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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 IschemiaGoals – • 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
0
10
20
30
40
Class 4 Class 5 Class 6
Rutherford Class
Demographics
CAD 73.2% (41/56)
DM 67.9% (38/56)
Chronic Renal Disease 35.7% (20/56)
CAD DM End Stage Renal
Disease73.2% 67.9% 35.7%
(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 85%
13%2%
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)
DRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
100959085807570656055504540353025201510
50
TIME IN DAYS
PR
IMA
RY
PA
TE
NC
Y (
%)
Number at risk101 82 70 61 61 61 61 27 27 27 27 27 27 27
Primary Patency
FREEDOM FROM MAJOR AMPUTATION DRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
10095908580757065605550454035302520151050
TIME IN DAYS
FR
EE
DO
M F
RO
M M
AJO
R A
MP
UT
AT
ION
(%
)
Number at risk56 47 41 35 35 35 35 15 15 15 15 15 15 15
SurvivalDRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
10095908580757065605550454035302520151050
TIME IN DAYS
Su
rviv
al p
rob
abil
ity
(%)
Number at risk56 47 41 35 35 35 35 15 15 15 15 15 15 15
DRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
100
90
80
70
60
50
40
30
20
10
0
TIME IN DAYS
PR
IMA
RY
PA
TE
NC
Y (
%)
Number at riskGroup: 4
20 19 14 11 11 11 11 5 5 5 5 5 5 5Group: 5
66 57 52 49 49 49 49 22 22 22 22 22 22 22Group: 6
15 6 4 1 1 1 1 0 0 0 0 0 0 0
RUTHERFORD456
Primary Patency
FREEDOM FROM MAJOR AMPUTATIONDRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
105
95
85
75
65
55
45
35
25
15
5
TIME IN DAYS
FR
EE
DO
M F
RO
M M
AJO
R A
MP
UT
AT
ION
(%
)
Number at riskGroup: 4
13 12 10 7 7 7 7 4 4 4 4 4 4 4Group: 5
34 30 28 25 25 25 25 10 10 10 10 10 10 10Group: 6
9 5 3 3 3 3 3 1 1 1 1 1 1 1
RUTHERFORD456
SurvivalDRUG ELUTING INFRAPOPLITEAL STENTS
0 60 120 180 240 300 360 420 480 540 600 660 720 780
100
90
80
70
60
50
40
30
20
10
0
TIME IN DAYS
Su
rviv
al p
rob
abil
ity
(%)
Number at riskGroup: 4
13 12 10 7 7 7 7 4 4 4 4 4 4 4Group: 5
34 30 28 25 25 25 25 10 10 10 10 10 10 10Group: 6
9 5 3 3 3 3 3 1 1 1 1 1 1 1
RUTHERFORD456
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