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Circulatory System Devices Advisory Panel. LACI Review Introductions Outline of presentations Presentations. Introductions & History. Introductions. Chris Reiser PhD VP Technology & Clinical Research, Spectranetics John Laird MD , Washington Hospital Center LACI Principal Investigator

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circulatory system devices advisory panel
Circulatory System Devices Advisory Panel

LACI Review

  • Introductions
  • Outline of presentations
  • Presentations

Introductions & History

introductions
Introductions
  • Chris Reiser PhD
    • VP Technology & Clinical Research, Spectranetics
  • John Laird MD, Washington Hospital Center
    • LACI Principal Investigator
  • Bruce Gray DO, Greenville Memorial Hosp, SC
    • LACI Steering Committee, Investigator
  • Venkatesh Ramaiah MD FACS, Arizona Heart
    • staff surgeon and LACI PI

Introductions & History

outline of presentations
Outline of Presentations
  • Background and history
  • LACI Phase 2 results
  • Benefits of LACI
  • Why limb salvage is better than limb loss
  • Alternative treatment strategies

1 : medication 2 : primary amputation

3 : PTA 4 : bypass surgery

  • Summary of alternatives

Introductions & History

basic technology
Basic Technology
  • Excimer laser atherectomy (ELA):
    • XeCl excimer laser, 308 nm, pulsed at 40 pulses/second maximum
  • Delivered via a fiberoptic catheter
  • First approved by FDA in 1993 for use in coronary arteries
  • Similar but slightly different than LASIK

Introductions & History

quick comparison
ELA

308 nm

fiber delivery

catheters

arteries & veins

“cool” UV ablation

LASIK

193 nm

free-air propagation

work station

corneas

“cool” UV ablation

Quick Comparison

Introductions & History

cvx 300 laser system
CVX-300 Laser System
  • Gen 4 approved 1994?
  • Same system used for all our applications:
    • coronary atherectomy
    • pacing lead removal
    • peripheral atherectomy (EU only)
  • A few facts...

Introductions & History

excimer laser catheters
Excimer Laser Catheters
  • 4th generation since first FDA approval
  • Latest models are “legs-only” devices
  • All have same basic features and work the same way

Introductions & History

how ela works
How ELA Works...

Introductions & History

how ela works9
How ELA Works...

Introductions & History

how ela works10
How ELA Works...

Introductions & History

coronary indications
Coronary Indications
  • Long, diffuse lesions
  • Total occlusions crossable with a wire
  • Moderately calcified lesions
  • Ostial lesions
  • Balloon angioplasty failures
  • Vein grafts
  • In-stent restenosis prior to brachytherapy

Introductions & History

ela experience in the legs
ELA Experience in the Legs
  • Initial IDE work in the USA - early ‘90s
  • Commercial experience in EU since ‘95?
  • Anecdotal single-site experiences
  • LACI Phase 1
  • LACI Phase 2

Introductions & History

slide13

Laser Angioplasty for Critical Limb Ischemia

Results of the LACI Phase 2 Registry

LACI 2 Results

slide14

Study Design

  • Prospective, multi-center study
  • Patients with CLI
    • Rutherford Category 4-6
    • poor surgical candidates
  • Treatment: ELA of SFA, popliteal and/or infrapopliteal arteries, with adjunctive PTA and optional stenting
  • Primary Efficacy Endpoint: limb salvage at 6 mo.
    • freedom from amputation at or above the ankle
  • Primary Safety Endpoint: death at 6 mo.

LACI 2 Results

slide15

Study Design

  • Included catheters:
    • 2.2 - 2.5mm Spectranetics peripheral laser catheters
    • any Spectranetics coronary laser catheter
  • Poor surgical candidates because:
    • poor or absent vessel for outflow anastamosis, or
    • absence of venous conduit, or
    • significant co-morbidity
  • Enrollment period: April ‘01 - April ’02
  • Enrollment: 145 patients, 155 limbs

LACI 2 Results

historical control group
Historical Control Group
  • Italian multicenter randomized study of Prostaglandin E1 in CLI patients
    • 771 in alprostadil group
    • 789 in control group
  • Control group received variety of therapies (bypass, endarterectomy, medication, and a few PTAs)
    • “the best you can do” for these patients
  • Ann Intern Med 1999; 130:412-421
  • Conforms to TASC definitions and GCP
slide17

Enrollment by Site

  • 145 patients at 14 sites

Arizona Heart 23

Hertzentrum Leipzig 24

Hertzentrum Bad Kroz. 22

Greenville Memorial 19

Manatee Hospital 10

Lankanau Memorial 8

Riverside Methodist 7

Glendale Memorial 7

St. Joseph’s Paterson 7

Univ. Frankfurt 6

Springhill Memorial 5

Washington HC 5

Ochsner Clinic 1

St. Luke’s Milwaukee 1

total patients 145

total legs 155

  • 36% of sites enrolled 68% of patients

LACI 2 Results

slide18

Patient Descriptors

LACIControlp

Mean age, years 72 ± 10 72 ± 10 ns

Men 53% 72% *

Risk factors

Smoking current 14% 25% *

Prior MI 23% 15% *

Prior stroke 21% 12% *

Diabetes mellitus 66% 39% *

Hypertension 83% 49% *

Dyslipidemia 56% 16% *

Obesity 35% 7% *

*significant

LACI 2 Results

slide19

Leg Descriptors

LACIControlp

Rutherford Category

4 27% 30% ns

5 or 6 72% 70% ns

Reasons for poor surgical candidacy

Absence of venous graft 32%

Poor/no distal vessel 68%

High surgical risk 46% 11% *

Only one reason 61%

Any two reasons 33%

All three reasons 6%

LACI 2 Results

slide20

Case Profile

  • 61 year old Hispanic woman
  • Diabetic for > 20 years
  • ESRD; hemodialysis for 1 year
  • Non-smoker
  • Multiple ischemic ulcers on both feet
  • Bilateral ELA on 14 Aug 01
  • Skin grafts during follow-up period
  • Investigator: Dr. Mitar Vranic at Arizona Heart

LACI 2 Results

slide21

Case Profile : Right Foot 1/4

Prior to treatment

LACI 2 Results

slide22

Case Profile : Right Foot 2/4

  • 2.2 mm laser
  • 3.0 mm balloon
  • no stent
  • popliteal also treated

LACI 2 Results

slide23

Case Profile : Right Foot 3/4

3 months post treatment

LACI 2 Results

slide24

Case Profile : Right Foot 4/4

6 months post treatment

LACI 2 Results

slide25

Case Profile : Left Foot

3 months

baseline

laser

balloon

no stent

6 months

LACI 2 Results

case profile
Case Profile
  • 45 year old female
  • Diabetes mellitus, morbid obesity
  • Distal popliteal occlusion, tibial disease
  • Painful, ischemic 2nd toe

LACI 2 Results

slide29

SITE 009-WHC

PAT 005

6 MOS

LACI 2 Results

vascular lesion locations
Vascular Lesion Locations

45%

40%

35%

30%

25%

% of Identified Lesions

20%

15%

10%

5%

0%

SFA

popliteal

infrapopliteal

other

LACI 2 Results

lesion types
Lesion Types

Mean # of treated lesions/pt: 2.7  1.4 (1-7)

80%

70%

60%

50%

% of Limbs

40%

30%

20%

10%

0%

stenoses

occlusions

stenoses and

occlusions

LACI 2 Results

tasc types
TASC Types

LACI 2 Results

laci procedure results
LACI Procedure Results

Guidewire crossing success 92%

Laser treatment delivered 99%

Adjunctive balloon 96%

Stent Placement 45%

Procedure Success 85%

<50% residual stenosis at final

Straight line flow to foot established 89%

Hospital stay (days): mean 3.0

median 1.0

LACI 2 Results

angiographic results visual assessment
Angiographic ResultsVisual assessment
  • %DS
  • LocationBaselinePost-laserFinal
  • SFA 91% 56% 16%
  • Popliteal 94% 53% 14%
  • Infrapopliteal 92% 53% 24%
    • Laser provided about half of the net luminal gain
    • Stenting was performed preferentially in larger vessels
    • Below the knee, final %DS was slightly higher

LACI 2 Results

control treatments
Control Treatments

Bypass or endarterectomy 35%

Angioplasty 5%

Thrombectomy 3%

Conservative therapies 57%

  • analgesics, vasoactive, antithrombotic, oxygen therapy, etc.

LACI 2 Results

adjudicated saes
Adjudicated SAEs

LACI Control p

Death 10% 14% ns

Major amputation 6% 10% ns

Nonfatal MI or Stroke .7% 1.1% ns

Reintervention 17% 4% *

Hematoma w/ surgery .7% .8% ns

Acute limb ischemia .7% n/a

Perforation w/ surgery 0 n/a

Bypass 2.1% n/a

Endarterectomy .7% n/a

Total SAEs 38% 30% ns

LACI 2 Results

6 month results patients
6-Month Results: Patients

Total enrollment 145 patients

death 15

lost to follow-up 11

Reached 6-month follow-up 119

Major amputation in survivors 9

Patients with limb salvage 110

Intent-to-treat analysis 110/145 = 76%

Survival analysis 110/119 = 92%

LACI 2 Results

6 month results limbs
6-Month Results: Limbs

Total enrollment 155 limbs

death 17

lost to follow-up 11

Reached 6-month follow-up 127

Major amputation in survivors 9

Limbs salvaged 118

Intent-to-treat analysis 118/155 = 76%

Survival analysis 118/118 = 93%

LACI 2 Results

slide39

Main Endpoints at 6 Months

LACIControlp

n 145 673

Died 10% 14% ns

Survived with:

Limb salvage 76% 73% ns

Persistent CLI 30% 31% ns

Any SAE* 38% 30% ns

* Including reinterventions not originally termed SAE’s under protocol

LACI 2 Results

slide40

Ulcer Sizes per-ulcer basis

Most healing occurred in the first 3 months

LACI 2 Results

slide41

Functional Outcomes

Of surviving legs:

69% Improved

27% Stable

4% Declined

LACI 2 Results

predictors of events
Predictors of Events
  • Major Amputationp
  • Category 6 .03
  • Previous minor amputation .05
  • Death
  • Age .03
  • by Cox proportional hazards modeling

LACI 2 Results

stenting
Stenting

Stented Not Stented

n=70n=85 p

Procedure Success 93% 79% .01

Straight-line flow 96% 84% .02

Limb Salvage 83% 71% .09

p-values by Fisher’s Exact

  • Stents improved acute results
  • Stents did not significantly affect limb salvage
  • Sample size is small (low statistical power)

LACI 2 Results

slide44

LACI Phase 2 Summary

  • Treatment of complex disease – multiple stenoses and occlusions
  • High risk patient population – poor candidates for surgical revascularization
  • High procedural success with few in-hospital SAE’s and short hospital stay
  • Excellent limb salvage rate despite this high-risk patient cohort

LACI 2 Results

slide45

LACI Phase 2 Summary

  • Outcomes met all hypotheses in the protocol
  • Statistics meet the benchmarks of safety and effectiveness

LACI 2 Results

clinical benefit of laci
Clinical Benefit of LACI
  • The LACI treatment strategy salvaged limbs...
    • Efficacy endpoint equaled “the best” benchmarks in the literature
  • …without affecting patient’s chances of survival...
    • Safety endpoint equaled “the best”
  • …or significantly increasing patients’ risk of serious adverse events.

Benefits

clinical benefit of laci47
Clinical Benefit of LACI
  • LACI is an intravascular intervention
    • avoids perioperative risks of surgery
    • shortens initial hospital stay
    • does not jeopardize future surgical options and may create new surgical options
  • LACI Phase 2 results were achieved with virtually no surgery

Benefits

clinical benefit of laci48
Clinical Benefit of LACI
  • The LACI strategy is applicable to a wide range of vascular disease states
    • not limited to lesions amenable to PTA
    • LACI Phase 2 enrolled essentially “all comers”
    • useful in patients with no other options for limb salvage
  • LACI results are predictable
    • high rate of procedure success

Benefits

technical benefit
Technical Benefit
  • ELA reduces a complex lesion pattern into something that balloons and (optional) stents can handle...

Benefits

progressive simplification

Normal

Post Laser

3mm Balloon

Final

Baseline

Progressive Simplification

Benefits

other advantages
Other Advantages
  • ELA technology is mature
  • ELA skills are based on standard interventional technique
  • ELA uses “cool” UV laser ablation

Benefits

limb salvage vs limb loss
Limb Salvage vs. Limb Loss
  • Is limb salvage always the best goal?

Or, stated another way:

  • What patient groups benefit from limb salvage?
  • What patients are better served by primary amputation?

Benefits of Limb Salvage

clinical outcomes
Clinical Outcomes

In Class C patients*

revascularizationamputation

operative mortality 6% 16%

hospital stay, days 14 31

regained ambulation 72% 44%

3-year survival 76% 29%

* Goldman score >9 or ASA class IV or V. Surgery 1988; 104:667-672

  • Promulgated “an aggressive approach to lower-extremity vascular reconstruction, irrespective of medical status”

Benefits of Limb Salvage

quality of life
Quality of Life
  • Comparing revascularized patients to primary amputees:
    • Revascularization had significantly lower depression, lower impairment of social function, greater mobility
    • QOL maintained after reintervention
    • QOL similar between primary amputation and amputation after failed revascularization
  • QOL always higher in limb salvage

Eur J Vasc Surg 1995; 9:310-313

Benefits of Limb Salvage

elderly patients
Elderly Patients
  • In patients >80 years

revascularizationamputation

survival 44% @ 5 yrs 28% @ 4 yrs

maintained

residential status 88% 65%

  • Elderly patients fare better with salvaged limbs

J Vasc Surg 1998; 28:215-225

Benefits of Limb Salvage

tasc recommendation 103
TASC Recommendation 103
  • Primary amputation for CLI is indicated:
    • Unreconstructable occlusive arterial disease
    • Necrosis of significant areas of weight-bearing portions of the foot
    • Fixed unremediable flexion contracture of the leg
    • Terminal illness, limited life expectancy
  • In how many patients does this apply?

Benefits of Limb Salvage

delphi consensus study
Delphi Consensus Study
  • Physicians were presented with 596 hypothetical CLI patient scenarios
  • Surgeons and radiologists indicated primary amputation in 9-10%

General consensus:

  • Vast majority should be revascularized
  • Primary amputation should be reserved for the most hopeless cases

Eur J Vasc Surg 2002; 24:411-416

Benefits of Limb Salvage

medication for cli
Medication for CLI
  • In the absence of LACI, patients at high risk of surgical mortality would receive medication and bed rest
  • TASC recommends only prostanoids, and then only when
    • revascularization has failed or is impossible
    • alternative is amputation
  • How would this subset of patients fare?

Alternative Therapy: Medication

recent reports
Recent Reports
  • Selected reports of medication for treatment of CLI
    • published in last 10 years
    • at least 100 CLI patients
    • poor surgical candidates
    • follow-up to at least 6 months
  • Compared to a subset of LACI patients who were at high risk of surgical mortality (ASA Class 4)

Alternative Therapy: Medication

literature comparisons
Literature Comparisons

Alternative Therapy: Medication

summary
Summary
  • Outlook for conservatively-treated CLI is dismal
    • 37% amputation in 6 months
    • high incidence of adverse events
  • LACI provided greater limb salvage, fewer SAEs, and shorter hospital stays

Alternative Therapy: Medication

why not randomize vs meds
Why not randomize vs. Meds?
  • Randomizing against a treatment plan that promises 37% major amputation at 6 months has ethical issues

Alternative Therapy: Medication

amputation for cli
Amputation for CLI
  • It might be proposed that patients who are not at a high risk of surgical mortality may better benefit from primary amputation.
  • Is this true for all CLI patients who are not at a high risk of surgical mortality?
  • How would this subset of patients fare?

Alternative Therapy: Amputation

recent reports64
Recent Reports
  • Selected reports of amputation for treatment of CLI
    • at least 100 CLI patients
    • follow-up statistics for comparisons
  • Compared to a subset of LACI patients who were not at high risk of surgical mortality (not ASA Class 4)

Alternative Therapy: Amputation

literature comparisons 1 2
Literature Comparisons 1/2

Alternative Therapy: Amputation

literature comparisons 2 2
Literature Comparisons 2/2

Alternative Therapy: Amputation

summary67
Summary
  • Patients receiving primary amputation are at risk for:
    • perioperative mortality
    • long hospital stay
    • high incidence of secondary amputation,

BKA AKA

  • LACI provided limb salvage with shorter hospital stays and decreased perioperative and post-operative mortality

Alternative Therapy: Amputation

why not randomize vs amp
Why not randomize vs. Amp?
  • Randomizing against a treatment plan that promises 100% major amputation with a high death rate, both perioperative and long term, has ethical issues

Alternative Therapy: Amputation

bypass for cli
Bypass for CLI
  • Bypass surgery is the “gold standard” for treatment of CLI.
    • Outcomes after bypass could be used as a possible benchmark for safety and efficacy
  • LACI patients were poor surgical candidates
    • Bypass was not a treatment option
  • How do LACI outcomes compare with the “gold standard”?

Alternative Therapy: Bypass

recent reports70
Recent Reports
  • Selected reports of bypass for treatment of CLI
    • patients treated with current bypass standards (treatment period 1987 - 2000)
    • autogenous vein grafts
    • infrainguinal revascularization
  • Compared to all LACI patients

Alternative Therapy: Bypass

literature comparisons 1 271
Literature Comparisons 1/2

Alternative Therapy: Bypass

literature comparisons 2 272
Literature Comparisons 2/2

Alternative Therapy: Bypass

summary73
Summary
  • Patients receiving bypass are at risk for early in-hospital complications including:
    • reintervention (graft revision or early re-operation)
    • death at 30 days
  • LACI provided limb salvage with very little need of bypass for patients who were poor surgical candidates

Alternative Therapy: Bypass

why not randomize vs bypass
Why not randomize vs. Bypass?
  • LACI patients were poor surgical candidates
    • high risk of surgical mortality, and/or
    • lack of distal anastomosis site, and/or
    • lack of venous conduit for bypass

Alternative Therapy: Bypass

pta for cli
PTA for CLI
  • Literature reports several single-center experiences since early ‘80s
  • Results were variable
    • patient selection criteria differed site-to-site
    • pre-selected disease patterns
    • adjunctive use or other treatments (atherectomy, thrombectomy, stents, etc) often not reported
    • follow-up intervals varied widely
  • No trials of PTA vs. anything in the past 15 years

Alternative Therapy: PTA

current consensus
Current Consensus
  • TASC document recommends PTA for CLI only in simple lesions:
    • Type A: single stenoses <1 cm
  • TASC does not recommend PTA in:
    • Type B: multiple short stenoses
    • Type C: long stenoses; short occlusions
    • Type D: occlusions >2cm; diffuse disease
      • surgery is recommended for Type D

Alternative Therapy: PTA

tasc types in laci
TASC Types in LACI

TASC Lesion TypeLACI legs n=155

A : short stenoses 3 (2%)

B : multiple short lesions 13 (8%)

C : complex patterns 44 (28%)

D : long diffuse disease 93 (60%)

insufficient data in 2/155 cases

Alternative Therapy: PTA

recent reports of pta in cli
Recent Reports of PTA in CLI
  • Selected recent articles
    • 8 years old
    • 50 patients
    • follow-up 6 months
    • CLI in 90% of patients
  • Inclusive of modern balloons, stents, anticoagulants, closure devices

Alternative Therapy: PTA

literature comparisons 1 279
Literature Comparisons 1/2

*30 day ‡6 months †1 year

Alternative Therapy: PTA

literature comparisons 2 280
Literature Comparisons 2/2

‡6 months †1 year ª5 year, initial successes only

Alternative Therapy: PTA

summary81
Summary
  • Literature reports patients pre-selected for PTA, not “all comers”
  • Some articles report on initial successes only
  • If the index procedure is successful, results may be comparable to LACI

Alternative Therapy: PTA

summary82
Summary
  • Compared to these articles, LACI had
    • lower incidence of bypass
    • fewer major amputations
    • similar rate of reintervention
    • similar rate of death
    • more complex disease
    • more fragile patient set
  • LACI outcomes equaled “the best” despite possible bias in the LACI population

Alternative Therapy: PTA

why not randomize vs pta
Why not randomize vs. PTA?
  • PTA is not recommended for all disease patterns in CLI (see TASC)
  • Evidence that PTA can be successful in CLI/poor surgical candidates is lacking; question of ethics in the control group
  • No study has made PTA the “gold standard”

Alternative Therapy: PTA

study design
Study Design
  • Randomized studies are easier to interpret than other controlled designs
  • Could LACI have been randomized?
  • Is there one control-group therapy that
    • is the standard of care,
    • is indicated for LACI patients, and
    • avoids the ethical issue of substandard care in the control group?

Why not randomize?

candidate control therapies
Candidate Control Therapies
  • Medication (conservative therapy)
  • Primary amputation
  • PTA + optional stents
  • Bypass surgery

Why not randomize?

why not randomize vs bypass86
Why not randomize vs. Bypass?
  • LACI patients were poor surgical candidates
  • Perioperative death is 1-10% higher for bypass than for LACI

Why not randomize?

why not randomize vs amp87
Why not randomize vs. Amp?
  • Patients receiving primary amputation are at risk for:
    • perioperative mortality
    • long hospital stay
    • high incidence of secondary amputation,

BKA AKA

  • Randomizing against a treatment plan that promises 100% major amputation with a high death rate, both perioperative and long term, has ethical issues

Why not randomize?

why not randomize vs meds88
Why not randomize vs. Meds?
  • Outlook for conservatively-treated CLI is dismal
    • 37% amputation in 6 months
    • high incidence of adverse events
  • LACI provided greater limb salvage, fewer SAEs, and shorter hospital stays
  • Randomizing against a treatment plan that promises 37% major amputation at 6 months has ethical issues

Why not randomize?

pta summary
PTA Summary
  • Literature reports patients pre-selected for PTA, not “all comers”
  • Some articles report on initial successes only
  • There is no definitive study making PTA the standard in CLI
    • We lack statistics needed to design a study using PTA as control
    • Would an IRB allow a non-standard control?

Why not randomize?

tasc types in laci90
TASC Types in LACI

TASC Lesion TypeLACI legs

A : short stenoses 2%

B : multiple short lesions 8%

C : complex patterns 28%

D : long diffuse disease 60%

TASC says:

PTA

Surgery

Why not randomize?

why not randomize vs pta91
Why not randomize vs. PTA?
  • PTA is not recommended for all disease patterns in CLI (see TASC)
  • Evidence that PTA can be successful in CLI/poor surgical candidates is lacking
  • Question of ethics in a PTA control group

Why not randomize?

randomization summary
Randomization Summary
  • No one therapy is appropriate, ethical, and standard-of-care for this population
  • Randomization would be unworkable

What does that leave?

  • Self-controlled study designs
  • Historical controls

Why not randomize?

best case historical control
Best-Case Historical Control
  • Exact match in patient characteristics
  • Huge enrollment
  • Full statistics, excellent follow-up
  • Treatment plan defines “standard”
    • in this case, a mixed set of modalities that uses best-case therapy for each patient
  • Conforms to TASC definitions

Why not randomize?

icai study
ICAI Study
  • Italian multicenter randomized study of Prostaglandin E1 in CLI patients
    • 771 in alprostadil group
    • 789 in control group
  • Control group received variety of therapies (bypass, endarterectomy, medication, and a few PTAs)
    • “the best you can do” for these patients
  • Ann Intern Med 1999; 130:412-421
  • Conforms to TASC definitions and GCP

Why not randomize?

icai study differences
ICAI Study: Differences
  • ICAI differs from LACI slightly
  • ICAI enrolled CLI patients regardless of candidacy for surgery
    • 35% of ICAI patients received surgery as their primary treatment option
    • LACI enrolled only poor surgical candidates
  • ICAI treatment plan is not an alternative for LACI patients

Why not randomize?

icai study implications
ICAI Study: Implications
  • ICAI treatment plan is not a fall-back plan for LACI patients
    • LACI population is not eligible for the same treatments, and hence may not enjoy the same outcomes as ICAI patients
  • ICAI statistics represent the benchmark for “the best you can do”
  • If ICAI statistics are safe and effective, then a treatment plan with equal statistics must also be safe and effective

Why not randomize?

implications for laci
Implications for LACI
  • ICAI sets the benchmark as high as possible
    • “the best you can do”
    • including surgery in 35% of patients
  • We chose the highest benchmark we could find against which to measure LACI
  • The control statistics are benchmarks, not a true measure of alternatives available to the LACI population

Why not randomize?