Transcript Updates on Endovascular Revascularization for Lower

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
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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