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