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Endovascular Treatment of Peripheral Artery Disease in VA Healthcare System

Endovascular Treatment of Peripheral Artery Disease in VA Healthcare System. Subhash Banerjee, MD, FACC, FSCAI Chief, Division of Cardiology VA North Texas Health Care System Dallas, TX. SCAI 2014, Las Vegas, AZ. Endovascular Interventions in Veterans Affairs Health Care System.

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Endovascular Treatment of Peripheral Artery Disease in VA Healthcare System

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  1. Endovascular Treatment of Peripheral Artery Disease in VA Healthcare System Subhash Banerjee, MD, FACC, FSCAI Chief, Division of Cardiology VA North Texas Health Care System Dallas, TX SCAI 2014, Las Vegas, AZ

  2. Endovascular Interventions in Veterans Affairs Health Care System • Evolving trends in endovascular interventions: • National trends • VA trends • Patient outcomes: • Medical therapy • Detection of PAD in Veteran population • Dual anti-platelet therapy (DAPT) • Interventional therapies: • Chronic total occlusions (CTO) • Drug-coated balloons (DCB) & drug-coated stents (DCS) • VA training programs • PAD research in the VA

  3. Endovascular Interventions in Veterans Affairs Health Care System • Evolving trends in endovascular interventions: • National trends • VA trends • Patient outcomes: • Medical therapy • Detection of PAD in Veteran population • Dual anti-platelet therapy (DAPT) • Interventional therapies: • Chronic total occlusions (CTO) • Drug-coated balloons (DCB) & drug-coated stents (DCS) • VA training programs • PAD research in the VA

  4. PAD: Endovascular Intervention, Surgery & Amputation Trends: 1996-2006 3x growth in endovascular interventions Total endovascular interventions RR=3.3; 95% CI 2.9-3.8 400 300 Major LE amputation RR=0.71; 95% CI 0.7-0.8 Number of procedures /100,000 Medicare beneficiaries 200 LE bypass surgery RR=0.58; 95% CI 0.5-0.7 100 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years J Vascular Surgery 2009; 50:54-60

  5. PAD Endovascular Intervention Trends: 1996-2006 Total endovascular interventions RR=3.3; 95% CI 2.9-3.8 400 300 Angioplasty RR=2.5; 95% CI 2.2-2.8 Number of procedures /100,000 Medicare beneficiaries 200 Atherectomy RR=43.1; 95% CI 34.8-52.0 100 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years J Vascular Surgery 2009; 50:54-60 PAD: peripheral artery disease

  6. PAD Operator Trends: 1996-2006 Cardiologist RR=2.5; 95% CI 2.2-2.8 400 Vascular surgeon RR=2.5; 95% CI 2.2-2.8 300 Interventional radiologist RR=2.5; 95% CI 2.2-2.8 Number of procedures /100,000 Medicare beneficiaries 200 100 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years J Vascular Surgery 2009; 50:54-60

  7. Proportion of PAD Endovascular Intervention: 1996-2006 100 10% Vascular surgeons 80 40% 23% 60 Cardiologists Proportion of all endovascular procedures 40 41% 67% Radiologists 20 19% 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years J Vascular Surgery 2009; 50:54-60

  8. U.S. PAD Trends: 2004-2013 Number of Annual Procedures Estimated Annual Cost 4.3 2.0 3.6 3.2 1.3 USD (billion) PVI (million) 0.9 • Endovascular interventions ~1.5x coronary interventional volume • Endovascular interventional market annual growth rate >8% • Peripheral artery drug-coated stents (DCS): fastest growing sector • CTO crossing device: third highest growth after DES and drug-coated balloons PVI: peripheral vascular interventions CTO: chronic total occlusion DCS & DES (drug-eluting stent) interchangeable U.S. Market Report. Lifesciences Intelligence Inc. May 2014

  9. Complication Rates for Endovascular vs. Open Revascularization: 1998 vs. 2007 New York State inpatient and outpatient database New York State inpatient and outpatient database Egorova et al. J Vasc Surg. 2010

  10. PAD Trends in Veterans: 2000-2004 VA inpatient and outpatient database 82% increase in patients with established PAD diagnosis 739,377 82% increase Patients 405,580 Diabetes Care 34:1157–1163, 2011

  11. Endovascular Interventions in Veterans Affairs Health Care System • Evolving trends in endovascular interventions: • National trends • VA trends • Patient outcomes: • Medical therapy • Detection of PAD in Veteran population • Dual anti-platelet therapy (DAPT) • Interventional therapies: • Chronic total occlusions (CTO) • Drug-coated balloons (DCB) & drug-coated stents (DCS) • VA training programs • PAD research in the VA

  12. Predictive Value of ABI in Patients with Established CAD (XLPAD® Registry) Prevalence of Abnormal ABI in Patients with Stable CAD n=679 ABI=0.9-1.4 (38.7%) ABI<0.9 (58.4%) www.xlpad.org ABI>1.4 (2.9%) ABI: ankle-brachial index, CAD: coronary artery disease, Normal ABI (>0.9 and <1.4), Abnormal ABI (<0.9 and >1.4) Banerjee et al. Am J Cardiol. 2014 Apr 15;113(8):1280-4

  13. Predictive Value of ABI in Patients with Established CAD (XLPAD® Registry) Freedom form Major Adverse Cardiovascular Events (MACE) No DM, Normal ABI (Reference group) DM, Normal ABI (HR=1.7, 95% CI: 0.71-4.06, p=0.24) No DM, Abnormal ABI (HR=2.03, 95% CI: 0.83-4.98, p=0.12) DM, Abnormal ABI (HR4.85, 95% CI: 2.22-10.61, p=0.0001) No DM, Normal ABI DM, Normal ABI No DM, Abnormal ABI DM, Abnormal ABI ABI: ankle-brachial index, CAD: coronary artery disease, Normal ABI (>0.9 and <1.4), Abnormal ABI (<0.9 and >1.4) Banerjee et al. Am J Cardiol. 2014 Apr 15;113(8):1280-4

  14. Annual Mortality of Veterans with PAD:DM vs. Non-DM VA inpatient and outpatient database-1998 33,629 patients with PAD; 9,474 (29%) with DM* 1.0 0.8 0.6 Survival probability 0.4 0.2 0.0 • 60-day mortality no different, • Mortality significantly increased at 6m for DM subjects (9.8% vs 8.4%, p<0.001) &continued to 8y 500 1000 1500 2000 2500 3000 Follow-up (days) Diabetics Non-diabetics *VA Austin database Kamleshat al. Clin. Cardiol. 32, 8, 442–446 (2009) Log-rank, p-value <0.001

  15. Statin Therapy & Limb Outcomes in Patients with PAD: (REACH Registry) n=5,861 4-year follow-up % Worsening PAD (competing risks) Worsening PAD Worsening claudication/ new CLI New limb revascularization New amputation • Prior studies have documented improvements in walking distance & coronary revascularization • This is the first study to demonstrate the impact of statins on adverse limb outcomes Kumbhamiet al. EHJ 2014

  16. Endovascular Revascularization & Supervised Exercise For Claudication (ERASE Trial) Multicenter Randomized Clinical Trial (n=106) (n=106) Maximum walking distance (m) Endovascular revascularization plus supervised exercise therapy is associated with greater improvement in functional performance in patients with PAD Fakhryet al. AHA 2013 Late-breaking trial

  17. CASPER Trial: DAPT After Peripheral Arterial Bypass Surgery Overall: HR=0.98; 95% CI: 0.78-1.23) 100% ASA+Clopidogrel (n=426) 75% Proportion event-free (%) 50% Primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR=0.65; 95% CI: 0.45-0.95; p=0.025) ASA+Placebo (n=425) 25% 0 50 100 150 200 250 300 350 400 450 500 550 No significant difference in severe bleeding: clopidogrel+ASA=2.1% vs. ASA+placebo=1.2% DAPT: Dual anti-platelet therapy Belch et al. J Vasc. Surg. October 2010

  18. Major Adverse Event (MAE)-Free Survival with≤3m or >3m of DAPT 0.68 p=0.0024 0.55 MAE-free Survival ≤3 months DAPT >3 months DAPT ≤ 3 months DAPT (n=203) > 3 months DAPT (n=131) Months Das S et al. SCAI Annual Mtng. 2014

  19. Lower Extremity Amputation Trends Veterans with PAD: 2000-2004 VA inpatient and outpatient database 82% increase in patients with established PAD diagnosis 7.08 34% decline 4.65 Amputations/1000 patients Diabetes Care 34:1157–1163, 2011

  20. Endovascular Interventions in Veterans Affairs Health Care System • Evolving trends in endovascular interventions: • National trends • VA trends • Patient outcomes: • Medical therapy • Detection of PAD in Veteran population • Dual anti-platelet therapy (DAPT) • Interventional therapies: • Chronic total occlusions (CTO) • Drug-coated balloons (DCB) & drug-coated stents (DCS) • VA training programs • PAD research in the VA

  21. Crossing Peripheral CTO (XLPAD® Registry) a b c • 40-50% patients with symptomatic PAD have a peripheral artery CTO1 Proximal cap Side branch CTO body Figure: (a) Parts of a typical SFA CTO (b) Inability to direct the wire in a SFA CTO (c) Formation of a wire loop and passage advanced through the sub-intimal space. Arrow head indicates the width of the wire loop and the size of the potential sub-intimal space created Distal cap Distal target vessel ABI: ankle-brachial index, CAD: coronary artery disease, Normal ABI (>0.9 and <1.4), Abnormal ABI (<0.9 and >1.4) 1Norgen et al. J Vasc Surg 2007; 45: S5-67

  22. Peripheral Artery CTO: Surgery vs. PVI • Adam et al. Lancet 2005;366:1925–1934 • Wolf et al. JVIR 1993;4:639-648 • McQuade et al. J Vasc Surg 2010;52:584-91 PVI: peripheral vascular intervention

  23. Peripheral Artery CTO: Crossing Studies Femoropopliteal Wire-catheter vs. Crossing Device Outcomes 1. Van der Heijden FH et al. Br J Surg 1993;80:959-63; 2. Banerjee S. et al. J Am Coll Cardiol 2012; 3. Galassi AR et al. J Invasive Cardiol 2011;23:359–362; 4. Charalambous N et al. Cardiovasc Intervent Radiol 2010;33:25-33; 5. Banerjee S et al. JEVT 2014; 6. Zeller T et al. JEVT 2012; 7. Mossop PJ et al. CCI 2006; 8. Staniloae CS et al. JIC 2011; 9. Banerjee et al. JEVT 2014; 10. Banerjee et al. JIC 2014 (accepted); 11. Pigott et al. J Vasc Surg. 2012. ★CrossBossTM is the same device as VianceTM

  24. Peripheral Artery CTO: Stent Studies 1. Hong et al. JEVT 2013;20:782–791 ; 2. Lagana et al. Radiol Med 2011;116:444–453; 3. Lagana et al. Radiol Med 2008; 113:567-577; 4. Dosluoglu et al. J Vasc Surg 2008;48:1166–1174; 5. Banerjee et al. J Am Coll Cardio 2012; 60(15): 1352-1359; 6. Lepantalo et al. Eur J Vasc Endovasc Surg 2009;37:578–584; 7. Farraj et al. J Invasive Cardiol. 2009 Jun;21(6):278-81; 8. Boisiers et al. J Cardiovas Surg 2013;54(1):115-22

  25. Crossing Peripheral CTO (VA Cooperative Trial; VA CSP 598) Flowchart of the proposed study design. SFA = superficial femoral artery; CTO = chronic total occlusion; IVUS = intravascular ultrasound; BMS= bare metal Nitinol self-expanding stents; DES= drug-eluting Nitinol self-expanding stents; R = randomization; m = month; FU = follow-up; R1= first randomization based on either use of wire-catheter or dedicated crossing device; R2= second randomization to either drug-coated or bare Nitinol self-expanding stents; ABI= ankle-brachial index Banerjeeet al. VA CSP LOI, 2012

  26. Femoropopliteal Stent: Randomized Trials Low –Intermediate complexity patients (~30% DM) & lesions (Mean=69.6 mm) p<0.001 p=0.38 p=0.05 p=0.06 Restenosis (%) 31.7 38.6 24.0 43.0 25.0 45.0 18.7 63.3 n=51 n=53 n=51 n=53 n=134 n=72 n=123 n=121 FAST1 Schilinger Angio2 Schilinger DUS2 RESILIENT3 Stent PTA 12m 6m 6m 12m 3. Circulation: CV Interventions.2010; 3: 267-276 2. N Engl J Med 2006; 354:1879-1888 1. Circulation. 2007 Jul 17;116(3):285-92

  27. Peripheral Artery CTO: Treatment Strategy Cumulative Hazard of Restenosis (CTO vs. Non-CTO SFA Lesions) With Bare-Metal Stent Post-dilation Strategies HR=3.61, 95% CI 0.99 –13.18; p=0.05* Conventional CTO Conventional non-CTO Cryoplasty CTO Cryoplasty non-CTO HR=2.69, 95% CI 0.74 – 9.85; p=0.13* Cumulative hazard of restenosis HR=2.65, 95% CI 0.72 – 9.80; p=0.15* Reference Group Time (in days) *Comparedtoreferencegroup Banerjee et al. J Am Coll Cardio 2012; 60(15): 1352-1359

  28. Peripheral Drug Coated StentZilver PTX (Paclitaxel) Trial: Design 479 patients with Rutherford category ≥ 2 PAD symptoms Up to 2 lesions per SFA Femoro-popliteal lesions (n=508) 32.8% 83.1%* PTA n=251 DES n=247 Primary effectiveness end point: primary patency at 12 months. defined by DUS or angio “As prespecified, acute PTA failure was counted as a loss of patency for the primary effectiveness end point.” Failed PTA n=126 Optimal PTA BMS n=68 DES n=68 Lesion length = 64.8 mm CTO = 27.2% 89.9%* 73.0% Dake et al. Circ. Interv. Oct. 2011 PTA: balloon angioplasty; DES: drug-eluting stent; BMS: bare metal stent; *p≤0.01

  29. Peripheral Drug Coated Stents Karan Sarode, David Spelber et al. JACCI 2014 (accepted manuscript)

  30. Peripheral Drug Coated Balloons Karan Sarode, David Spelber et al. JACCI 2014 (accepted manuscript)

  31. Endovascular Interventions in Veterans Affairs Health Care System • Evolving trends in endovascular interventions: • National trends • VA trends • Patient outcomes: • Medical therapy • Detection of PAD in Veteran population • Dual anti-platelet therapy (DAPT) • Interventional therapies: • Chronic total occlusions (CTO) • Drug-coated balloons (DCB) & drug-coated stents (DCS) • VA training programs • PAD research in the VA

  32. VA Peripheral Artery Disease Research: 191 studies 2001-2014 www.clinicaltrials.gov

  33. Veteran Affairs Research Programs www.research.va.gov

  34. Endovascular Interventions in Veterans Affairs Health Care System • Period of rapid growth in endovascular interventions: • Prospective trials to establish the impact of ABI screening in asymptomatic individuals & in patients with established CAD • Medical interventions in PAD • Statin & DAPT interventions • Endovascular interventions in PAD • Refinement of CTO treatment • DCB and DCS trials • Growing role of VA sponsored clinical trials &databases

  35. Acknowledgements • Emmanouil S. Brilakis, MD, PhD • Clark Gregg, MD • John Rumsfeld, MD • Joseph Hill, MD, PhD • Anand Prasad, MD • Nicolas Shammas, MD • Osvaldo S. Gigliotti, MD • Mazen Abu Fadel, MD • Tayo Addo, MD • Mirza Shadman Baig, MD • Michael Luna, MD • DharamKumbhani, MD • Andrew Klein, MD • Jeffry Hastings, MD • Gerold Grodin, MD • Bernadette Speiser, RN • Shuaib Abdullah, MD • Joseph Garcia, MD • Knyugen Kytai, PhD • Xu Hao, PhD • Atif Mohammad MD • Preeti Kamath, BDS • Michele Lytal, RN • Evaster Bennett, LVN • Puja Garg, PhD • Swagata Das, MBBS • Karan Sarode, BS • Gene Pershwitz, MD • David Spelber, MD • SalilSethi, MD • Pooja Banerjee, MD • Bertis Little, PhD • Rick Weideman, PharmD • Kevin Kelly, PharmD • Cheryl Webb-Singh • Donald Haagan, RVT • Teresa Jeong, RN • Susan Droughty, RN • Lauren Makke, RVT • Dwaine William • Omar Hadidi, MD • Rahul Thomas, MD • OUR PATIENTS

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