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Peripheral Arterial Disease SVS Clinical Research Priorities Michael C. Stoner, MD East Carolina Heart Institute East Carolina University Department of.

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Presentation on theme: "Peripheral Arterial Disease SVS Clinical Research Priorities Michael C. Stoner, MD East Carolina Heart Institute East Carolina University Department of."— Presentation transcript:

1 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

2 PAD Epidemiology 8 – 12 million Americans –12 – 15% of population over 65 years Hirsch Vasc Med 208. Allison JVS 2009. Ciriqui Circulation 2005. Selvin Circulation 2004.

3 Limb Salvage (CLI pts) HI LI P < 0.05 Durham JVS 2010.

4 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.

5 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.

6 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

7 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

8 TASC II C+D SFA $335 ± 150 $226 ± 85 $7,540 ± 416 $12,366 ± 496 Open Endovascular Stoner JVS 2008.

9 Comprehensive review SVS CE committee / Mayo systematic review 1,371 candidate studies  19 papers Moriarty JVS 2011 in press.

10 Non-standardized No coherent set of reporting or outcome variables May favor bypass-first over time Reporting standards? Moriarty JVS 2011 in press.

11 CLI strategy Critical Limb Ischemia Endovascular Bypass Amputation Healing OPTIMIZEOPTIMIZE

12 BASIL 2005 Adam Lancet 2005.

13 BASIL 2010 Bradbury HTA 2010. Trend BSX advantage after 24 months

14 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

15 CLI strategy Critical Limb Ischemia Endovascular Bypass Amputation Healing PRIMARY AMPUTATION?

16 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 Sottiurai Sem Vasc Surg 2007.

17 Surgeon v. Patient endpoints 75% Patency 89.5% Limb salvage 96% Survival Kumar Ann Vasc Surg 2011. 52.6% fully functional 31.6% partially functional 13.2% totally dependent Traditional Patient-centric

18 Functional status and success a priori functional status key Patient-centric  when is amp better? Taylor JVS 2006. Taylor JVS 2009. Some portion of this 59.1% are better off with amp

19 Functional status and BKA Agle SCVS 2009.

20 VariablesOdds Ratio Confidence Interval P-value Pre-op non-ambulatory18.783.69 – 95.46<0.001 COPD 5.041.18 – 21.63 0.030 No popliteal pulse 3.271.56 – 6.85 0.002 ESRD 2.651.06 – 6.65 0.038 History of CVA 2.571.01 – 6.52 0.047 Female 2.251.06 – 4.78 0.036 Rehab – composite failure Agle SCVS 2009.

21 Role of emerging technologies Goodney JVS 2009.

22 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

23 52% Atherectomy in the real-world Stoner JVS 2007. LACI – 92% Less dissection & stent use PTA w/ selective stent = ATH ? Cost differential Semaan VES 2010.

24 Patient-centric claudication

25 Best medical therapy Anti-platelet, statin, ACEI/ARB, cilostazol, smoking cessation – all have role Pande Vasc Med 2010. ~40m over 2y No baseline correlates of success

26 Exercise & PAD McDermott JAMA 2009. Our patients

27 Exercise v. Endovascular Spronk Radiology 2009.

28 Optimized patient population QoL (SF36) measures NS Exercise  PTA Greenhalgh EJVES 2008.

29 CLEVER trial Aortoiliac disease Moderate-severe claudicants 1.Best medical therapy (20%) 2.PTA / Stent (40%) 3.Exercise (40%) Murphy JVS 2009.

30 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.

31 Endovascular surveillance Mismatch between symptoms and duplex velocity? Criteria for re- intervention unclear Bui JVS 2011.

32 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?

33 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

34 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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