1. Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease
DR NG WAI KIN

2. 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
Systemic review 2013

3. 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)
The ACC/AHA guideline recommends evaluation for primary amputation of the leg in patients with any of the following:
Significant necrosis of weight-bearing portions of the foot
Uncorrectable flexion contracture
Paresis of the extremity
Refractory ischemic rest pain
Sepsis
Limited life expectancy
Invasive intervention for infrapopliteal disease is appropriate in patients with two- or three-vessel disease and (1) moderate-to-severe claudication with a focal arterial lesion; (2) ischemic foot pain during rest (Rutherford classification 4); or (3) minor and major (skin necrosis, gangrene) tissue loss

4. Surgery vs Endovascular intervention

6. BASIL Trial (5) UK-based multicenter RCT Intention-to-treat analysis
Study peroid
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
UK based

7. Amputation free survival Overall survival
P value:
<2 years: 0.32
>2 years: 0.009
P value:
<2 years: 0.85
>2 years: 0.11

8. 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

9. Methods of Endovascular Intervention

10. Endovascular Intervention
Atherectomy
DCB
PTA
Bioabsorbable stent
Guidewire, microcatheter, re-entry device,
Pedal puncture
DES
BMS
SUPERA

11. Endovascular Intervention
PTA

12. 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)
Worsen in longer lesion >10 cm

13. 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)

14. Endovascular Intervention
PTA
BMS

15. Bare Metal Stent
Self-expanding nitinol stent is most commonly used in lower limb arteries
Avoids the problems of
Early elastic recoil
Residual stenosis
Eliminates late lumen loss secondary to constrictive remodelling

16. Stent or not?
Randomized control trials comparing PTA and primary stenting at SFA (10)
The femoropopliteal segment remains the most challenging area with respect to restenosis and reocclusion after endovascular treatment. During movements like walking or stair climbing, various forces are exerted on this vessel, including flexion, longitudinal and lateral compression, and torsion, which may influence long-term outcomes after endovascular treatment.
13. FAST
Primary nitinol stenting (n=123) vs PTA (n=121). mean length 4.5cm
12 month binary restenosis rate (stent 31.7%, PTA 38.6%, p=0.377)
Stenosis rate of PTA were much lower than expected, so the trial was not powered to establish an absolute difference of 7%
High fracture rate upto 12%
14. RESILIENT
206 patient (2:1 randomization), 7.1cm mean length
12 months primary patency Stent 81.3% vs PTA 36.7%, p=0.0001)
15. ASTRON
73 patients, RCT, 8.2cm mean length
Binary restenosis rate stent 34.4% vs PTA 61.1%, p=0.028
16, 17 Vienna ABSOLUTE
104 patient, 10.1cm mean length
USG detected binary restenosis rate (stent 37% vs PTA 63%), p=0.01

17. 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.
Primary stenting with bare metal stent (BMS) does not improve restenosis rates

18. 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)
exerted various forces on to the vessel and the stent, including flexion, longitudinal and lateral compression, and torsion,

19. Endovascular Intervention
PTA
BMS
SUPERA

20. 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.
SUPERB 0.5% fracture rate in 2 years

21. 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

22. Endovascular Intervention
PTA
DES
BMS
SUPERA

23. 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)
The concept is based on the proven effectiveness decreasing restenosis and reintervention in interventional cardiology.

24. 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)
SIROCCO
2006
First published study on the use of sirolimus-eluting stents in human vasculature
93 patient, double blind RCT, 8.3cm

25. 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
Zilver PTX Randomized Study
N=479
Criticism: relatively short lesion (63-66mm), manufactory funded
Become a bare metal stent after 6 months
Animal study show loss of benefit after 12 months

26. Endovascular Intervention
DCB
PTA
DES
BMS
SUPERA

27. Drug-Coated Balloon (DCB)
Direct delivery of antiproliferative drug to vessel wall

28. 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)

29. 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)
THUNDER trial – initial experience
IN PACT SFA – small sample size (91 patients), short follow-up (12 month), no mention of systemic drug level
The IN.PACT Admiral DCB is the newest minimally-invasive treatment for PAD in the upper leg. It features a proprietary coating of the drug paclitaxel and a naturally occurring excipient called urea, which facilitates transfer of the drug from the balloon into the artery wall. Paclitaxel is delivered in a 3.5 µg/mm2 dose to maximize therapeutic benefit and remains at therapeutic levels for up to 180 days. The device is available in 40, 60, 80, and 120 mm lengths and can accommodate vessels ranging from 4–7 mm in diameter.

30. 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

31. Endovascular Intervention
DCB
PTA
Bioabsorbable stent
DES
BMS
SUPERA

32. 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
Drawbacks
recoil after expansion
stent thickness causing maneuverability and crossing issues
difficulty visualizing a non-metallic stent on fluoroscopy
stents not crimping firmly on delivery balloons. 

33. 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

34. Endovascular Intervention
Atherectomy
DCB
PTA
Bioabsorbable stent
DES
BMS
SUPERA

35. 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

36. 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 %, 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.
The use of Directional Atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract

37. How to improve successful rate

38. Endovascular Intervention
Atherectomy
DCB
PTA
Bioabsorbable stent
Guidewire, microcatheter, re-entry device,
Pedal puncture
DES
BMS
SUPERA

39. Success of endovascular procedure
Passage of recanalization wire through the obstruction
Removal of obstruction by endovascular tool
Keeping the artery open in short and long term (10)

40. Success of endovascular procedure
Passage of recanalization wire through the obstruction
Removal of obstruction by endovascular tool
Keeping the artery open in short and long term (10)

41. 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

42. 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
Subintimal angioplasty to isolate thrombogenic athroma and false lumen do not have endothelium for neointimal hyperplasia

43. 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

44. 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

45. Don’t Forget Smoking Cessation Optimal control of BP, lipid level, DM
Supervised exercise program
Medication
Antiplatelet therapy
Cilostazol

46. Reference
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ment_for_the_heart_92,p07981/
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51. Appendix

52. 2007

54. 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
Instead of guidance to which method of revascularization to use

55. BASIL

56. BASIL

57. 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)

58. 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)

59. 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)

60. 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)

61. 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)
11. Dutch iliac stent trial
Old trial 1998.
By doppler USG, Palmaz stent
Selective stent in_____
Long term?
Critism: very short and simple lesion and the fact that stenting may offer greater benefit s in more complex disease
12. CRISP-US trial
203 patients received either a nitinol self-expanding stent or a self-expanding Elgiloy stent after suboptimal iliac artery angioplasty
Lacking data comparing different type of stents

62. Stent or not? Infrapopliteal
Stenting is not commonly used except for bailout stenting after dissection (4)
Endovascular treatment for below-the-knee arteries is traditionally reserved for patients with critical limb ischemia. This condition is typically characterized by diffuse and long segmental disease of all 3 tibioperoneal arteries rather than by short focal obstructions. Conventional balloon angioplasty with long balloons and long inflation times frequently yields astonishingly good immediate results with the use of modern, low-profile, long-segment angioplasty balloons, which are available in up to 200-mm lengths. The restenosis rate with these long balloons is still considered extremely high, ranging between 60% and 80% at 6 months
Stenting with BMS, both self-expanding nitinol stents and modern balloon-expanding products, did not improve restenosis rates. Therefore, the use of BMS in below-the-knee arteries was restricted to spot stenting in bailout situations when balloon angioplasty failed. In terms of clinical outcomes like walking distance and limb salvage, data are still lacking.

63. 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
STRIDES trial single arm non-randomized, multicenter trial
N=104

64. *Cover stent
Viabahn
VIASTAR

65. Drug Eluting Stents (DES)
Below-the-knee lesion
Suject No.
Mean Lesion Length (mm)
12-month primary patency rate
P-value
DES
PTA
BMS
ACHILLES (23)
200 27
81%
58%
0.006
YUKON-BTK (24)
161 31
56%
0.004
DESTINY (25)
140 17
85%
54%
0.0001
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

66. 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)

67. 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
DCB composed of 3 components:
Platform (Balloon)
Drug
Drug carrier and spacer

68. 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
*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
Graft occlusion after bypass
Cause by neo-intimal hyperplasia or progression of atherosclerosis affecting inflow/ outflow tract
Direct catheter thrombolysis showed poor result in mid-late occlusion*
Surgical thrombectomy (rapid clot removal) + balloon angioplasty (treat underlying stenosis) in patient cannot tolerate re-operation or lack of autogenous conduit
*Nackman GB, Walsh DB, fillinger Mf et al: Thrombolysis of occluded infrainguinal vein grafts: predictors of outcome. J Vasc Surg 1997;25:1023–1031; discussion 1031–1022

69. Pedal Puncture and Pedal Arch Reconstruction

70. Bioaborbable DES
Drug-Eluting Stent
Drug-Coated Balloon

71. Atherectomy Devices Excimer Laser Excisional atherectomy
Rotational atherectomy

72. Angiosome
The concept of angiosome-directed therapy (ADT) has gained significant relevance. An angiosome is a three-dimensional anatomic unit of tissue
ANGIOSOME-DIRECTED THERAPY
ADT refers to the establishment of flow to the topographic area of the foot where the wound is located. This can be achieved via direct flow, defined as inline, pulsatile flow through the affected angiosome source artery, or indirect flow, represented by the strategy whereby flow to the wound area is provided by collaterals fed by an arterial conduit that is revascularized, as no direct flow is considered feasible.