Current meta-analysis comparison between DCB and POBA in below-the-knee therapy

Transcription

1 Current meta-analysis comparison between DCB and POBA in below-the-knee therapy Jihad A. Mustapha, MD, FACC, FSCAI Director of Cardiovascular Research Metro Health Hospital Wyoming, MI Associate Clinical Professor of Medicine Michigan State University College of Osteopathic Medicine E. Lansing, MI

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Consulting Fees/Honoraria Abbott Vascular Bard Peripheral Vascular Boston Scientific Cardiovascular Systems, Inc. Cook Medical Medtronic Spectranetics Terumo

3 Infrapopliteal or Below the knee Arterial Disease Risk factors include diabetes, chronic kidney disease, and advanced age ( all on the rise ) Progresses to critical limb ischemia (CLI) Disease may be multi-level Higher risk for amputation with shorter amputation-free survival Goal: Re-establish direct flow through at least one infrapopliteal artery to reduce pain and promote wound healing. Notice, no mention of preventing Amp Gray BH, Diaz-Sandoval LJ, Dieter RS, Jaff MR, White CJ, Peripheral Vascular Disease Committee for the Society for Cardiovascular A and Interventions. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2014;84:

4 Types Vascular Smooth Muscle cells (VSMC) The two ends of a spectrum of VSMC: 1.Proliferative, synthetic VSMCs 2.Quiescent, contractile VSMCs 3.Intermediate phenotypes exist Differentiation and proliferation of VSMCs are not mutually exclusive Depending on the signals present in their local environment, contractile VSMCs can acquire distinct phenotypes with the ability to: migrate proliferate promote ECM production elicit inflammatory signals and/or calcification

5 Types Vascular Smooth Muscle cells (VSMC) The phenotypic modulation of VSMCs is determined by the environmental signals: mechanical forces endocytosis of specific molecules growth factors that influence expression of a panel of VSMCspecific genes inflammatory cytokines calcium-phosphate homeostasis oxidized phospholipids, retinoic acid involves multiple signaling pathways including MAPK kinases, Rho, Notch, BMP and β-catenin signaling

6 Location and Features Associated Condition(s) Calcific atherosclerosis Intimal; ossification Atherosclerosis, hyperlipidemia; osteoporosis; hypertension; inflammation Calcific medial vasculopathy (Mo nckeberg s medial calcific sclerosis) Tunica media Type 2 diabetes mellitus; endstage renal disease; hyperphosphatemia; amputation Elastocalcinosis Internal elastic lamina/interna External elastic Externa Pseudoxanthoma elasticum; Marfan syndrome ( concentric tibial calcification ) Calcific uremic arteriolopathy Microvessels; amorphous End-stage renal disease;

7 Infrapopliteal Treatment Trials Disappointing Results for 20 Years Distal Bypass POBA BMS DES (for mid and distal tibials) DCB Other Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. Journal of Vascular Surgery, Volume 47, Issue 5, 2008, e1 Bosiers, M., Deloose, K., Moreialvar, R., Verbist, J., & Peeters, P. (2008). Current status of infrapopliteal artery stenting in patients with critical limb ischemia. Jornal Vascular Brasileiro, 7(3), Rocha Singh, K. J., Jaff, M., Joye, J., Laird, J., Ansel, G., & Schneider, P. (2012). Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: The XCELL trial. Catheterization and Cardiovascular Interventions, 80(6),

8 Bypass Graft Option for good surgical candidates Comorbidities, inadequate conduit, lack of good distal target limit eligibility for many CLI patients Index limb re-operation within 3 months, hospital re-admission, and > 3 month wound healing time have been reported in the 50% range High morbidity/mortality rates & cost Bosiers, M., Deloose, K., Moreialvar, R., Verbist, J., & Peeters, P. (2008). Current status of infrapopliteal artery stenting in patients with critical limb ischemia. Jornal Vascular Brasileiro, 7(3), Rocha Singh, K. J., Jaff, M., Joye, J., Laird, J., Ansel, G., & Schneider, P. (2012). Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: The XCELL trial. Catheterization and Cardiovascular Interventions, 80(6),

9 POBA Meta-analysis ( ): Limb salvage rate was high Primary and secondary patency were low PTA had inferior primary and secondary patency but comparable limb salvage to open surgical procedures Meta-analysis estimates of primary patency (black line), secondary patency (gray line), limb salvage (red line). Marcello Romiti, Maximiano Albers, Francisco Cardoso Brochado-Neto, Anai Espinelli S. Durazzo, Carlos Alberto Bragança Pereira, Nelson De Luccia. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. Journal of Vascular Surgery, Volume 47, Issue 5, 2008, e1

10 POBA Kaplan-Meier life-table analysis of outcomes after angioplasty for CLI. Dashed line portion of plot where the SE is greater than 10%. Limb salvage rate was high Primary and secondary patency were low Purpose of treatment in this population is symptom relief rather than long-term patency Risk factor analysis showed hypertension, multiple segment lesions, more distal lesions, and TASC D lesions were predictors of worse longterm outcomes Toshifumi Kudo, Fiona Chandra, and Samuel Ahn. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: A 10-year experience. Journal of Vascular Surgery, Volume 41, Issue 3, 2005,

11 BMS Good limb salvage rates 12-month freedom from TLR 54.3% Rate of AEs 63.3%, largely due to high rate of TLR 12-Month amputation-free survival and limb salvage curves. Rocha-Singh, K. J., Jaff, M., Joye, J., Laird, J., Ansel, G., Schneider, P. and The VIVA Physicians (2012), Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: The XCELL trial. Cathet. Cardiovasc. Intervent., 80: doi: /ccd.24485

12 DES ACHILLES TRIAL SES group superior to PTA with freedom from death, TLR, bypass, amputation, and RC month vessel patency higher in SES vs. PTA (75% vs. 57.1%) META-ANALYSIS DES reduces risk of TLR, restenosis and amputation compared to PTA or BMS DES had no significant difference on mortality or RC improvement at 1 year Fusaro, M., Cassese, S., Ndrepepa, G., Tepe, G., King, L., Ott, I.,... & Kastrati, A. (2013). Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials. JACC: Cardiovascular Interventions, 6(12), Scheinert, D., Katsanos, K., Zeller, T., Koppensteiner, R., Commeau, P., Bosiers, M.,... & Van Ransbeeck, M. (2012). A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. Journal of the American College of Cardiology, 60(22),

13 DES DES trials limited to primarily focal lesions Stent deformation limits use in distal vessels A: Overall distribution and rates of stent fractures and compressions in various infrapopliteal anatomical levels B: Anatomical relationship of distal anterior tibial artery may render the vessel more prone to stent fatigue Scheinert, D. (2007). Update: drug-eluting stents in tibial arteries. Endovasc. Today, 8, Karnabatidis, D., Katsanos, K., Spiliopoulos, S., Diamantopoulos, A., Kagadis, G. C., & Siablis, D. (2009). Incidence, anatomical location, and clinical significance of compressions and fractures in infrapopliteal balloon-expandable metal stents. Journal of Endovascular Therapy, 16(1),

14 DCB Multiple randomized trials comparing DCB to POBA with varied results: DEBATE-BTK: DCB associated with significant reduction in binary restenosis, TLR and vessel occlusion at 12 months DEBELLUM: DCB demonstrated reduction in restenosis at 6 months IN.PACT DEEP: DCB had comparable efficacy, increased major amputation rates. BIOLUX: DCB outcomes comparable to PTA Fanelli, F., Cannavale, A., Boatta, E., Corona, M., Lucatelli, P., Wlderk, A.,... & Salvatori, F. M. (2012). Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial. Journal of Endovascular Therapy, 19(5), Zeller, T., Beschorner, U., Pilger, E., Bosiers, M., Deloose, K., Peeters, P.,... & Brodmann, M. (2015). Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P- II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC: Cardiovascular Interventions, 8(12),

15 DEBATE BTK - Binary restenosis 27% (DCB) vs. 74.3% (PTA) - Freedom from TLR significantly higher with DCB DCB IN.PACT DEEP - Binary restenosis 41% (DCB) vs. 35.5% (PTA) - Clinically driven TLR comparable, 11.9% (DCB) vs. 13.5% (PTA) - 12 month major amputation 8.8% (DCB) vs. 3.6% (PTA) - No major amputations in DCB group Liistro, F., Porto, I., Angioli, P., Grotti, S., Ricci, L., Ducci, K.,... & Bolognese, L. (2013). Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation, CIRCULATIONAHA-113. Zeller, T., Baumgartner, I., Scheinert, D., Brodmann, M., Bosiers, M., Micari, A.,... & Kent, K. C. (2014). Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN. PACT DEEP randomized trial. Journal of the American College of Cardiology, 64(15),

16 SIZE MATTERS!!! DEBATE BTK IN.PACT DEEP RVD = 2.44 mm RVD = 2.89 mm Potential Reasons for Success: Average DEBATE DCB balloon size was 0.56 larger than IN.PACT DEBATE pre-dilatation size ratio closer to 1:1 versus 0.9:1 with IN.PACT DEBATE acute luminal gain higher

17 Other Treatments Cryoplasty No long term benefit Cutting balloon No long term benefit Scoring balloon No long term benefit Based on comparative analysis

18 Is POBA the best option? Optimal infrapopliteal treatment modality remains controversial and PTA remains standard of care Contemporary meta-analysis performed ( ) to assess current PTA outcomes 1-year outcomes from contemporary meta-analysis comparable to Romiti meta-analysis: Technical success: 91% vs. 89% Primary patency: 63% vs. 58% Major amputation: 15% vs. 14% All-cause mortality: 15% vs. 13% Infrapopliteal PTA outcomes have not changed over last decade despite advanced knowledge and techniques Mustapha, J. A., Finton, S. M., Diaz-Sandoval, L. J., Saab, F. A., & Miller, L. E. (2016). Percutaneous Transluminal Angioplasty in Patients With Infrapopliteal Arterial Disease Systematic Review and Meta-Analysis. Circulation: Cardiovascular Interventions, 9(5), e

19 The real problem is NOT what we think It is ALL in the WALL is the problem Calcific medial vasculopathy (Mo nckeberg s medial calcific sclerosis) Tunica media Type 2 diabetes mellitus; end- stage renal disease; hyperphosphatemia; amputation Elastocalcinosis Internal elastic lamina/interna External elastic externa Pseudoxanthoma elasticum; Marfan syndrome (concentric tibial calcification)

20 Thank you Jihad A. Mustapha, MD, FACC, FSCAI Director of Cardiovascular Research Metro Health Hospital Wyoming, MI Associate Clinical Professor of Medicine Michigan State University College of Osteopathic Medicine E. Lansing, MI

21 Current meta-analysis comparison between DCB and POBA in below-the-knee therapy Jihad A. Mustapha, MD, FACC, FSCAI Director of Cardiovascular Research Metro Health Hospital Wyoming, MI Associate Clinical Professor of Medicine Michigan State University College of Osteopathic Medicine E. Lansing, MI