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
20
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
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