ReIntervention for Claudication: Is This Effective, or a Slippery - - PDF document

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ReIntervention for Claudication: Is This Effective, or a Slippery - - PDF document

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4/17/2018 ReIntervention for Claudication: Is This Effective, or a Slippery Slope? Patrick Geraghty, MD, FACS, RPVI Professor of Surgery and Radiology Conflicts Cook Medical trial PI Bard/Lutonix trial PI, consulting Boston

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4/17/2018 1

Re‐Intervention for Claudication:

Is This Effective, or a Slippery Slope?

Patrick Geraghty, MD, FACS, RPVI Professor of Surgery and Radiology

Conflicts

  • Cook Medical

trial PI

  • Bard/Lutonix

trial PI, consulting

  • Boston Scientific

trial PI, consulting

  • Intact Vascular

trial PI

  • Pulse Therapeutics

stock holder

  • Zimmer Biomet

consulting

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SLIDE 2

4/17/2018 2

PAD: Patterns of Presentation

  • Asymptomatic PAD
  • Claudication
  • Chronic Limb‐Threatening Ischemia (CLTI)

Reintervention is Good for the Soul

  • Gives you a chance to appreciate how foolish

you were for stenting the SFA in a ½ mile claudicant

  • After your bout of buyer’s remorse‐ because

you bought this one‐ take stock of your

  • ptions
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4/17/2018 3

Options, options…

  • You’re now at Robert Frost’s fork in the woods; what

factors dictate your choice?

  • Severity of secondary presentation
  • Stenosis versus occlusion
  • Smoking status
  • Artery diameter
  • ISR pattern
  • Runoff quality
  • Availability of good venous conduit
  • Surgical candidacy

What Parameters Matter?

  • PSV?
  • PSV ratios?
  • Recurrent claudication?
  • “IDE study failures” with PSVRs of 2.0‐2.5

carry a very low risk of near term thrombosis

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4/17/2018 4

Biology is the Culprit

  • Primary literature focus to date: diffuse in‐

stent restenosis secondary to intimal hyperplasia (IH)

  • Reintervention through stent can be

technically difficult, particularly if one is employing debulking strategies

Restoration + Prevention

LUMEN RESTORATION: ‐ PTA ‐Nitinol ‐DES ‐DCB ‐Atherectomy ‐Laser ‐Covered Stent Biologic Inhibition

  • f Intimal

Hyperplasia Extravascular Infusion Luminal Depot (DCB, DES) Mechanical Prevention of Luminal Ingrowth Covered Stent

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4/17/2018 5

SFA In‐Stent Restenosis

  • Seen in 20%‐ 40% of patients at one year post‐

intervention in recent trials

  • More common following treatment of long SFA
  • cclusions, small diameter SFA, diffuse disease
  • Increases at sites of stent fracture or stent
  • verlap; this has improved in the era of longer,

more flexible constructs

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4/17/2018 6

Current Options for SFA ISR

  • Plain Old Balloon Angioplasty (POBA)
  • Cutting/Scoring Balloon Angioplasty
  • Laser/Atherectomy
  • Covered Stent
  • Drug‐Eluting Stent
  • Drug‐Coated Balloon

POBA for Prior SFA Intervention

  • 222 patients with prior SFA intervention
  • 58 asymptomatic and 164 symptomatic
  • Reintervention PTA: 59% and bypass 41%
  • Bypass was used for more complex failures

(longer lesions, compromised runoff) but had better long term patency but higher initial morbidity

  • Davies et al, J Vasc Surg 2010
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4/17/2018 7

Stent Failures

  • 239 PTA + stent in SFA & popliteal
  • 69 failures
  • Initial TASC C or D classification predicted

higher risk of stent failure, failure with

  • cclusion, need for surgical revascularization,

and loss of outflow vessels

  • Gur et al, J Vasc Surg 2011

POBA for ISR

  • Tosaka et al, JACC 2012
  • 133 SFA ISR treated with POBA from 2000‐2009
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4/17/2018 8

POBA for ISR

  • Restenosis at 2 years after POBA for ISR:

– Class I: 49.9% – Class II: 53.3% – Class III: 84.8%

  • Recurrent occlusion seen in 64.6% of Class III

lesions treated with POBA

  • 11 Class III patients required bypass surgery
  • 1 required amputation

POBA‐ Freedom from 2° Restenosis

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4/17/2018 9

POBA for ISR‐ 2° Restenosis

Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168

POBA for ISR‐ Risk of Reocclusion

T

  • saka et al. JACC 2012;59:16-23

Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168

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4/17/2018 10

POBA for ISR‐ Control Arm Data

‐ RELINE Trial, Bosiers et al, JEVT 2015 ‐ FAIR Trial, Krankenberg et al., Circulation 2015

Cutting Balloon Similar to POBA for ISR

  • Dick et al, Radiology 2008; 248:297-302
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4/17/2018 11

Debulking Technology for ISR Atherectomy

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4/17/2018 12

Standalone Excisional Atherectomy for ISR

  • - 43 limbs with femoropopliteal ISR
  • - Mean lesion length 131 ± 111 mm
  • - Additional low pressure PTA in 59%
  • - Primary patency at 12 months: 54%
  • - Primary patency at 18 months: 49%
  • Zeller et al, JACC 2006

Excisional Atherectomy for ISR

  • Zeller et al, JACC 2006
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4/17/2018 13

Laser Atherectomy Laser Atherectomy for ISR‐ PATENT

  • Spectranetics Laser w/ Turbo Boost guide
  • 12.3 cm mean lesion length
  • 34% occlusions
  • Adjunctive PTA used in 88%
  • Distal embolization in 10% but no amputations
  • Primary Patency

– 6 MONTHS 64% – 12 MONTHS 38%

  • Schmidt et al, J Endovasc Ther 2014;21:52-60
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4/17/2018 14

Laser Atherectomy for ISR‐ PATENT

  • Schmidt et al, J Endovasc Ther 2014;21:52-60

Graph shows Freedom from TLR

Covered Stent

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4/17/2018 15

RELINE Trial – Viabahn vs PTA

75% Viabahn 28% PTA Freedom from Recurrent Restenosis (PSVR> 2.5)

‐ Bosiers et al, JEVT 2015

Covered Stent for ISR

STUDY # of patients LESION LENGTH cm PRIMARY PATENCY at 12 MONTHS Kazemi et al 2006 17 15 65% Ansel et al 2007 27 26 52% (18 months) Monahan et al J Vasc Surg 2011 24 n/a 62% Bosiers et al JEVT 2015 39 17 75%

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4/17/2018 16

Drug‐Coated Balloon (PTX)

Drug Coated Balloon for ISR Montevergine Registry

IN.PACT DEB Mean stent length 150mm Mean lesion length 83mm Primary patency: One year 92% Two year 70%

  • Stabile, JACC 2012
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4/17/2018 17

Femoral Artery In‐stent Restenosis Trial

  • POBA vs In.Pact DCB

– Lesion length 82 mm – CTO in 24‐33% – Stenting in 2‐7%

  • Six month primary

patency of 85% for DCB

  • Six month primary

patency of 55% for POBA

‐ Krankenberg et al., Circulation 2015

IN.PACT Global‐ ISR Cohort

  • 149 lesions, length 17 +/‐ 10 cm, 34% CTO
  • Brodmann et al, JACC- Cardiovasc Intervent, 2017
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4/17/2018 18

Drug‐Eluting Stent (PTX) ZILVER PTX Registry ISR Subset

  • 108 patients / 119 lesions with femoropopliteal

ISR at entry to single‐arm global ZPTX registry

  • Lesion length 133 ± 91.7 mm
  • Occlusion present in 31%
  • Procedural success achieved in 98.2%
  • Zeller, J Am Coll Cardiol Intv 2013; 6:274-81
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4/17/2018 19

ZPTX for ISR‐ Primary Patency

78.8% at 12 months

ZPTX for ISR‐ Freedom from TLR

60.8% at 24 months

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4/17/2018 20

Laser Atherectomy + DCB Laser + Paclitaxel DCB

  • 62 patients laser + DCB; 50 patients laser + PTA

– Lesion length 247 mm – Occlusion present in 74% – Bailout stents in 32% of L‐DCBs, 58% of L‐PTAs

  • 12 month freedom from re‐occlusion

– Laser + PTA 57% – Laser + POBA 87%

  • Kokkinidis, JEVT; 2018
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4/17/2018 21

SUMMARY of ISR OPTIONS

  • Tosaka class predicts outcomes
  • Leave stable Tosaka class 3 alone (CTOs)
  • Poor results with POBA
  • Cutting=POBA
  • Consider use of distal embolic protection!
  • Improved results with covered stent
  • Promising results with local drug delivery using

either DEB or DES, +/‐ atherectomy

QUESTIONS?