PAD can be diagnosed in asymptomatic individuals by a combination of physical examination and simple, noninvasive Doppler ultrasonography to measure the ankle–brachial index

1. D R N A J E E B U L L A H S O F I
L P S I N S T I T U T E O F C A R D I O L O G Y
PAD
Lower Extremity Interventions

2. Peripheral artery disease (PAD) is a common manifestation of
atherosclerotic disease that leads to impaired circulation to the lower
extremities.
 In epidemiological studies, the global population with PAD is estimated
to exceed 200 million individuals, and this figure has risen by >20% over
the past decade.
The prevalence of PAD increases with age, from ~5% in individuals aged
40–50 years to nearly 20% in octogenarians.
Major risk factors for PAD include diabetes mellitus, cigarette smoking,
dyslipidaemia, and hypertension.

3. Symptomatic + Asymptomatic PAD

8. Common Sites of Claudication
25-30%
80-90%
Tibial and
peroneal arteries
40-50% Foot

9. Vascular Anatomy of the Lower Extremity
 The abdominal aorta bifurcates at the
level of the fourth lumbar vertebra.
 The inferior epigastric artery
arises medially from the distal external
iliac artery and ascends behind the
rectus abdominis muscle. This vessel is
a useful landmark in predicting higher
bleeding risk in arterial punctures
proximal to its origin.

10. 1. Inflow of the lower extremity : the common iliac and
the external iliac arteries.
2. Outflow of the lower extremity: The CFA, SFA, DFA,
and the popliteal artery.
3. Runoff vessels: anterior tibial artery, posterior tibial
artery, and the peroneal artery

11. Diagnosis
 The majority of individuals
with PAD have no or minimal
symptoms.
 PAD can be diagnosed in
asymptomatic individuals by a
combination of physical
examination and simple,
noninvasive Doppler
ultrasonography to measure the
ankle–brachial index.

12.  The prevalence of PAD based on ankle–brachial index screening is 3–
10% in epidemiological studies, but the majority of these individuals are
asymptomatic.
 Patients with symptomatic PAD generally present with one of the two
major clinical syndromes:
1. Intermittent claudication or atypical ischaemic leg pain,
2. Chronic limb-​threatening ischaemia (CLTI).
 The presentation, prognosis, and treatment goals for these two
subgroups are distinct.

13. Ankle-Brachial Index
 ratio of the blood pressure in the
dorsalis pedis or the posterior
tibial artery, whichever is higher,
to the blood pressure in the
brachial arteries.
 The resting ABI should be used to
establish the lower extremity PAD
diagnosis in patients
with suspected lower extremity
PAD, defined as individuals with
one or more of the following:
1. exertional leg symptoms
2. nonhealing wounds,
3. age 65 and older,
4. 50 years and older with a history
of smoking or diabetes.
Supine Resting
ABI
Postexercise ABI
Normal >1.0 >1.0
Mild 0.8–0.9 >0.4
Moderate 0.4–0.8 >0.2
Severe <0.4 <0.2

14.  The use of Exercise ABI may be
helpful in equivocal cases.
 For this, the patient walks on the
treadmill at a constant speed of 1
to 2 miles per hour and at a 10% to
12% incline for 5 minutes, or the
exercise can be done with active
pedal plantar flexion.
 A decrease of at least 15 mm Hg
in the ankle systolic pressure
following the exercise challenge is
considered an abnormal test.
 The Toe-brachial index (TBI)
should be used to establish a
diagnosis in patients in whom
lower extremity PAD is clinically
suspected but in whom the ABI test
is not reliable because of
noncompressible vessels (usually
patients with long-standing
diabetes or advanced age).
 A TBI below 0.7 is considered
abnormal.

16. Pulse Volume Recording
 Plethysmography is used to detect
volumetric changes in the lower
extremity blood flow and is performed
with pressure cuffs inflated to 60 to 65
mm Hg at various segments of the
lower extremity.
 A normal tracing will have a rapid
systolic upstroke and downstroke with a
prominent dicrotic notch.
 This pattern changes as PAD develops
and progresses, with a noted
attenuation and widening of the arterial
waveform.
 Ultimately, the waveform becomes flat
(nonpulsatile) in patients with advanced
PAD

17. Segmental Pressures/ Pulse Volume Recordings

18. Segmental Doppler pressures and
Volume plethysmography
 Mild --absence of a
dicrotic notch
 progressive obstruction--
the upstroke and
downstroke become
equal
 severe disease--
amplitude of the
waveform is blunted.

19. Segmental Blood Pressure Duplex ultrasound
 For this test, a series of blood pressure cuffs
are placed at the level of the thigh (one or
two cuffs), calf, ankle, foot, and the big toe.
 These cuffs are then inflated sequentially to
about 20 mm Hg above the systolic pressure
in that segment. The cuff pressure is then
released slowly, and a continuous-wave
Doppler probe is used to obtain the pressure
at each segment.
 A decrease between two consecutive levels
of 30 mm Hg or more indicates the presence
of a stenosis in the segment proximal to the
blood pressure cuff. Also, the presence of a
20- to 30-mm Hg difference in the pressure at
one limb, when compared with the
contralateral limb at the same level, is
suggestive of significant PAD proximal to the
cuff in that limb.
 uses a 5- to 7.5-MHz transducer to
assess and characterize
suprainguinal and infrainguinal
PAD with a high sensitivity and
specificity (over 90%).

20. CTA MRA
 CTA has 93% sensitivity and 96% specificity
in detecting greater than 50% stenosis in
lower extremity PAD with high accuracy
when compared with digital subtraction
angiography (DSA).
 CTA is highly accurate for assessment of
PAD in detecting stenosis of the aortoiliac
and femoral arteries.
 However, diagnostic accuracy of CTA in
below-knee vessels is poor and contrast
angiography should be considered where
below-knee disease needs to be
accurately identified.
 reported sensitivity and specificity
for detecting stenosis greater than
50% of about 90% and 100%,
respectively.
 The principle role of MRA is in the
initial evaluation for PAD,
especially in patients with inflow
disease, using “bolus chase” 3-D
imaging, in which a single bolus of
contrast is followed to the foot.

21. Contrast Angiography
 contrast angiography remains the gold
standard.
 Traditionally, a pelvic/abdominal
aortogram in the anteroposterior
projection is done using a straight
pigtail catheter (5 or 6 Fr) placed at the
level of the L1-L2 vertebrae.
 Approximately 10 to 15 mL of
isoosmolar contrast is injected at a rate
of 15 mL/s with DSA technology. This
allows an excellent view of the distal
aorta, the origin of the common iliac
arteries, and the external iliac and
common femoral arteries.
 Angulated views (left anterior oblique
[LAO] of 30 degrees) can then be used
to visualize the iliac and femoral
bifurcations without overlap.

 Next, the pigtail catheter is placed above
the aortic bifurcation (L3 to L4) and DSA
with bolus chase, 8 mL/s for 10 seconds,
is used to assess the outflow and distal
runoff.
 Selective injections and sheath injections
can then be used to further define the
territory of interest as needed. The use of
“road map” technology can be used
subsequently to help operators in their
intervention and placement of balloons
and stents.

22. Treatment Goals
 Lower extremity peripheral artery disease (PAD) is associated with considerable
morbidity, diminished quality of life, and mortality; reducing the risk of cardiovascular
events is the primary goal of medical treatment.
 Intermittent claudication is the most common symptom of PAD; treatment aims to
improve ambulatory function through smoking cessation, medical therapy, exercise,
and (selective) revascularization.
 Chronic limb- threatening ischaemia is associated with increased amputation risk and
mortality; treatment is based on effective revascularization, which aims to relieve pain,
heal wounds, and preserve limb function.
 Advances in endovascular technologies and open surgical approaches have created a
growing range of revascularization options for PAD, although their outcomes are highly
dependent on the anatomical pattern of disease.

23. Components of optimal medical therapy for PAD
1. Smoking cessation
2. Antiplatelet therapy
3. Statin therapy
4. Treatment of hypertension (with an angiotensin- converting enzyme inhibitor or
angiotensin- receptor blocker as the first choice) to recommended goals
5. Treatment of diabetes mellitus to recommended goals
6. Trial of cilostazol (100 mg twice daily) for intermittent claudication, unless
contraindicated owing to heart failure
7. Supervised exercise therapy (goal: 30 min of walking 3–5 times each week)
8. Monitoring for treatment effects and signs of progression to chronic limb- threatening
ischaemia .

24. Intermittent claudication
 With appropriate treatment, the annual rate of major amputation in patients with
intermittent claudication is <1%, and <10% of patients progress to CLTI.
 Noninvasive and objective assessments of haemodynamic compromise, such as resting
and/or treadmill ankle–brachial index, are important to document both the severity of
disease and responses to treatment. However, haemodynamic measures and
findings on anatomical imaging studies correlate poorly with
functional impairment in patients with intermittent claudication.
 Thus, treatment of these patients generally involves a staged approach that initially
emphasizes lifestyle changes (such as smoking cessation), medical therapy, and
supervised exercise. An individualized risk–benefit analysis is essential before
considering invasive procedures.

25. Critical limb ischemia (CLI)
 Critical leg (or limb) ischemia (CLI) is characterized by persistent rest pain with or
without ongoing tissue loss, ischemic ulceration, or gangrene.
 The term critical limb ischemia is traditionally used to describe patients with
ischemic symptoms of more than 2 weeks duration.
 Patients with CLI usually have ankle systolic pressure below 40 mm Hg, toe systolic
pressure below 30 mm Hg, reduced transcutaneous oxygen concentration (TCPO2)
of less than 50 mm Hg, or combinations of these.
 In general, the underlying etiology is almost exclusively atherosclerosis, and
frequently it is a multivessel and multisegment disease. Smoking and diabetes are
the most potent risk factors and are associated with higher rates of amputation.
 The prognosis in patients with CLI is poor secondary to comorbid conditions:
mortality rates approach 10% per year, and amputation rates of 25% to 45% at 1
year.

26. Chronic limb- threatening ischaemia
 Goals of treatment in CLTI include pain relief, wound healing, and preservation
of a functional limb.
 In the absence of effective revascularization, >20% of patients with CLTI
require a major amputation within 12 months, and a similar proportion die
from cardiovascular causes.
 This high-risk population of patients requires rapid assessment, comprehensive
medical management, effective limb revascularization, and coordinated wound
and foot care to achieve positive outcomes for life and limb.

27. Medical therapies for PAD
 Antithrombotic therapy: The role of antiplatelet therapies
in patients with PAD is not yet fully defined. Current practice guidelines
recommend monotherapy with either aspirin or clopidogrel for the secondary
prevention of cardiovascular events in patients with PAD.
 Statins: The benefit of statins in preventing cardiovascular events
probably results from pleiotropic effects beyond their lipid-lowering function.
 Statins reduce both cardiovascular events and all-cause mortality in patients
with PAD and are considered a cornerstone of secondary prevention.
 Statins have also shown positive results on limb-related outcomes in patients
with CLTI, including improved claudication, prolonged walking time, improved
infrainguinal autogenous graft patency rates, reduced restenosis rates, and
improved limb salvage after intervention.

28.  ACE inhibitors and ARBs
 All current guidelines advise antihypertensive therapy in patients with
hypertension and PAD to achieve systolic and diastolic blood pressures of <140
mmHg and <90 mmHg, respectively, which are effective in preventing major
adverse cardiovascular events.
 ACE inhibitors and ARBs both have secondary prevention benefits beyond their
blood-pressure-lowering function in patients with PAD.

29.  Cilostazol is an oral
phosphodiesterase 3 inhibitor that induces
smooth muscle relaxation and reduces
platelet aggregation.
 Cilostazol improved claudication and
maximum walking distance by 35–67% in
patients with intermittent claudication.
 Moreover, treatment with cilostazol is
associated with reduced in-stent restenosis
after drug-eluting stent placement in
femoropopliteal lesions, reduced
reintervention rates after endovascular
intervention, and a decreased amputation
risk.
 Guidelines recommend cilostazol as a first-
line treatment in patients with PAD but
without heart failure (cilostazol is
contraindicated in heart failure)
 Naftidrofuryl is a serotonin-
receptor antagonist that is at least as
effective as (and probably more
costeffective than) cilostazol treatment
in patients with claudication.
 Studies of pentoxifylline have yielded
conflicting results. Pentoxifylline is less
effective than either cilostazol or
naftidrofuryl in reducing symptoms in
patients with intermittent claudication.
Consequently, pentoxifylline is not
currently recommended for the
treatment of PAD.

30. Treatment of PAD
Effect of Drug Therapy on Walking Distance
Hiatt WR. N Engl J Med. 2001; 344;1608-1621.
Meta-analysis of 4 randomized, placebo-controlled trials
Pentoxifylline, 1200 mg/day
698Cilostazol, 200 mg/day
Cilostazol, 200 mg/day
516
Compound, dose N
Cilostazol, 100 mg/day
Cilostazol, 200 mg/day 239
1.0 1.4 1.60.80.6
Cilostazol, 200 mg/day 81
1.8
Placebo
1.2
Relative Increase in Maximum Walking Distance
(ratio of change in exercise performance versus placebo)
Treatment Favored

31. Revascularization of advanced PAD
 Endovascular revascularization
Techniques:
1. Balloon angioplasty
2. Drug- coated balloon
3. Bare- metal stents
4. Drug- eluting stents
5. Covered stents
6. Atherectomy
 Advantages
1. Minimally invasive
2. Low morbidity
3. Often repeatable
4. Favourable outcomes in large arteries,
short lesions, and stenosis (versus
occlusion)
 Limitations:
1. Long lesion length, small vessel
diameter, and severe calcification
2. Common femoral artery and popliteal
artery disease is unfavourable
3. Reduced anatomic durability for
femoropopliteal and infrapopliteal
interventions
4. In- stent restenosis is difficult to treat

32. Open surgical revascularization
 Techniques:
1. Endarterectomy
2. Open bypass using prosthetic or
autogenous vein conduits
 Advantages:
1. Flexibility to address diverse
anatomic patterns and lesions
2. Can be combined with endovascular
revascularization in hybrid
approaches
3. Improved anatomical durability
 Limitations:
1. Invasive and increased risk for patient
2. Wound morbidity and systemic
complications
3. Adequate- quality autogenous vein is
absent in 20–40% of patients who require
a distal bypass
4. Poor outcomes for non- autogenous
conduits in below- knee bypass

33. .
Hybrid (simultaneous open surgical and
endovascular) procedures require an
operating room equipped with advanced
imaging capability, such as digital
subtraction angiography.
Hybrid approaches: for simultaneous, multilevel vascularization
of advanced PAD

34. Indications Revascularization Options
1. Symptom relief in patients with IC who
failed medical therapy
2. Management of CLI (rest pain, ulceration,
or gangrene) prior to a planned distal
lower extremity bypass surgery to restore
or to preserve the inflow to the lower
extremity
3. in preparation for other invasive
procedures, such as the placement of an
intraaortic balloon pump (IABP)
4. for treatment of flow-limiting
dissection following invasive
catheterization-based procedures.
 Occlusive disease confined to the iliac
arteries appears to occur in relatively
young patients and may therefore have
a greater impact on productivity and
lifestyle.
 These patients, over 90% of whom
were smokers, were otherwise healthy
compared with those with infrainguinal
disease or more diffuse PAD.
 In general, any type of
revascularization for this subset of
patients can offer satisfactory long-term
results.
Iliac Artery Intervention for Inflow Disease

35.  Historically, aortobifemoral bypass surgery has been the gold standard for
PAD that involves the iliac arteries, because this procedure is associated with
excellent long-term patency rates (85% to 90% at 5 years, 75% to 80% at 10 years,
and 60% at 20 years)
 However, it may be associated with an intraoperative mortality of roughly 1% to 3%
and a major complication rate of 5% to 10%. This, combined with the excellent
intermediate- to long-term patency rates following percutaneous intervention, has
led to the emergence of percutaneous revascularization as an attractive
alternative to surgery in patients with suitable lesions for such intervention.
 In a Swedish RCT in which 37% of randomized patients had iliac artery
stenosis, equivalence in outcomes was evident between percutaneous
transluminal angioplasty (PTA) and surgery. In the iliac disease subgroup, the
patency rate at 1 year was 90% in the PTA arm versus 94% in the surgical arm.

36. Aortofemoral Bypass Percutaneous Intervention
 Primary patency at 5 years
of 81-85%
 Perioperative mortality 5-
8%
 Reserved for severe
diffuse disease cases
• Patency at 5 years of 65-
80%
• Perioperative mortality
0.1%
• Treatment of choice
Revascularization for Aorto-Iliac Arterial Disease

38. Lesion-guided approach for treatment of
aorto-iliac disease
TASC II 2007
A
Endovascular is
procedure of
choice
B
Endovascular is
preferred
therapy
C
Surgery is
preferred for
good-risk
D
Surgery is
procedure of
choice

39. • Both balloon- and self-expandable stents
can be used in aortoiliac disease.
• The balloon-expandable stent is
advantageous in the context of an aortic
bifurcation lesion, in which kissing stents
are usually placed. It is also superior to
self-expandable stents when precision in
stent placement is needed.
• The self-expanding stent provides the
flexibility in flexion points, which reduces
the risk of stent deformity and fracture,
and is ideal in the setting of common iliac
lesions that do not involve the ostium and
those in the external iliac artery.
• Self-expanding stents were generally
favored for the external iliac artery
because they reduce the perforation risk.
Clinical Data
• PTA can effectively alleviate patients’
symptoms, improve treadmill distance,
and improve ABI during a short-term
follow-up period, although these
benefits are mostly lost by 2 years.
• Overall, for iliofemoral lesions, the
clinical results of percutaneous
revascularization are generally
comparable to those of surgical
bypass or reconstruction.
• A Swedish trial randomized patients with
threatened limb loss (40% with rest pain or
gangrene) or claudication who did not
improve with exercise training (60%) to
either PTA or surgical revascularization. No
differences were found between the PTA or
surgery treatment groups with regard to 1-
year primary and secondary patency rates.
Stent Choice

40.  A strategy of primary stenting, as opposed to provisional stenting, is generally
recommended for aortoostial lesions.
 A strategy of routine implantation of a Palmaz balloon-expandable stent gave
results that were superior to PTA in an RCT of 185 patients by Richter and
colleagues. The authors reported a 4-year patency rate of 94% in the stent arm
versus 69% with PTA. Cumulative clinical success, defined as improvement of
clinical stage of one level or more, was 89% for stenting and 67% for PTA,
respectively.
 At this time, stenting is an effective primary therapy for common iliac artery and
external iliac artery stenoses and occlusions.

41. Treatment outcomes in extensive aortoiliac occlusive PAD

42. Femoropopliteal Intervention for Outflow Disease
 Although controversial, many clinicians believe CFA revascularization should
be done surgically.
 Concerns about elastic recoil and dissection following PTA and concerns about
mechanical compression of stents and acute stent thrombosis have limited
endovascular intervention to this territory. PTA has been used in cases of
severe fibrotic lesions following previous surgery.
 The SFA and the proximal popliteal artery are the most common anatomic sites
of stenosis and occlusion in patients with IC. It is estimated that slightly more
than a quarter of diseased SFAs progress over a 3-year period, and 17% may go
on to occlusion
 Surgery remains the gold standard when therapy is indicated, and primary
femoropopliteal graft patency rates of about 80% at 5 years have been
documented

43. Femoro-Popliteal Bypass Surgery Femoro-Popliteal Angioplasty
• Primary patency at 5 years of
60-80%
• Autologous veins preferred
to synthetic grafts
• Perioperative mortality 0-3%
• Patency at 2-5 years ranges
between 40-70%
• Technical problems due
several anatomic issues:
• Occlusions vs stenosis
• Diffuse disease
• Adductor canal
• Disease in run off vessels
• Perioperative mortality is very
low
Revascularization for Femoro-Popliteal Disease

46. Lesion-guided approach for treatment of
femoro-popliteal disease
TASC II 2007
A
Endovascular
is procedure of
choice
D
Surgery is
procedure of
choice
B
Endovascula
r is preferred
therapy
C
Surgery is
preferred for
good-risk

47.  Femoropopliteal angioplasty can be considered for discrete single lesions
less than 10 cm, less than 5 cm for calcified stenosis, or less than 3 cm for
multiple lesions, so long as the SFA origin or distal popliteal artery is not
involved.
 Common Femoral Artery:
1. Stents have historically not been recommended.
2. Stents are routinely used in salvage situations, and the flexible self-
expanding stent is the appropriate choice in this vessel.
3. Stenting, however, poses many concerns because stent compression or
fracture can occur and may render future surgical repair more
complicated.
4. It is important to point out that although restenosis rates are high in the
CFA (>50%), restenosis may be associated with less limiting symptoms in
patients who needed the PTA for persistent or critical symptoms.

48.  In a meta-analysis of 934 patients, Mwipatayi and colleagues concluded that
stent placement in femoropopliteal occlusive disease does not increase the
patency rate when compared with PTA alone at 1 year.
 If stenting is indicated, self-expanding nitinol stents are generally used
in SFA lesions in light of the high risk of stent compression and fracture.
 One small randomized study of 104 patients suggested that treatment of SFA
disease by primary implantation of a self-expanding nitinol stent yielded
results superior to those with the currently recommended approach of balloon
angioplasty with optional secondary stenting at 6 to 12 months.

49.  The use of sirolimus-eluting S.M.A.R.T. stents for SFA occlusion was evaluated in the
Sirolimus-Eluting Versus Bare Nitinol Stent for Obstructive Superficial Femoral
Artery Disease (SIROCCO II) study and did not show any significant differences
in clinical outcome compared with bare-metal stents (BMSs).
 Dake and colleagues compared the 12-month safety and effectiveness of the Zilver PTX
with PTA and provisional BMS placement in patients with femoropopliteal PAD.
Compared with the PTA group, the primary DES group exhibited superior 12-month
event-free survival (90.4% vs. 82.6%, P = .004) and primary patency (83.1% vs.
32.8%, P < .001). Overall, femoropopliteal PAD treatment with the PES was
associated with superior 12-month outcomes compared with PTA
and provisional BMS placement.
 The Zilver PTX is the first and only DES approved by the U.S. Food and Drug
Administration (FDA) for SFA lesions.

50. Lesion Type and
Year After
Treatment
Balloon Dilation
Stent
Implantation
Patency
(%)a
Range
(%)
Patency
(%)a
Range
(%)
Stenosis
0 100 98–100 100 99–100
1 77 78–80 75 73–79
2 66 63–71 67 65–71
3 61 55–68 66 64–70
4 57 54–63 NA NA
5 55 52–62 NA NA
Occlusio
n
0 88 81–94 99 92–100
1 65 55–71 73 69–75
2 54 45–61 66 61–68
3 48 40–55 64 59–67
4 44 36–53 NA NA
5 42 33–51 NA NA
Lesion Type and
Year After
Treatment
Balloon Dilation Stent Implantation
Patency
(%)a
Range
(%)
Patency
(%)a
Range
(%)
Stenosis
0 83 69–88 100 94–100
1 60 46–63 74 68–80
2 49 35–54 66 59–72
3 43 30–51 65 58–71
4 40 26–46 NA NA
5 38 24–44 NA NA
Occlusio
n
0 70 62–75 98 94–100
1 47 40–51 73 68–75
2 36 28–41 65 60–68
3 30 20–37 63 58–68
4 27 16–34 NA NA
5 25 13–32 NA NA
IC CLI

53. When to Refer to Surgery
 Although somewhat controversial, surgery remains the preferred
strategy for patients with common femoral and proximal DFA
obstructive PAD.
 It is also the preferred strategy for patients with a:
1. heavily calcified completely occluded CFA,
2. femoropopliteal calcified stenosis,
3. occlusions more than 15 cm in length,
4. total occlusions (TOs) of the SFA that are more than 20 cm,
5. TOs of the popliteal artery or of the proximal trifurcation.

54. Infrapopliteal (Runoff) Disease
 Infrapopliteal disease can be challenging to treat, because the arteries
below the knee are small in calibre and tend to be calcified. Often,
diffuse disease is present in multiple vessels.
 Because of the complexity of these lesions, long term patency rates are
low, and endovascular intervention should be limited to patients with
CLTI.
 Although endovascular intervention has a high technical success rate
and confers minimal morbidity, the restenosis and clinical failure rates
are substantial.
 A 2016 meta analysis of infrapopliteal balloon angioplasty reported a 1-
year primary patency rate of 63%, a major amputation rate of 15%, and
mortality of 15%

56.  Endovascular therapy has had a limited role in the management of
infrapopliteal PAD.
 In patients with IC secondary to infrapopliteal PAD, medical therapy is
the most appropriate initial strategy.
 Tibioperoneal angioplasty is limited by recurrence and also by the
need for skilled operators, because the need for emergency surgical
bailout is associated with considerable risk that cannot be
justified in patients with stable IC, especially when medical
management is known to produce similar outcomes with limited risk.
 The role of angioplasty in patients with CLI is more promising and
justified because its results are comparable, if not superior, to
infrapopliteal/tibial bypass surgery.

57.  Balloon angioplasty remains the mainstay of infrapopliteal endovascular
intervention.
 Stents are not recommended in the management of infrapopliteal disease;
however, stent placement may be used as a bailout in the context of flow-
limiting dissections.
 The PADI trial was a prospective, multicenter, randomized, controlled, double-
arm study to investigate the safety and efficacy of Primary PES implantation
versus PTA in infrapopliteal lesions in CLI. The 5-year rates of amputation- and
event-free survival (survival free from major amputation or reintervention) were
significantly higher in the DES arm compared with PTA—BMS (31.8% vs.
20.4%, P = .043; and 26.2% vs. 15.3%, P = 0.041, respectively), but survival
rates were comparable.
 However A meta analysis of six prospective, randomized trials that compared
percutaneous transluminal angioplasty with primary stenting demonstrated
no significant differences between the two treatment groups with regard to
rates of technical success, primary patency, secondary patency, limb salvage,
or patient survival

58.  The use of Drug coated balloon angioplasty in infrapopliteal arteries is an
important area of ongoing active investigation in patients with.
 In the management of Infrapopliteal disease, bypass surgery has
been associated with disappointing results.
 Bypass to small calibre (≤3 mm) target arteries is technically challenging and is
highly dependent on the availability of a high quality venous conduit, preferably the
great saphenous vein.
 The use of a prosthetic conduit for bypass to distal arteries is associated with
dramatically reduced patency rates and increased amputation rates.
 The 5-year patency rate for femoral below-knee bypass is about 75% (vein graft) to
60% (prosthetic grafts), whereas for distal bypass, it is about 50%.

59.  An important contributor to these poor outcomes is the substantial disease
burden in this cohort of patients, who have a preponderance of coronary
artery disease (CAD), diabetes mellitus, and baseline tissue loss (foot
ulcer, gangrene, or nonhealing wound).
 DEB compared with PTA strikingly reduce 1-year restenosis, target lesion
revascularization, and target vessel occlusion in the treatment of below-
the-knee lesions in diabetic patients with CLI.
 Compared with DEB in long infrapopliteal lesions, DES were associated
with significantly lower residual immediate postprocedure stenosis and
significantly reduced restenosis at 6 months.
 Current guidelines espouse the angiosome concept for infrapopliteal CLI,
which entails establishing direct blood flow to the infrapopliteal artery
directly responsible for perfusing the region of the leg or foot with the
nonhealing wound.

60. THANK YOU