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Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease DR NG WAI KIN Introduction With aging population and increasing prevalence of metabolic syndrome, peripheral arterial disease (PAD) becomes an important burden to developed cities and countries. PAD can result in complications such as lifestyle-limiting claudication, critical limb ischemia (CLI) and amputation. Treatment of PAD includes pharmacotherapy as well as endovascular and surgical revascularization Indication for Revascularization Severe intermittent claudication failed conservative management (2) Critical limb ischemia, salvageable and functional limb (3) In patients with reasonable quality of life and life expectancy (2) Surgery vs Endovascular intervention BASIL Trial (5) UK-based multicenter RCT Intention-to-treat analysis Study peroid 1999-2004 452 patients randomized to bypass surgery and endovascular group Interim analysis at 2005, final analysis 2010 Include patient with severe limb ischemia Main end points: amputation free survival and overall survival Amputation free survival P value: <2 years: 0.85 >2 years: 0.11 Overall survival P value: <2 years: 0.32 >2 years: 0.009 Limitation High immediate failure rate of 20% in endovascular group Most case only perform percutaneous transluminal angioplasty (PTA) with very low use of stent (only 9 cases) Technical Successful Rate >90% Much more then just a balloon Methods of Endovascular Intervention Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent Guidewire, microcatheter, re-entry device, Pedal puncture DES BMS SUPERA Endovascular Intervention PTA Percutaneous Transluminal Angioplasty (PTA) Standard for revascularization in lower limb arteries Repeatability, low complication rate, less invasive nature (7) Initial success rate up to 90% (7) Percutaneous Transluminal Angioplasty (PTA) High rate of restenosis up to 40-60% at 12-month follow-up (8) Reintervention of restenosis is associated with worsened surgical outcomes and increased morbidity and mortality (9) Endovascular Intervention PTA BMS Bare Metal Stent Self-expanding nitinol stent is most commonly used in lower limb arteries Stent or not? Randomized control trials comparing PTA and primary stenting at SFA (10) Stent or not? In general, stenting offers superior results to PTA in longer lesions (≥6 cm), in chronic total occlusions, and in heavily calcified arteries Stenting is also indicated if there is a suboptimal result after PTA (10) ◦ ◦ ◦ ◦ flow-limiting dissection after PTA a residual stenosis <50% leading to flow limitation acute or subacute recoil >50% leading to flow limitation acute or subacute reocclusion after PTA. Stent Restenosis Problems with stenting ◦ Daily activities e.g. walking exert mechanical forces which can result in material fatigue and fracture of stents ◦ Multiple overlapping stents may cause metal-to-metal hinge points that initiate the fracture process (26) Endovascular Intervention PTA BMS SUPERA SUPERA stent •Newly designed interwoven nitinol stent with the advantage of • Mimics natural structure and movement of vessel walls • High compression resistance, kink resistance and fracture resistance (37) •Improve patency rate for popliteal disease and heavily calcified lesions. Restenosis Problems with stenting ◦ Daily activities e.g. walking exert mechanical forces which can result in material fatigue and fracture of stents ◦ Multiple overlapping stents may cause metal-to-metal hinge points that initiate the fracture process (26) ◦ Micromovement of stent on the vessel wall creates repetitive friction and inflammation ◦ Growth and migration of vascular smooth-muscle cells result in neointimal proliferation Endovascular Intervention PTA DES BMS SUPERA Drug-Eluting Stents (DES) Immunosuppressants are used to inhibit restenosis via a coated stent platform Local drug delivery can achieve higher tissue concentrations of drug without systemic effect (18) Drug-Eluting Stents (DES) Initial result is not promising SIROCCO trial (19, 20) ◦ In-stent restenosis rate at 24-month, measured by duplex ultrasound ◦ DES group: 22.9% ◦ BMS group: 21.1% (P>0.05) ◦ Limitation ◦ Unexpectedly low restenosis rate of BMS group ◦ Excessive stent fracture rate (36% in DES group) Drug-Eluting Stents (DES) Paclitaxel-eluting stent (Zilver PTX) ◦ Higher antiproliferative agent dosing density ◦ Lack of binding polymer to reduce risk of mechanical stress ◦ Zilver PTX Randomized Study (21) ◦ 12-month patency rate ◦ DES: 89.9% ◦ PTA or provisional BMS: 73% ◦ 5-year primary patency rate ◦ DES: 66.4% ◦ PTA or provisional BMS: 43.4% ◦ Stent fracture rate 0.9% at 12-month Endovascular Intervention DCB PTA DES BMS SUPERA Drug-Coated Balloon (DCB) Direct delivery of antiproliferative drug to vessel wall Drug-Coated Balloon (DCB) Potential advantage (10) ◦ Homogenous drug delivery (cf concentration gradients produced by DES) ◦ Immediate drug release without the use of polymer that can induce chronic inflammation ◦ Application in locations where stent implantation is not desirable (e.g. CFA, Popliteal artery) Drug-Coated Balloon (DCB) THUNDER Trial (27) ◦ 12-month binary restenosis rate ◦ DCB 24% vs PTA 50% (P<0.05) ◦ 5-year target lesion revascularization rate (TLR) ◦ DCB 21% vs PTA 56% (p=0.0005) FemPac Trial (28) ◦ 24-month TLR ◦ DCB 13% vs PTA 50% (p=.0001) LEVANT 1/2 Trial (29, 30) ◦ Highly powered 54-sited RCT, 476 patients in 2:1 ratio ramdonization ◦ 12-month patency rate ◦ DCB 65.2% vs PTA 52.6% (P=0.02) Drug-Coated Balloon (DCB) Potential problem (10) ◦ Failure to provide mechanical saffold for the prevention of acute recoil ◦ Inability to treat dissection flaps ◦ Low drug concentration reaching vessel wall due to calcified plaques Endovascular Intervention DCB PTA Bioabsorbable stent DES BMS SUPERA Bioaborbable DES Most bioresorbable stents are made of polylactic acid, a naturally dissolvable material that is used in medical implants such as dissolving sutures. No comparative analysis available now Drug-Coated Balloon (DCB) Potential problem (10) ◦ Failure to provide mechanical saffold for the prevention of acute recoil ◦ Inability to treat dissection flaps ◦ Low drug concentration reaching vessel wall due to calcified plaques Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent DES BMS SUPERA Atherectomy Atherectomy is a endovascular technique where atheroma is excised Principle base on plaque removal to increase the gain in lumen size Particularly useful in restenosis or excessively calcified vessels Atherectomy DAART: Directional Atherectomy plus Anti-Restenotic Therapy Aim at improving the acute procedural success and prepare the vessel for drug delivery ◦ Pilot study: the DEFINITIVE AR Trial ◦ higher technical success rate in the DAART arm vs. DCB arm (89.6% vs. 64.2%, p = 0.004) ◦ The incidence of flow-limiting dissection in the combination arm (DAART) was almost zero ◦ Duplex Ultrasound patency at 12 month: 93.4% for DAART vs. 89.6% for DCB alone ◦ Better patency rate in long lesions >10cm and heavily calcified lesions. How to improve successful rate Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent Guidewire, microcatheter, re-entry device, Pedal puncture DES BMS SUPERA Success of endovascular procedure 1. Passage of recanalization wire through the obstruction 2. Removal of obstruction by endovascular tool 3. Keeping the artery open in short and long term (10) Success of endovascular procedure 1. Passage of recanalization wire through the obstruction 2. Removal of obstruction by endovascular tool 3. Keeping the artery open in short and long term (10) Advancement in Guidewires Variety of recanalization wires (0.035”, 0.018”, 0.014” systems) Difference in tip load, wire coating, shaft stiffness Development of micro-supporting catheters Re-entry device Primary limitation for chronic occlusion is failure to re-enter the true lumen after subintimal crossing of occlusion ~20% unsuccessful true lumen reaccess (34) Re-entry device typically use a nitinol tip to help re-entry of guidewires to true lumen Pedal Puncture Useful approach when (35) ◦ antegrade recanalization fails ◦ Occlusion being flush with the origin of a trifurcation artery ◦ Difficult subintimal tract formation from antegrade approach due to heavily calcified plaque ◦ Inability to reenter the true lumen Can be performed using ultrasound or fluoroscopic guidance Conclusion With the advancement of techniques and devices, endovascular revascularization becomes the first choice for revascularization in majority of cases Enjoy the benefit of less invasive, lower operative risk, fewer surgical complication, with similar patency rate as surgical revascularization However, surgical bypass still have a role in good risk patient with diffused and difficult lesions. More researches is required on drug-eluting device and stent-less technology Don’t Forget Smoking Cessation Optimal control of BP, lipid level, DM Supervised exercise program Medication ◦ Antiplatelet therapy ◦ Cilostazol Reference 1. 2. 3. 4. 5. 6. 7. 8. 9. Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):13291340. Jeffrey L. Anderson, et al; Management of Patients With Peripheral Artery Disease (Compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations) A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:1425-1443. 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Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATEBTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013;128(6):615–621. Zeller T, Baumgartner I, Scheinert D, et al.; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64(15):15681576. Ambler GK, Radwan R, Hayes PD, Twine CP. Atherectomy for peripheral arterial disease. Cochrane Database of Systematic Reviews. March 2014 Smith M, Pappy R, Hennebry T A. Re-Entry Devices in the Treatment of Peripheral Chronic Occlusions. Texaz Heart Ins J. 2011;38:392-397 Reference (Continued) 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. Sabri S S, Hendricks N, et. al. Retrograde Pedal Access Technique for Revascularization of Infrainguinal Arterial Occlusive Disease. J Vasc Radiol. 2015;26:29-38 Matsagkas M, Kouvelos G, Arnaoutoglou E et al: Hybrid procedures for patients with critical limb ischemia and severe common femoral artery atherosclerosis. Ann Vasc Surg 2011; 25:1063–1069 SUPERA 500: Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a selfexpanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861868. http://www.hopkinsmedicine.org/healthlibrary/test_procedures/cardiovascular/angioplasty_and_stent_place ment_for_the_heart_92,p07981/ http://www.emsworld.com/article/11359780/understanding-restenosis-following-coronary-angioplasty-andstenting http://multimediacapsule.thomsonone.com/medtronic/medtronic-drug-coated-balloon-receives-fda-approvalfor-treating-peripheral-artery-disease-in-upper-leg https://lookfordiagnosis.com/mesh_info.php?term=atherectomy&lang=1 http://www.nature.com/nmat/journal/v8/n6/fig_tab/nmat2462_F1.html http://www.daviddarling.info/encyclopedia/S/stent.html http://evtoday.com/images/articles/2014-10/werner-f1.jpg Appendix Limitation Most PAD requiring intervention is characterized by >1 lesion, at >1 level Base on practice patterns, technical consideration, morbidity and expert consensus Lack of head-to-head comparative effectiveness trials Did not include infrapopliteal classification Primary utilized as an anatomical classification BASIL BASIL Latest Guideline European Society of Cardiology Guideline 2011 (3) ◦ When revascularization is indicated, an endovascular-first strategy is recommended in all aortoiliac and femorpopliteal TASC A–C lesions. (Class I, Level C) ◦ A primary endovascular approach may be considered in aortoiliac TASC D lesions in patients with severe comorbidities, if done by an experienced team. (Class IIb, Level C) Society for Vascular Surgery Guideline 2015 (6) ◦ We recommend endovascular interventions as first-line revascularization therapy for most patients with common iliac artery or external iliac artery occlusive disease causing IC. (Grade 1, Level B) ◦ We recommend endovascular procedures over open surgery for focal occlusive disease of the SFA artery not involving the origin at the femoral bifurcation. (Grade 1, Level C) Latest Guideline European Society of Cardiology Guideline 2011 (3) ◦ Aortoiliac lesions ◦ When revascularization is indicated, an endovascular-first strategy is recommended in all aortoiliac TASC A–C lesions. (Class I, Level C) ◦ A primary endovascular approach may be considered in aortoiliac TASC D lesions in patients with severe comorbidities, if done by an experienced team. (Class IIb, Level C) ◦ Femoropopliteal lesions ◦ When revascularization is indicated, an endovascular-first strategy is recommended in all femoropopliteal TASC A–C lesions. (Class I, Level C) ◦ A primary endovascular approach may also be considered in TASC D lesions in patients with severe comorbidities and the availability of an experienced interventionist. (Class IIb, Level C) ◦ Infrapopliteal lesions ◦ When revascularization in the infrapopliteal segment is indicated, the endovascular-first strategy should be considered. (Class IIa, Level C) Latest Guideline American Heart Association Guideline 2013 (2) ◦ Intermittent claudication ◦ Endovascular intervention is recommended as the preferred revascularization technique for TASC type A iliac and femoropopliteal arterial lesions. (Level of Evidence: B, Class I recommendation) ◦ Critical limb ishcemia ◦ For patients with … an estimated life expectancy of 2 years or less in patients in whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible … (Level of Evidence: B, Class IIa recommendation) ◦ For patients with … an estimated life expectancy of more than 2 years, bypass surgery, when possible and when an autogenous vein conduit is available, is reasonable to perform as the initial treatment ... (Level of Evidence: B, Class IIa recommendation) Latest Guideline Society for Vascular Surgery Guideline 2015 (6) ◦ Intermittent claudication ◦ We recommend endovascular procedures over open surgery for focal AIOD causing IC. (Grade 1, Level B) ◦ We recommend endovascular interventions as first-line revascularization therapy for most patients with common iliac artery or external iliac artery occlusive disease causing IC. (Grade 1, Level B) ◦ We recommend endovascular procedures over open surgery for focal occlusive disease of the SFA artery not involving the origin at the femoral bifurcation. (Grade 1, Level C) ◦ We recommend surgical bypass as an initial revascularization strategy for patients with diffuse FP disease, small caliber (<5 mm), or extensive calcification of the SFA, if they have favorable anatomy for bypass (popliteal artery target, good runoff) and have average or low operative risk. (Grade 1, Level B) Stent or not? Aortoiliac ◦ Dutch Iliac Stent Trial (11) ◦ Similar 2 year patency rate ◦ Primary stenting: 71% ◦ Balloon Angioplasty with selective stenting: 70% ◦ Long-term data on ankle-brachial index (ABI), iliac patency and quality of life did not support a difference between the 2 groups ◦ The use nitinol self expanding stent allows more procedural success and accurate placement the stainless steel stent (12) Stent or not? Infrapopliteal ◦ Stenting is not commonly used except for bailout stenting after dissection (4) Drug Eluting Stents (DES) Everolimus-eluting stent (Dynalink-E stent) ◦ ◦ ◦ ◦ High drug payload Long elution profile Stent design less prone to fatigue and fracture STRIDES trial (22) ◦ Primary patency ◦ 6-month: 94% ◦ 12-month: 68% ◦ No stent fracture *Cover stent Viabahn VIASTAR Drug Eluting Stents (DES) Below-theknee lesion Mean Lesion Length (mm) 12-month primary patency rate DES PTA 200 27 81% 58% YUKON-BTK (24) 161 31 81% 56% 0.004 DESTINY (25) 17 85% 54% 0.0001 ACHILLES (23) • • • Suject No. 140 P-value BMS 0.006 Morphological improvement has not yet translated into improved clinical parameters (e.g. limb salvage rates, reduced mortality and reintervention) (10) Low patient number in studies Only available in short length Drug-Coated Balloon (DCB) DEBATE-BTK trial (31) ◦ Single center RCT, 158 patient ◦ 12-month stenosis rate ◦ DCB 27% vs PTA 74% (p<0.001) Drug-Coated Balloon (DCB) IN.PACT DEEP Trial (32) ◦ ◦ ◦ ◦ 358 patients DCB vs PTA to treat infrapopliteal disease No difference in target lesion revascularizatrion and late luminal loss Trend towards major amputation (DCB 8.8% vs PTA 3.6%, p=0.08) Withdrawal of product from market Hybrid Procedures Endovascular treatment to improve in-flow or out-flow lesions, in combination with open surgery ◦ Iliac artery angioplasty + CFA endarterectpmy/ FP bypass (36) ◦ Above-knee bypass + below-knee angioplasty ◦ SFA angioplasty + popliteo-distal bypass Pedal Puncture and Pedal Arch Reconstruction Bioaborbable DES Drug-Eluting Stent Drug-Coated Balloon Atherectomy Angiosome