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Peripheral Arterial Disease SVS Clinical Research Priorities. Michael C. Stoner, MD East Carolina Heart Institute East Carolina University Department of Cardiovascular Sciences Brody School of Medicine. PAD Epidemiology. 8 – 12 million Americans 12 – 15\% of population over 65 years.

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peripheral arterial disease svs clinical research priorities

Peripheral Arterial DiseaseSVS Clinical Research Priorities

Michael C. Stoner, MD

East Carolina Heart Institute

East Carolina University

Department of Cardiovascular Sciences

Brody School of Medicine

pad epidemiology
PAD Epidemiology
  • 8 – 12 million Americans
    • 12 – 15% of population over 65 years

Allison JVS 2009.

Ciriqui Circulation 2005.

Selvin Circulation 2004.

Hirsch Vasc Med 208.

limb salvage cli pts
HI

LI

Limb Salvage (CLI pts)

P < 0.05

Durham JVS 2010.

pad clinical impact
PAD Clinical Impact
  • REACH registry – poor outcomes with concomitant cor and PAD
    • Many asymptomatic PAD cases, marker of atheroscleortic disease burden
  • Poorly understood societal impact
  • Claudication – <1% limb loss rate / year
  • CLI – 25%

Mahoney Circ CV Qual Outcomes 2010.

cost of pad
Cost of PAD
  • $7 – 8 billion – Medicare expenditure
  • $151 billion – Total US healthcare system
    • $14.3 billion – Inpatient CLI care
    • $10.2 billion – Inpatient PAD care

Hirsch Vasc Med 208.

pad technology
PAD Technology
  • Rapid expansion of under-studied devices
    • High-quality trials expensive and may lack external validity
    • Lateral diffusion of technology across specialties
    • Provider and institution-bsaed supply-driven model
  • Lower extremity stent implants
    • 386,000  529,000 over last 5 years
cost efficacy
Cost-efficacy
  • Impact of initial revascularization strategy?
  • Driven by durability and longitudinal cost-of-care
  • Initial procedural cost and resource utilization likely favors endovascular-first
  • Long-term implications unknown
tasc ii c d sfa
Open

Endovascular

TASC II C+D SFA

$12,366 ± 496

$7,540 ± 416

$335 ± 150

$226 ± 85

Stoner JVS 2008.

comprehensive review
Comprehensive review
  • SVS CE committee / Mayo systematic review
  • 1,371 candidate studies  19 papers

Moriarty JVS 2011 in press.

non standardized
Non-standardized
  • No coherent set of reporting or outcome variables
  • May favor bypass-first over time
  • Reporting standards?

Moriarty JVS 2011 in press.

cli strategy
CLI strategy

Critical Limb Ischemia

Bypass

Endovascular

OPTIMIZE

Healing

Amputation

basil 2005
BASIL 2005

Adam Lancet 2005.

basil 2010
BASIL 2010

Trend BSX advantage after 24 months

Bradbury HTA 2010.

basil
BASIL
  • High-quality RCT, however…
    • May lack external validity (technological advancement)
    • Trend towards BSX better outcomes
    • Lacking patient-centric outcome
  • Early cost advantage of ET lost over time (re-intervention)
  • Role for survival prediction models
cli strategy1
CLI strategy

Critical Limb Ischemia

PRIMARY AMPUTATION?

Bypass

Endovascular

Healing

Amputation

primary amp
Primary amp
  • Stroke / debilitated patient
  • Atretic limb
  • Flexion contracture
  • Functional dependence
  • What factors predict failure from CLI revascularization attempt?
    • Should these patients be counseled for amputation?

Commonly cited

in (sparse) literature

SottiuraiSemVascSurg 2007.

surgeon v patient endpoints
Surgeon v. Patient endpoints

75% Patency

89.5% Limb salvage

96% Survival

Traditional

52.6% fully functional

31.6% partially functional

13.2% totally dependent

Patient-centric

Kumar Ann VascSurg 2011.

functional status and success
Functional status and success
  • a priori functional status key
  • Patient-centric  when is amp better?

Some portion of this 59.1% are better off with amp

Taylor JVS 2009.

Taylor JVS 2006.

endo tech data void
Endo tech data void
  • Explosion of new catheter-based devices
  • Industry-sponsored and single-center trials
    • Lesion-based endpoints
    • May not scale to re-world practice
    • Often with historical controls
    • Restricted study populations
      • i.e. LACI trial and ESRD
slide23
Atherectomy in the real-world

LACI – 92%

52%

  • Less dissection & stent use
  • PTA w/ selective stent = ATH
  • ? Cost differential

Semaan VES 2010.

Stoner JVS 2007.

best medical therapy
Best medical therapy
  • Anti-platelet, statin, ACEI/ARB, cilostazol, smoking cessation – all have role
  • ~40m over 2y
  • No baseline correlates of success

PandeVasc Med 2010.

exercise pad
Exercise & PAD

Our patients

McDermott JAMA 2009.

exercise v endovascular
Exercise v. Endovascular

Spronk Radiology 2009.

exercise pta
Exercise  PTA
  • Optimized patient population
  • QoL (SF36) measures NS

Greenhalgh EJVES 2008.

clever trial
CLEVER trial
  • Aortoiliac disease
  • Moderate-severe claudicants
    • Best medical therapy (20%)
    • PTA / Stent (40%)
    • Exercise (40%)

Murphy JVS 2009.

clever outcomes
CLEVER outcomes
  • Primary Endpoint— MWD on graded treadmill test (Gardner protocol)
  • Secondary Endpoints— Community-based walking (pedometers), QoL, cost-effectiveness, cardiovascular disease risk markers (BMI, waist circumference, lipid profile, blood pressure, glycemic control)

Murphy JVS 2009.

endovascular surveillance
Endovascular surveillance
  • Mismatch between symptoms and duplex velocity?
  • Criteria for re-intervention unclear

Bui JVS 2011.

pad data shortcomings
PAD & data shortcomings
  • Outcome measures  patient centric
    • Claudication: QoL and walking measures
    • CLI: MALE, functional status, ambulatory status, longitudinal resource use
  • Poor adherence to clinical reporting standards
    • Patient or modality-based?
pad and new devices
PAD and new devices
  • Device-specific versus Patient-specific outcomes
    • TLR? Binary restenosis? LLI?
    • Especially with cell-based therapies
  • Cost and utilization of new technology
    • Current literature dated, and sparse
    • Longitudinal databases; ? Role for VQI
    • Development of reference data for FDA
treatment effectiveness
Treatment effectiveness
  • Episodic or global payment models
    • PAD treatment is chronic disease management
  • Patient, anatomic and socioeconomic correlates of success/failure
  • Define role of medical optimization at all stages
  • The workup “imaging cascade”
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