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