Nicolas W Shammas, MD, MS, FACC, FSCAINicolas W Shammas, MD, MS, FACC, FSCAIPresident and Research Director, President and Research Director,

Midwest Cardiovascular Research FoundationMidwest Cardiovascular Research FoundationAdjunct Clinical Associate Professor, Adjunct Clinical Associate Professor,

University of Iowa Hospitals and ClinicsUniversity of Iowa Hospitals and Clinics

Treatment Strategies for Peripheral In-Stent Restenosis

Presenter DisclosurePresenter Disclosure

Research and Educational GrantsResearch and Educational Grants from from CSI, Spectranetics, EV3, Abbott, Boston CSI, Spectranetics, EV3, Abbott, Boston Scientific, Edwards, Cordis and Volcano to Scientific, Edwards, Cordis and Volcano to the Midwest Cardiovascular Research the Midwest Cardiovascular Research Foundation Foundation

No equities or bonds in any No equities or bonds in any pharmaceutical or device companypharmaceutical or device company

ObjectivesObjectives

DefineDefine the problem of in-stent restenosis the problem of in-stent restenosis (ISR) in FP interventions (The Problem)(ISR) in FP interventions (The Problem)

DescribeDescribe procedural strategies in treating procedural strategies in treating FP ISR and their outcomes (Acute Rx)FP ISR and their outcomes (Acute Rx)

DiscussDiscuss various options in addressing various options in addressing recurrent restenosis in patients treated for recurrent restenosis in patients treated for FP ISR (Long term results)FP ISR (Long term results)

Current Device Application in Treating FP Current Device Application in Treating FP lesionslesions

0

10

20

30

40

50

60

S POBA A S + A

Percentage D

evice Use

Percentage D

evice Use

US Peripheral Device Market, 2012US Peripheral Device Market, 2012

S= Stent

POBA=Plain Old Balloon Angioplasty

A=Atherectomy

S+A= Stent + Atherectomy

S= Stent

POBA=Plain Old Balloon Angioplasty

A=Atherectomy

S+A= Stent + Atherectomy

Modified from Source: COVIDIENModified from Source: COVIDIEN

Cobra (Adjunctive Cryoplasty)

Cobra (Adjunctive Cryoplasty)

60% to 90%60% to 90%

50% to 70%50% to 70%

25% to 70%25% to 70%

One-Year TLR in Randomized SFA trialsOne-Year TLR in Randomized SFA trials

0

10

20

30

40

50

60

45 mm 63 mm 71 mm 132 mm

POBA

S

DES

Zilver PTX

Zilver PES

Schillinger

Absolute

FAST

LUMINEX

Percent TLR

Resilient

LifeStent

Mechanisms of ISRMechanisms of ISR Vascular injury (Barotrauma)Vascular injury (Barotrauma)

Endothelial loss (early response. Days)Endothelial loss (early response. Days)Platelet adherence, activation and aggregation…thrombus Platelet adherence, activation and aggregation…thrombus

formationformation Smooth muscle cell proliferation (intermediate response. Smooth muscle cell proliferation (intermediate response.

Weeks)Weeks) Extracellular matrix production (delayed response. Months)Extracellular matrix production (delayed response. Months)

Recoil and negative remodelingRecoil and negative remodeling has no significant role has no significant role in ISR (important mechanisms of restenosis in POBA)in ISR (important mechanisms of restenosis in POBA)

Clinical and angiographic risk factors:Clinical and angiographic risk factors: DM, CRI, lesion length, TASC D vs ABC, CRP, Poor runoff, DM, CRI, lesion length, TASC D vs ABC, CRP, Poor runoff,

CalcificationCalcification

Mechanisms of ISRMechanisms of ISROther possible mechanismsOther possible mechanisms

Stent fractureStent fractureStent Design and strut thicknessStent Design and strut thicknessStent overlapStent overlapBarotrauma of adjunctive angioplasty post Barotrauma of adjunctive angioplasty post

stentstentPoor stent expansion in calcified vesselsPoor stent expansion in calcified vesselsThrombosis (almost all total ISR occlusions are Thrombosis (almost all total ISR occlusions are

thrombotic-restenotic)thrombotic-restenotic)Slow flow in the distal vascular bedsSlow flow in the distal vascular bedsSmaller vessel sizeSmaller vessel size

Restenosis after FP StentingRestenosis after FP Stenting

Progressive problemProgressive problemRequires repeat revascularizationRequires repeat revascularizationRestenosis of long lesions are the “Achilles Restenosis of long lesions are the “Achilles

heel” of FP interventionsheel” of FP interventionsSeveral strategies to acutely treat FP Several strategies to acutely treat FP

restenosis but long term outcome is restenosis but long term outcome is relatively poor with reduced patency and relatively poor with reduced patency and high TLRhigh TLR

Strategies to treat FP ISRStrategies to treat FP ISR POBAPOBA Cutting BalloonCutting Balloon AtherectomyAtherectomy CryoplastyCryoplasty Radiation therapyRadiation therapy Drug coated balloonsDrug coated balloons RestentingRestenting

Bare metal stentBare metal stentDrug eluting stentsDrug eluting stentsCovered stentCovered stent

Tosaka A et al. J Am Coll Cardiol 2012;59:16-23

Classification of Restenosis After Femoropopliteal Stenting

multicenter, retrospective observational study133 restenotic lesions after FP artery stenting

classified by angiographic pattern: class I included focal lesions (≤50 mm in length), class II included diffuse lesions (>50 mm in length) class III included totally occluded ISR.

All patients were treated by POBA for at least 60 s

Restenosis was defined as >2.4 of the peak systolic velocity ratio>50% stenosis by angiography.

multicenter, retrospective observational study133 restenotic lesions after FP artery stenting

classified by angiographic pattern: class I included focal lesions (≤50 mm in length), class II included diffuse lesions (>50 mm in length) class III included totally occluded ISR.

All patients were treated by POBA for at least 60 s

Restenosis was defined as >2.4 of the peak systolic velocity ratio>50% stenosis by angiography.

Classification and Clinical Impact of Restenosis After Femoropopliteal Stenting

Tosaka A et al. J Am Coll Cardiol 2012;59:16-23

Class I pattern was found in 29% of the limbs,class II in 38%class III in 33%

Mean follow-up period was 24 ± 17 months.

All-cause death occurred in 14 patients bypass surgery was performed in 11 limbs

Rate of recurrent ISR at 2 years was84.8% in class III 53.3% in class II 49.9% in class I

Recurrent occlusion at 2 years was 64.6% in class III 18.9% in class II 15.9% in class I

Class I pattern was found in 29% of the limbs,class II in 38%class III in 33%

Mean follow-up period was 24 ± 17 months.

All-cause death occurred in 14 patients bypass surgery was performed in 11 limbs

Rate of recurrent ISR at 2 years was84.8% in class III 53.3% in class II 49.9% in class I

Recurrent occlusion at 2 years was 64.6% in class III 18.9% in class II 15.9% in class I

POBA vs Cutting BalloonsPOBA vs Cutting Balloons

Dick et al. Radiology 248;297-302, 2008Dick et al. Radiology 248;297-302, 2008

FP ISR >50% , single center, prospective, randomized, controlled trial, up to 20 cm Lesion length

CBA was performed in 22 patients

PCBA was used in 17 patients.

Average lesion length was 80 mm +/- 68

Acute stent thrombosis and stent fracture Were not included

Technical success was defined as aresidual stenosis of less than 30%

Restenosis defined as PSVR> 2.4

FP ISR >50% , single center, prospective, randomized, controlled trial, up to 20 cm Lesion length

CBA was performed in 22 patients

PCBA was used in 17 patients.

Average lesion length was 80 mm +/- 68

Acute stent thrombosis and stent fracture Were not included

Technical success was defined as aresidual stenosis of less than 30%

Restenosis defined as PSVR> 2.4

Cryoplasty for ISRCryoplasty for ISR

10 pts with FP ISR Twelve cryoplasty procedures All procedures were successful

Patency 50% at 6 monthsAll vessels occluded at 1 year

10 pts with FP ISR Twelve cryoplasty procedures All procedures were successful

Patency 50% at 6 monthsAll vessels occluded at 1 year

Cryoplasty is of no value in patients with restenosis in the iliofemoral segment with half the procedures failing within six months and all of them within the first year. Evidence to support the use of cryoplasty in the peripheral arterial restenotic lesions is lacking

Cryoplasty is of no value in patients with restenosis in the iliofemoral segment with half the procedures failing within six months and all of them within the first year. Evidence to support the use of cryoplasty in the peripheral arterial restenotic lesions is lacking

Karthik S. Eur J Vasc Endovasc Surg. 2007 Jan;33(1):40-3 Karthik S. Eur J Vasc Endovasc Surg. 2007 Jan;33(1):40-3

Patency after Brachytherapy for FP RestenosisPatency after Brachytherapy for FP Restenosis

79 patients treated with EVBT for 79 patients treated with EVBT for recurrent femoropopliteal lesionsrecurrent femoropopliteal lesions

Clinical follow-up at 1, 3, 6, and 12 Clinical follow-up at 1, 3, 6, and 12 months and annuallymonths and annually

clinical follow-up was 32.3+/-21.5 clinical follow-up was 32.3+/-21.5 months months

Clinical success rates at 1, 2, and Clinical success rates at 1, 2, and 3 years, respectively, were 84.3%, 3 years, respectively, were 84.3%, 82.1%, and 76.4% after BA versus 82.1%, and 76.4% after BA versus 82.4%, 69.8%, and 67.5% after 82.4%, 69.8%, and 67.5% after BA+EVBT (p=0.26 by log-rank)BA+EVBT (p=0.26 by log-rank)

Long term patency was not Long term patency was not different from POBA alone different from POBA alone

70.7

82.7

63.164.3

47.1

64.3

0

10

20

30

40

50

60

70

80

90

1 yr 2yr 3yr

POBA

POBA + EBVT

P=0.16P=0.16

Diehm et al. J Endovasc Ther. 2005 Dec;12(6):723-30. Diehm et al. J Endovasc Ther. 2005 Dec;12(6):723-30.

SilverHawk AtherectomySilverHawk Atherectomy

Plaque Excision System

Remove plaque by directional atherectomy

Tiny laser-drilled nosecone holes for tissue collection andRemoval

Plaque Excision System

Remove plaque by directional atherectomy

Tiny laser-drilled nosecone holes for tissue collection andRemoval

Intima-Media Thickness following Silverhawk Atherectomy vs PTA for Intima-Media Thickness following Silverhawk Atherectomy vs PTA for FP ISRFP ISR

0.1

0.178

0.145

0.206

0.121

0.177

0

0.05

0.1

0.15

0.2

0.25

2 mon 5 mon 6 mon

PTA

SA

mm

mm

P=0.001P=0.001 P=0.003

P=0.003

P=0.02P=0.02

Randomized, controlled, pilot trial

Total 19 patients

9 patients in the atherectomy device

10 patients in the PTA arm

Primary endpoint: Intima-media thickness within the treated segment

SA did not perform better than PTA

Randomized, controlled, pilot trial

Total 19 patients

9 patients in the atherectomy device

10 patients in the PTA arm

Primary endpoint: Intima-media thickness within the treated segment

SA did not perform better than PTA

Brodmann et al. Cardiovasc Intervent Radiol. 2013;36:69-74Brodmann et al. Cardiovasc Intervent Radiol. 2013;36:69-74

Patency of FP segments after Silverhawk atherectomy Patency of FP segments after Silverhawk atherectomy for ISR for ISR

86.2

68

25

0

10

20

30

40

50

60

70

80

90

3 mon 6 mon 12 mon

Patency

35 lesions in 33 patients

Primary endpoint : treatment success (<50% residual stenosis) and no complications.

Secondary endpoint : patency as assessed by duplex ultrasound

Mean lesion length 10.8 cm

Atherectomy with adjunctive PTA success 97%

Adjunctive stent implantation 11%

major complication was 18% (6/34), mainly due to distal embolization.

35 lesions in 33 patients

Primary endpoint : treatment success (<50% residual stenosis) and no complications.

Secondary endpoint : patency as assessed by duplex ultrasound

Mean lesion length 10.8 cm

Atherectomy with adjunctive PTA success 97%

Adjunctive stent implantation 11%

major complication was 18% (6/34), mainly due to distal embolization.

Trentmann J et al. J Cardiovasc Surg (Torino). 2010;51:551-60.Trentmann J et al. J Cardiovasc Surg (Torino). 2010;51:551-60.

Patency of FP segments after Silverhawk atherectomy Patency of FP segments after Silverhawk atherectomy for ISR for ISR

43 limbs with FP ISR43 limbs with FP ISR Mean lesion length Mean lesion length

13.1 cm13.1 cm Additional low Additional low

pressure balloon pressure balloon inflation in 59%inflation in 59%

Primary patency at 12 Primary patency at 12 months: 54%months: 54%

Primary patency at 18 Primary patency at 18 months: 49%months: 49%

54

48

45

46

47

48

49

50

51

52

53

54

12 mon 18 mon

SA for ISR

percent

percent

Zeller T et al. J Am Coll Cardiol. 2006;48:1573-8 Zeller T et al. J Am Coll Cardiol. 2006;48:1573-8

Target Vessel revascularization after SilverHawk atherectomy for Target Vessel revascularization after SilverHawk atherectomy for ISRISR

41 consecutive patients in a retrospective registry

Follow-up: mean of 331.63 days

Adjunctive balloon angioplasty 97.6%

Embolic filter protection (EFP) 56.1% of patients.

Distal embolization (DE) requiring treatment 7.3%Bailout stenting was 24.4%

Acute procedural success occurred in 100%

TLR 31.7% TVR 34.1%

41 consecutive patients in a retrospective registry

Follow-up: mean of 331.63 days

Adjunctive balloon angioplasty 97.6%

Embolic filter protection (EFP) 56.1% of patients.

Distal embolization (DE) requiring treatment 7.3%Bailout stenting was 24.4%

Acute procedural success occurred in 100%

TLR 31.7% TVR 34.1%

Shammas NW et al. Cardiovasc Revasc Med. 2012;13(4):224-7Shammas NW et al. Cardiovasc Revasc Med. 2012;13(4):224-7

Laser atherectomy for ISRLaser atherectomy for ISRMechanisms of ActionMechanisms of Action

PhotoablationPhotoablation

(1)(1) Photochemical Photochemical : disruption of cellular : disruption of cellular molecular bonds molecular bonds

(2)(2) PhotothermalPhotothermal: heat production with : heat production with steam vapor disruption of cell steam vapor disruption of cell membranes membranes

(3)(3) Photomechanical: Photomechanical: dissipates cellular dissipates cellular debrisdebris

Laser atherectomy of ISR of popliteal and AT

Laser atherectomy of ISR of popliteal and AT

Patency Among PATENT FP ISR Study Patients at 1 yearPatency Among PATENT FP ISR Study Patients at 1 year

60

37.8

0

10

20

30

40

50

60

6 mon 12 mon

Laser

90 patients at five centers in Germany

Laser atherectomy for FP ISR

A nonrandomized prospective registry

Average lesion length 10.9 cm

Procedural success rate of 98.8%

90 patients at five centers in Germany

Laser atherectomy for FP ISR

A nonrandomized prospective registry

Average lesion length 10.9 cm

Procedural success rate of 98.8%

Zeller T et al. Leipzig Interventional Course (LINC) 2013 Zeller T et al. Leipzig Interventional Course (LINC) 2013 P

ate

ncy

Pa

ten

cy

TLR Among PATENT FP ISR Study Patients at 1 yearTLR Among PATENT FP ISR Study Patients at 1 year

81% at 6 months 81% at 6 months

52% at 12 months 52% at 12 months

Zeller T et al. Leipzig Interventional Course (LINC) 2013 Zeller T et al. Leipzig Interventional Course (LINC) 2013

TLR of FP segments after Laser atherectomy for ISRTLR of FP segments after Laser atherectomy for ISR

40 consecutive patients

Followed for 1 year

Adjunctive balloon angioplasty 100%

Acute procedural success 92.5%Embolic filter protection was used in 57.5%Bailout stenting was 50.0%Macrodebris was noted in 65.2% of filters Distal embolization requiring treatment 2.5%

TLR 48.7%TVR 48.7%

40 consecutive patients

Followed for 1 year

Adjunctive balloon angioplasty 100%

Acute procedural success 92.5%Embolic filter protection was used in 57.5%Bailout stenting was 50.0%Macrodebris was noted in 65.2% of filters Distal embolization requiring treatment 2.5%

TLR 48.7%TVR 48.7%

Shammas NW et al. Cardiovasc Revasc Med. 2012;13:341-4Shammas NW et al. Cardiovasc Revasc Med. 2012;13:341-4

SA vs Laser for FP ISRSA vs Laser for FP ISR

Shammas NW et al. In print in JEVT, Dec 2013Shammas NW et al. In print in JEVT, Dec 2013

ELA was utilized more frequently than SA in

longer lesions 210.4±104 vs. 126.2±79.3subacute presentation 55% vs. 14.6%TASC D lesions angiographic thrombus 42.5% vs. 4.9%

Regression analysis confirmed that SA was a predictor of TLR at 1 year (odds ratio 2.679, 95% CI 1.015 to 7.073, p=0.047).

ELA was utilized more frequently than SA in

longer lesions 210.4±104 vs. 126.2±79.3subacute presentation 55% vs. 14.6%TASC D lesions angiographic thrombus 42.5% vs. 4.9%

Regression analysis confirmed that SA was a predictor of TLR at 1 year (odds ratio 2.679, 95% CI 1.015 to 7.073, p=0.047).

JetStream ISR: baseline, after Jetstream and after adjunctive balloon

JetStream ISR: baseline, after Jetstream and after adjunctive balloon

Patency of FP segments after Pathway atherectomy Patency of FP segments after Pathway atherectomy for ISRfor ISR

40 infrainguinal ISR lesions Treated with Pathway AtherPrimary patency 33% at 12 months 25% at 24 months

Pathway modified to JetstreamOngoing JetStream ISR registry

40 infrainguinal ISR lesions Treated with Pathway AtherPrimary patency 33% at 12 months 25% at 24 months

Pathway modified to JetstreamOngoing JetStream ISR registry

33

25

0

5

10

15

20

25

30

35

12 mon 24 mon

Patency

Percent

Percent

Beschorner U, et al. Vasa. 2013;42:127-133. Beschorner U, et al. Vasa. 2013;42:127-133.

Atherosclerotic Debris Following Atherosclerotic Debris Following Atherectomy of FP ISRAtherectomy of FP ISR

SilverHawk registry for FP ISR*Debris in 81.9% of filters;36.4% were macrodebris Distal embolization requiring treatment 7.3% (3 patients with EFP)

Laser registry for FP ISR **Macrodebris in 65.2% of filters. Distal embolization requiring treatment 2.5% (1 patient with no EFP)

* Cardiovasc Revasc Med. 2012;13(4):224-7** Cardiovasc Revasc Med. 2012;13:341-4

SilverHawk registry for FP ISR*Debris in 81.9% of filters;36.4% were macrodebris Distal embolization requiring treatment 7.3% (3 patients with EFP)

Laser registry for FP ISR **Macrodebris in 65.2% of filters. Distal embolization requiring treatment 2.5% (1 patient with no EFP)

* Cardiovasc Revasc Med. 2012;13(4):224-7** Cardiovasc Revasc Med. 2012;13:341-4

Atherectomy with Covered Stents for FP ISR: The Atherectomy with Covered Stents for FP ISR: The SALVAGE trialSALVAGE trial

Multicenter prospective registry involving 9 US centers

Excimer laser and the VIABAHN endoprosthesis 27 patients enrolled The mean lesion length was 20.7 ± 10.3 cmTASC (TASC I) C and D (81.4%)

Technical success 100% of cases

Primary patency at 12 months was 48%The 12-month TLR rate was 17.4%

Multicenter prospective registry involving 9 US centers

Excimer laser and the VIABAHN endoprosthesis 27 patients enrolled The mean lesion length was 20.7 ± 10.3 cmTASC (TASC I) C and D (81.4%)

Technical success 100% of cases

Primary patency at 12 months was 48%The 12-month TLR rate was 17.4%

48

0

5

10

15

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25

30

35

40

45

50

1 yr

Patency

Percentage

Percentage

Laird JR et al. Catheter Cardiovasc Interv. 2012 Nov 1;80(5):852-9 Laird JR et al. Catheter Cardiovasc Interv. 2012 Nov 1;80(5):852-9

Covered Stent for FP ISRCovered Stent for FP ISR

Retrospective analysis at a single center (n=39)Retrospective analysis at a single center (n=39)Patency: Duplex follow-up (ratio > 2.0) Patency: Duplex follow-up (ratio > 2.0) No exclusionsNo exclusionsPTA/Laser/Viabahn PTA/Laser/Viabahn Average follow up 18 mo Average follow up 18 mo Average lesion length = 27.1 cm (5-44) Average lesion length = 27.1 cm (5-44)

Patency Patency Primary 17/33 (52%) Primary 17/33 (52%) Assisted 23/33 (67%) Assisted 23/33 (67%) Secondary 27/33 (82%) Secondary 27/33 (82%)

Ansel G et al. TCT 2008Ansel G et al. TCT 2008

ZilverZilver® ® PTX™PTX™ ZilverZilver®®, self-expanding nitinol stent, self-expanding nitinol stent Coated with Paclitaxel Coated with Paclitaxel

No polymer or binderNo polymer or binder 3 µg/mm3 µg/mm22 dose density dose density

No randomized data in FP ISR. No randomized data in FP ISR. Observational Data from Zilver PTX registryObservational Data from Zilver PTX registry

Uncoated PTX™ Coated

Patency Among Zilver PTX FP ISR PatientsPatency Among Zilver PTX FP ISR Patients

119 ISR lesions in ZILVER-PTX single-arm prospective, multicenter, trial of 787 ptspaclitaxel-eluting nitinol stents

Mean lesion length was 133.0 mm 33.6% of lesions >150 mm long31.1% of lesions totally occluded Procedural success 98.2%

Primary patency 95.7% 6 months 78.8% at 1 year

Freedom from TLR 96.2% at 6 months81.0% at 1 year 60.8% at 2 years

119 ISR lesions in ZILVER-PTX single-arm prospective, multicenter, trial of 787 ptspaclitaxel-eluting nitinol stents

Mean lesion length was 133.0 mm 33.6% of lesions >150 mm long31.1% of lesions totally occluded Procedural success 98.2%

Primary patency 95.7% 6 months 78.8% at 1 year

Freedom from TLR 96.2% at 6 months81.0% at 1 year 60.8% at 2 years

Zilver PTX

No in-stent ledions

Zilver PTX

No in-stent ledions

Zilver PTX

In-stent ledions

Zilver PTX

In-stent ledions

87%87%

80%80%

Patency

Patency

Zeller T et al. J Am Coll Cardiol Intv. 2013;6:274-281 Zeller T et al. J Am Coll Cardiol Intv. 2013;6:274-281

DEB in Treating FP ISRDEB in Treating FP ISR39 consecutive patients PTA of SFA-ISR . CLI 20.5%. Diabetics 48.7%All patients underwent conventional SFA PTA Post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota)Bail out stenting 10.3%Lesion length: 8.3 cm. Stent length 15 cm DEB length 16 cm (cumulative)Follow up to 12 months.

Technical success 100%Procedural success 100% No in-hospital major adverse cardiac

Primary patency rate at 12 months was 92.1%

39 consecutive patients PTA of SFA-ISR . CLI 20.5%. Diabetics 48.7%All patients underwent conventional SFA PTA Post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota)Bail out stenting 10.3%Lesion length: 8.3 cm. Stent length 15 cm DEB length 16 cm (cumulative)Follow up to 12 months.

Technical success 100%Procedural success 100% No in-hospital major adverse cardiac

Primary patency rate at 12 months was 92.1%

0

10

20

30

40

50

60

70

80

90

100

1 year

1 year

Percen

tP

ercent

Stabile E et al. J Am Coll Cardiol. 2012 ;60:1739-42Stabile E et al. J Am Coll Cardiol. 2012 ;60:1739-42

DEB in Treating FP ISRDEB in Treating FP ISR

44 consecutive Diabetic patients PTA of SFA-ISR . CLI 64%Paclitaxel-eluting balloon (IN.PACT, Medtronic, Minneapolis, Minnesota)Follow up to 12 months.

Primary patency rate at 12 months was 90.5%TLR at 12 months 13.6%

44 consecutive Diabetic patients PTA of SFA-ISR . CLI 64%Paclitaxel-eluting balloon (IN.PACT, Medtronic, Minneapolis, Minnesota)Follow up to 12 months.

Primary patency rate at 12 months was 90.5%TLR at 12 months 13.6%

90.5

0

10

20

30

40

50

60

70

80

90

100

1 year

1 year

Percen

tP

ercent

F. Liistro. TCT poster 343, 2012 Miami F. Liistro. TCT poster 343, 2012 Miami

DEB after Directional Atherectomy for ISRDEB after Directional Atherectomy for ISR

Retrospective study89 lesions of consecutive patientsAdjunctive POBA n = 60 or DEB n = 29Lesions in- stent (DCB [n = 27] vs PTA [n = 36])

Patency at 1 year:DEB: 84.7% (70.9%-98.5%) POBA: 43.8% (30.5%-57.1%)

HR: 0.28 (0.12-0.66; P = .0036) for DEB

Retrospective study89 lesions of consecutive patientsAdjunctive POBA n = 60 or DEB n = 29Lesions in- stent (DCB [n = 27] vs PTA [n = 36])

Patency at 1 year:DEB: 84.7% (70.9%-98.5%) POBA: 43.8% (30.5%-57.1%)

HR: 0.28 (0.12-0.66; P = .0036) for DEB

Sixt et al. J Vasc Surg. 2013 Sep;58(3):682-6Sixt et al. J Vasc Surg. 2013 Sep;58(3):682-6

43.8

84.7

0

10

20

30

40

50

60

70

80

90

1 year

POBA

DEB

Patency (%

)P

atency (%)

P=0.036P=0.036

Pharmacological interventionsPharmacological interventions

No large randomized studiesNo large randomized studies

Possible benefit in smaller studiesPossible benefit in smaller studies

Systemic side effects/toxicitySystemic side effects/toxicity CilostazolCilostazol ProbucolProbucol Oral SirolimusOral Sirolimus

Unlikley that the answer to FP ISR will be with systemic drug therapy Unlikley that the answer to FP ISR will be with systemic drug therapy because of high concentration needed to achieve inhibition of because of high concentration needed to achieve inhibition of restenosisrestenosis

PhotoDynamic therapy is still highly experimental (Light + PhotoDynamic therapy is still highly experimental (Light + Aminolevulinic acid)Aminolevulinic acid)

Upcoming StudiesUpcoming Studies

DCB vs. Laser & DCB (PHOTOPAC). Primary DCB vs. Laser & DCB (PHOTOPAC). Primary endpoint: target lesion percent stenosis at endpoint: target lesion percent stenosis at 1 year by angiographic core lab1 year by angiographic core lab

RELINE: POBA vs. ViabahnRELINE: POBA vs. ViabahnEXCITE: POBA vs Laser EXCITE: POBA vs Laser POBA vs. DCB (FAIR, COPA CABANA, etc.) POBA vs. DCB (FAIR, COPA CABANA, etc.)

SummarySummary FP ISR remains a challenging problemFP ISR remains a challenging problem Acute procedural outcomes are generally Acute procedural outcomes are generally

successful with multiple modalities of treatment successful with multiple modalities of treatment but long term outcomes remain overall poor, but long term outcomes remain overall poor, particularly for long lesions and total occlusionsparticularly for long lesions and total occlusions

Atherectomy can reduce bail out stenting but has Atherectomy can reduce bail out stenting but has high rate of distal embolization. The long term high rate of distal embolization. The long term patency compared to POBA is unknown. SA is a patency compared to POBA is unknown. SA is a predictor of recurrent restenosis compared to predictor of recurrent restenosis compared to Laser at 1 year follow- upLaser at 1 year follow- up

Promising new technologies include DEB, DES with Promising new technologies include DEB, DES with or without atherectomy are on the horizonor without atherectomy are on the horizon

THANK YOUTHANK YOU