Single Center Experience with Drug Eluting Stents
for Infrapopliteal Occlusive Disease in Patients with
Critical Limb Ischemia
Robert Lookstein MD FSIR
Associate Professor of Radiology and Surgery
Mount Sinai Medical Center
Critical Limb Ischemia
• Most severe form of Peripheral Arterial Disease (PAD).
• Over 100,000 lower extremity amputations are performed in
the United States (US) every year for CLI.
• In the United States, the amputation rate has increased from
19 30 per 100,000 persons years over the last two decades
primarily due to an increase in diabetes and advancing age.
• The prognosis for patients with critical limb ischemia is poor
– 25% mortality rate in first year
• (less than the survival rate of breast & colon cancers)
– 25% amputation rate in first year
– 50% of all below the knee amputation patients do not
survive beyond 5 years
Management of Critical Limb Ischemia
Goals –
• Restore adequate perfusion to the limb
• Reduce or eliminate ischemic pain
• Achieve wound healing and salvage the limb
Gold Standard is Surgical Bypass
• Many patients cannot be offered bypass surgery
• Severe medical comorbidity (cardiac, pulmonary)
• Inadequate conduit (poor vein)
Endovascular Therapy
• Can be initial treatment of choice
• Does not preclude subsequent bypass surgery
• Ideal for patients without conduit, severe medical
comorbidities
• Traditional therapy has been balloon angioplasty
with reported patency rates of 50% at one year
Objective
• Drug-eluting stents (DES) have
been shown to be effective in the
treatment of coronary artery
disease
• This study reports a single center
experience in the use of this
technology in the treatment of
infrapopliteal occlusive disease in
the setting of critical limb ischemia
Materials and Methods
• October 2005 to February 2010
• 56 patients 34 male, 22 female
– mean age 82, range 43-93
• ALL patients had symptoms of critical limb ischemia
at presentation prior to treatment
• All patients were considered poor surgical candidates
due to poor conduit or severe medical comorbidities
• All stents were placed following a suboptimal balloon
angioplasty result
Materials and Methods
Rutherford Class
40
30
20
10
0
Class 4
Class 5
Class 6
Demographics
 CAD
73.2% (41/56) DM
CAD
 DM 67.9% (38/56)
73.2%
End Stage
Renal Disease
67.9%
35.7%
 Chronic Renal Disease 35.7% (20/56)
(41/56)
(38/56)
(20/56)
Materials and Methods
• Primary endpoints
– technical success of the revascularization procedure
– primary patency
– freedom from major amputation
– survival at follow up
• All patients were placed on clopidigrel and aspirin
peri-procedurally and continued indefinitely
Results
 56 patients (34 men, 22 women)
(mean age 82, range 43-93)
63 angiographic lesions
 101 infrapopliteal drug eluting stents
 86 sirolimus, 13 evirolimus,
2 paclitaxel
2%
13%
85%
Results
• Initial technical success rate was 100%
– all treated lesions having less than 10%
residual angiographic stenosis following stent
placement
• Mean number of stents per patient 1.66
(range 1-5)
• Stent diameter - 2.5mm to 4mm
• Simultaneous femoral-popliteal intervention 37/56 (66%)
• Total occlusions - 22/63 (35%)
Follow-up
• Mean follow up was 24 months (1-42 months)
• Primary patency at 6 months was 71/79 stents
(90%)
• Primary patency at 12 months was 61/73
(84%)
• Primary patency at 24 months was 28/39
(72%)
• Freedom from major amputation was 89.3% (50/56) for the entire
cohort
• 100% (47/47) for patients with Rutherford category 4 and 5
disease.
• 30 day mortality rate was 1.8% (1/56)
• Overall mortality rate was 21.4% (12/56)
Primary Patency
DRUG ELUTING INFRAPOPLITEAL STENTS
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
0
0
60
120
180
240
300
360
420
480
540
600
660
720
780
27
27
27
27
27
27
TIME IN DAYS
Number at risk
101
82
70
61
61
61
61
27
FREEDOM FROM MAJOR AMPUTATION
DRUG ELUTING INFRAPOPLITEAL STENTS
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
0
0
60
120
180
240
300
Number at risk
56
47
41
35
35
35
360 420 480
TIME IN DAYS
35
15
15
540
600
660
720
780
15
15
15
15
15
Survival
DRUG ELUTING INFRAPOPLITEAL STENTS
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
0
0
60
120
180
240
300
Number at risk
56
47
41
35
35
35
360 420 480
TIME IN DAYS
35
15
15
540
600
660
720
780
15
15
15
15
15
Primary Patency
DRUG ELUTING INFRAPOPLITEAL STENTS
100
90
80
70
60
RUTHERFORD
4
5
6
50
40
30
20
10
0
0
60 120 180 240 300 360 420 480 540 600 660 720 780
TIME IN DAYS
Number at risk
Group: 4
20 19 14 11 11 11 11 5
5
5
5
5
5
5
Group: 5
66 57 52 49 49 49 49 22 22 22 22 22 22 22
Group: 6
15 6
4
1
1
1
1
0
0
0
0
0
0
0
FREEDOM FROM MAJOR AMPUTATION
DRUG ELUTING INFRAPOPLITEAL STENTS
105
95
85
75
65
RUTHERFORD
4
5
6
55
45
35
25
15
5
0
60 120 180 240 300 360 420 480 540 600 660 720 780
TIME IN DAYS
Number at risk
Group: 4
13 12 10 7
7
7
7
4
4
4
4
4
4
4
Group: 5
34 30 28 25 25 25 25 10 10 10 10 10 10 10
Group: 6
9
5
3
3
3
3
3
1
1
1
1
1
1
1
Survival
DRUG ELUTING INFRAPOPLITEAL STENTS
100
90
80
70
60
RUTHERFORD
4
5
6
50
40
30
20
10
0
0
60 120 180 240 300 360 420 480 540 600 660 720 780
TIME IN DAYS
Number at risk
Group: 4
13 12 10 7
7
7
7
4
4
4
4
4
4
4
Group: 5
34 30 28 25 25 25 25 10 10 10 10 10 10 10
Group: 6
9
5
3
3
3
3
3
1
1
1
1
1
1
1
77 year old male with
ischemic ulcer of the
right great toe
Following angioplasty
Following stent placement
65 year old female with
ischemic toe ulcer
Following angioplasty
Following stent placement
Following PTA Following DES
65 year old female
with ischemic rest pain
February 2006
March 2009
Three year follow up
Conclusions
 Placement of infrapopliteal drug eluting stents is
a safe and effective therapy following suboptimal
angioplasty in patients with critical limb ischemia
• This procedure has excellent technical success
and demonstrates:
– procedural safety
– high primary patency
– Excellent limb salvage rates
Implications
 This data supports the use of Drug Eluting Stents following
suboptimal infrapopliteal angioplasty in patients with
critical limb ischemia, especially Rutherford
category 4 and 5 disease
 Drug Eluting Stents can decrease re-intervention rates,
peri-procedural morbidity, and amputation rates in this high risk
patient population
 Patients should be aware that there are minimally invasive
treatment options for critical limb ischemia offered by
interventional radiologists to treat their symptoms and avoid
amputation