Singla 3) Ray Lascano
4) Vishal Kapur
5) Kartik Gujja
3) Dr. Krishnan