IN-STENT RESTENOSIS: WHAT
IS THE IMPACT OF
REINTERVENTION? WHAT IS
THE CHOICE OF THERAPY
COSTING YOU
Jeffrey Y. Wang MD
Horizon Vascular Specialists
Director of Vascular Research
Shady Grove Adventist Hospital
Disclosure
• Speaker name:
• Jeffrey Wang
• I have the following potential conflicts of interest to report:
• Consulting (Gore, Boston Scientific,CSI)
• Employment in industry
• Stockholder of a healthcare company
• Owner of a healthcare company
• Other(s)
• I do not have any potential conflict of interest
X
In-Stent Restenosis
• Vascular Intervention is palliative not curative
• If the patient lives long enough you will have to re-
intervene
• If you use stents….you will get In-stent restenosis
Re-intervention
• What to do?.....
• Balloon?
• Bare Metal Stent?
• “Doing the same thing over and over again and expecting
a different result”
• Atherectomy?
• Drugs?
• Covered Stent?
HPI
• 76 yo female with right calf ulceration and foot ulceration
• Diabetic, Smoker 30 pack years, HTN, High cholesterol
• Ulcers have been present for 3 months
• Had a previous intervention for ulceration 3yrs ago
HPI
• 63 yo male with rest pain of his right leg
• Smoker 40 pack years, HTN
• Pt was treated 5 years ago for similar symptoms
Comparing Multi-Center, Randomized
ISR Trials: Lesion Characteristics
FAIR Trial EXCITE ISR Trial RELINE Trial
IN.PACT
DCB
PTA Excimer Laser
Atherectomy
PTA GORE®
VIABAHN® Endoprosthesis
PTA
Mean
Lesion
Length
(mm)
82 82 196 193 173 190
% CTOs 24% 33% 31% 37% 23% 25%
Moderate-
Severe
Calcification
10%* 9%* 27% 9% 33% 25%
*RELINE Trial and EXCITE ISR Trial report Moderate-Severe Calcification,, while FAIR Trial
reports only “Heavy Calcium”. Dippel, EJ: TCT 2014; Krankenberg H; LINC 2015;
Bosiers M: JEVT 2015
Comparing Multi-Center, Randomized
ISR Trials:12-month Outcomes
FAIR Trial EXCITE ISR RELINE Trial
IN.PACT
DCB PTA Excimer
Laser
Atherectomy
PTA GORE®
VIABAHN®
Endoprosthesis
PTA
Primary
Patency at
12-months
70.5% 37.5% ~40% ~20% 75% 28%
Freedom
from TLR at
12-months
91% 53% ~47% ~28% 80% 40%
*RELINE Trial and EXCITE ISR Trial report Moderate-
Severe Calcification,, while FAIR Trial reports only “Heavy
Calcium”. Dippel, EJ: TCT 2014; Krankenberg H; LINC 2015;
Bosiers M: JEVT 2015
Cost Considerations in ISR
• Cost to prepare the patient for intervention
• Cost of the catheterization lab per hour
• Cost of recovery area per hour
• Cost of the catheters wires and adjuvant devices
• Cost of the actual treatment device
Cost of Therapy
• There is a real difference in cost of devices
• The device is only one cost of many
• Reduction of re-intervention over the life of the patient is
the true cost savings
• The difference in cost between treatment device is small
in comparison to the total cost of an additional
intervention
Conclusion
• No head to head direct comparison
• When looking at lesion length and patency
• Trend to favor Viabahn for complex ISR
• The treatment of a patient’s PAD is lifelong
• The cost of treatment is cumulative over that patients life
not each individual treatment intervetion
IN-STENT RESTENOSIS: WHAT
IS THE IMPACT OF
REINTERVENTION? WHAT IS
THE CHOICE OF THERAPY
COSTING YOU
Jeffrey Wang MD
Horizon Vascular Specialists