599550

research-article2015
JETXXX10.1177/1526602815599550Journal of Endovascular TherapyGarcia et al

Clinical Investigation

Journal of Endovascular Therapy

A Comparison of Clinical Outcomes for

2015, Vol. 22(5) 701­–711
© The Author(s) 2015
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DOI: 10.1177/1526602815599550

Following Directional Atherectomy in the www.jevt.org

DEFINITIVE LE Claudicant Cohort

Lawrence A. Garcia, MD1, Michael R. Jaff, DO2, Krishna J. Rocha-Singh, MD3,

Thomas Zeller, MD4, Christopher Bosarge, MD5, Suraj Kamat, MD6,
and James F. McKinsey, MD7

Abstract
Purpose: To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery
disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants.
Methods: DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy
using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and
infrapopliteal arteries. Of the 800 patients enrolled in the study, only the 598 claudicant patients (mean age 69.5±10.4
years; 336 men) who were classified at baseline as Rutherford category 1–3 were eligible for this subset analysis. Of these,
46.8% (280/598) had diabetes. Follow-up to 12 months included duplex ultrasound examination, functional assessments,
and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary
patency and secondary endpoints; a clinical events committee adjudicated adverse events. Results: Although diabetics had
significantly more baseline comorbidities, 12-month primary patency (77.0%) was no different than for nondiabetics (77.9%;
superiority p=0.98; noninferiority p<0.001) across all anatomic territories treated. Freedom from clinically driven target
lesion revascularization was no different between diabetics (83.8%) and nondiabetics (87.5%) overall (p=0.19) or by lesion
locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved
at 12 months for both diabetics and nondiabetics. Conclusion: Noninferior 12-month patency rates demonstrate that
directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants. Directional atherectomy
remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment
options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease.

Keywords
atherectomy, claudication, diabetes mellitus, directional atherectomy, infrapopliteal arteries, patency, peripheral artery
disease, popliteal artery, superficial femoral artery, target lesion revascularization

Introduction
Diabetes mellitus is a growing global epidemic, afflicting
371 million people today and as many as 552 million by
2030.1,2 Diabetes is one of the most prevalent risk factors
for peripheral artery disease (PAD), which affects 1 out of 3
diabetics over the age of 50.3,4 If left untreated, PAD can
result in a myriad of complications from lifestyle-limiting
intermittent claudication to ischemic rest pain and may
eventually lead to limb loss.5
A diagnosis of diabetes mellitus has historically been a
principal risk factor for the development of both coronary
and peripheral vascular disease.6,7 Diabetic patients generally
1
Sections of Interventional Cardiology and Vascular Medicine, St.
Elizabeth’s Medical Center, Tufts University School of Medicine, Boston,
MA, USA
2
The Institute for Heart, Vascular and Stroke Care, Massachusetts
General Hospital, Boston, MA, USA
3
The Prairie Heart Institute at St. John’s Hospital, Springfield, IL, USA
4
Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany
5
Coastal Vascular and Interventional, Pensacola, FL, USA
6
Christus Spohn Hospital Alice, Alice, TX, USA
7
Division of Vascular Surgery, New York Presbyterian Hospital,
University Hospital of Columbia and Cornell, New York, NY, USA
Corresponding Author:
Lawrence A. Garcia, Section of Interventional Cardiology, St. Elizabeth’s
Medical Center, 736 Cambridge Street, Boston, MA 02135 USA.
Email: Lawrence.garcia@steward.org
702 Journal of Endovascular Therapy 22(5)
have more advanced arterial disease that affects the small and
medium sized arteries of the lower limb.8 Patients with diabe-
tes have an increased risk of mortality and limb loss in both
short-term and longer-term follow-up.9–11
Treatment strategies for PAD include medical therapy as
well as more invasive strategies, such as endovascular ther-
apies (angioplasty, stent, or atherectomy) or surgical bypass,
each with their inherent risks and benefits.5 While mini-
mally invasive treatments are appealing to many patients
with PAD, previous studies have shown endovascular treat-
ment of PAD to be less durable in diabetics compared to
nondiabetics.12,13
The DEFINITIVE LE study [Determination of
Effectiveness of the SilverHawk/TurboHawk Peripheral
Plaque Excision Systems (SilverHawk/TurboHawk
devices) for the Treatment of Infrainguinal Vessels/Lower
Extremities] was a multinational, multicenter, prospective
registry evaluating the effectiveness and durability of direc-
tional atherectomy for the treatment of patients with claudi-
cation and critical limb ischemia (CLI).14 A prospective
substudy was designed and powered to compare outcomes
in the subset of patients with claudication based on diabetic
status, evaluating the prespecified hypothesis that direc-
tional atherectomy treatment of diabetic claudicant patients
has noninferior 12-month primary patency compared with
nondiabetic claudicant patients from the DEFINITIVE LE
trial cohort. The aim of this report is to present the results of
this substudy, including primary patency, target lesion
revascularization (TLR), periprocedural adverse events,
and functional outcomes following primary treatment with
directional atherectomy stratified by diabetic status.
Methods
Study Design
Details of the DEFINITIVE LE study have been previously
reported14 but are briefly described here. The institutional
review board or ethics committee at each of the 47 partici-
pating sites approved the study protocol. Of the 800 patients
enrolled in the study, only the claudicant patients who were
classified at baseline as Rutherford category (RC) 1–315
were eligible for this subset analysis. Patients with CLI,
severely calcified lesions, in-stent restenosis, or end-stage
renal disease were excluded. Diabetic status was analyzed
according to each patient’s site-reported medical history
and further characterized by the method of control (eg,
insulin dependent, oral agents) and hemoglobin A1c level.
Multiple target lesions, each individually up to 20 cm in
total length, regardless of location [superficial femoral
artery (SFA), popliteal, or infrapopliteal], were allowed.
Lesion location was classified according to the most proxi-
mal diseased segment (ie, a lesion extending from the SFA
to the popliteal artery was classified as SFA). Infrapopliteal
revascularization interventions were left to the discretion of
the operator. If a single outflow (tibial) vessel required ther-
apy, then directional atherectomy was the treatment man-
dated. If, however, multiple outflow vessels required
treatment, then the intervention modality was left to the dis-
cretion of the operator.
All patients underwent percutaneous revascularization
of target lesions using the SilverHawk/TurboHawk Plaque
Excision System (Covidien, Mansfield, MA, USA). The
goal of therapy was to achieve <30% residual stenosis with
directional atherectomy as the sole therapy. If this was not
obtained, then adjunctive therapy with balloon dilation was
allowed per the protocol to treat major flow-limiting dissec-
tion (grade D or greater), perforations, occlusive complica-
tions (ie, recoil), or residual stenosis. Stenting was
discouraged within the trial but could be performed for
flow-limiting dissections, perforations, recoil, or residual
stenosis >30% after balloon dilation.
Follow-up visits occurred at 30 days, 6 months, and 12
months after the procedure. Each visit included duplex
ultrasound examination of the target lesion site(s), assess-
ment of the RC score, the Walking Impairment Questionnaire
(WIQ),16 EuroQOL 5 Domains (EQ-5D),17 the ankle-bra-
chial index (ABI), and adverse event evaluations. A clinical
events committee (CEC) of independent physicians adjudi-
cated adverse events and study outcomes. Independent core
laboratories analyzed and adjudicated angiographic images
of all pre- and postatherectomy target lesions (SynvaCor,
Springfield, IL, USA); duplex ultrasound images were ana-
lyzed by VasCore (Massachusetts General Hospital, Boston,
MA, USA).
Patient Population
Between April 2009 and April 2011, 598 claudicant patients
(mean age 69.5±10.4 years; 336 men) were enrolled in the
DEFINITIVE LE study at 45 centers. Of these, 46.8%
(280/598) had diabetes, including 4.2% (25/598) type I and
42.5% (254/598) type II (type of diabetes not reported for
one insulin-dependent patient). Baseline patient character-
istics by diabetic status are reported in Table 1; lesion char-
acteristics are presented in Table 2.
Endpoints
The primary endpoint for patients with claudication (RC
1–3) was primary patency at 12 months defined by duplex
ultrasonography assessment of the peak systolic velocity
ratio (PSVR) at the target lesion(s) with no clinically driven
reintervention within the target segment. Reinterventions
were at the discretion of the investigator; however, the CEC
adjudicated “clinically-driven revascularization” as ≥50%
diameter stenosis in the presence of recurrent symptoms or
an asymptomatic ≥70% stenosis in the treated segment. The
Garcia et al 703

Table 1.  Baseline Patient Characteristics by Diabetic Status.

Patient Characteristics Diabeticsa (n=280) Nondiabeticsa (n=318) p

Age, y 67.6±9.7 71.1±10.8 <0.001
Women 116/280 (41.4) 146/318 (45.9) 0.28
Race/ethnicity <0.001
 Caucasian 177/280 (63.2) 252/318 (79.2)  
  African American 64/280 (22.8) 46/318 (14.5)  
 Hispanic 38/280 (13.6) 18/318 (5.7)  
 Other 1/280 (0.4) 2/318 (0.6)  
Hemoglobin A1c, % 7.7±1.9 (242/280) 5.8±0.9 (279/318) <0.001
  7.3 [6.3–8.3] 5.7 [5.5–6.0]  
Method of diabetes control
  Oral agents (without insulin) 141/280 (50.4)  
  Insulin dependent (no oral agent) 84/280 (30.0)  
  Oral agents and insulin 39/280 (13.9)  
  Diet and exercise only 11/280 (3.9)  
  Other only 5/280 (1.8)  
History and risk factors
 Angina 73/280 (26.1) 64/318 (20.1) 0.10
 Arrhythmia 39/280 (13.9) 54/318 (17.0) 0.31
  Congestive heart failure 52/280 (18.6) 27/318 (8.5) <0.001
  Coronary artery disease 128/280 (45.7) 114/318 (35.8) 0.02
 Stroke 32/280 (11.4) 22/318 (6.9) 0.06
  Transient ischemic attack 19/280 (6.8) 24/318 (7.5) 0.75
  Myocardial Infarction 64/279 (22.9) 47/318 (14.8) 0.01
  CABG or PCI 133/280 (47.5) 103/318 (32.4) <0.001
 Hypertension 266/280 (95.0) 284/318 (89.3) 0.01
 Hyperlipidemia 247/280 (88.2) 268/318 (84.3) 0.19
  Renal insufficiency 64/280 (22.9) 36/318 (11.3) <0.001
  Nonhealing ischemic ulcers 7/280 (2.5) 5/318 (1.6) 0.56
  Tobacco use 0.012
   Never or not in past 10 years 148/280 (52.9) 130/318 (40.9)  
   Not a current smoker 60/280 (21.4) 71/318 (22.3)  
   Current, <1 pack/d 39/280 (13.9) 57/318 (17.9)  
  Current, ≥1 pack/d 33/280 (11.8) 60/318 (18.9)  

Abbreviations: CABG, coronary artery bypass grafting; PCI, percutaneous coronary intervention.
a
Continuous data are presented as the means ± standard deviation (number/sample if less than n) and/or median [interquartile range]; categorical data
are given as the counts/sample (percentage).

study protocol defined primary patency with both a PSVR
cutoff of 3.5 (primary endpoint) and 2.4 (secondary end-
point). While PSVR ≤3.5 was prespecified as the primary
endpoint because it represented critical stenosis with clini-
cal effects, patency defined as PSVR ≤2.4 has been clini-
cally established as the more appropriate value to detect
restenosis and is frequently used for reporting in interven-
tional studies.18–20 Therefore, PSVR ≤2.4 was used as the
definition for patency rates in this report.
Secondary endpoints included device success, defined as
≤30% residual stenosis following directional atherectomy
without adjunctive endovascular interventions or periproce-
dural complications as assessed by the angiographic core
laboratory, and procedure success, defined as ≤30% residual
stenosis following directional atherectomy and adjunctive
endovascular interventions (if required), as assessed by the
core laboratory, without periprocedural complications.
Improvements in functional outcomes, including RC, ABI,
EQ-5D, and WIQ, were evaluated between baseline and 12
months.
Statistical Analysis
The study was prospectively powered to test the hypothesis
that claudicants with diabetes would have noninferior pri-
mary patency at 12 months compared to patients without
diabetes when treated with directional atherectomy. In
DEFINITIVE LE, the sample size required to evaluate the
hypothesis of noninferior patency in diabetic vs nondiabetic
claudicants with 80% power was statistically derived with a
704 Journal of Endovascular Therapy 22(5)

Table 2.  Lesion Characteristics by Diabetic Status.

Lesion Characteristics Diabeticsa (n=345) Nondiabetics (n=398) p

Target artery 0.15
 SFA 241/345 (69.8) 295/398 (74.1)  
 Popliteal 52/345 (15.1) 62/398 (15.6)  
 Infrapopliteal 52/345 (15.1) 41/398 (10.3)  
Lesion length, cm 7.6±5.3 7.4±5.3 0.77
Lesions per patient 1.2±0.5 (280/345) 1.3±0.6 (318/398) 0.66
Preprocedure MLD, mmb 1.3±0.9 (343/345) 1.2±0.9 0.17
Baseline stenosis, %b 71.9±17.1 (343/345) 73.4±19.0 0.28
Occlusionsb 45/343 (13.1) 84/398 (21.1) 0.004
Calcificationb 1.0
 No 216/344 (62.8) 251/398 (63.1)  
 Present 117/344 (34.0) 135/398 (33.9)  
 Severe 11/344 (3.2) 12/398 (3.0)  
Restenosis (site assessed) 29/345 (8.4) 19/398 (4.8) 0.05
Target lesion length, cm 0.97
  ≥10.0 99/345 (28.7) 116/398 (29.1)  
 4.0–9.9 145/345 (42.0) 163/398 (41.0)  
 <4 101/345 (29.3) 119/398 (29.9)  
TASCb 0.12
 A 214/344 (62.2) 227/398 (57.0)  
 B 94/344 (27.3) 118/398 (29.7)  
 C 36/344 (10.5) 53/398 (13.3)c  

Abbreviations: MLD, minimum lumen diameter; SFA, superficial femoral artery; TASC, TransAtlantic Inter-Society Consensus.
a
Continuous data are presented as the means ± standard deviation (number/sample if less than n); categorical data are given as the counts/sample
(percentage).
b
Some data points are missing as the quality of the captured procedural images were not analyzable by the core laboratory.
c
Includes 3 TASC D lesions.

1-sided alpha of 0.05 and a noninferiority margin of 12%.
The postulated rate of primary patency at 12 months per
previous experience was 60% in each subgroup, resulting in
a minimum sample size of 424 claudicant patients.21
Noninferiority was tested using Blackwelder’s method.22
Continuous variables were evaluated using the Student t
test and Wilcoxon rank-sum test, categorical variables using
the Fisher exact test, and ordinal variables using the Mantel-
Haenszel chi-square test. All tests were 2-sided; p<0.05 was
deemed the threshold of statistical significance. The pri-
mary endpoints were estimated using Kaplan-Meier time-
to-event methods; group estimates were compared using the
log-rank test. The adverse event incidence was calculated at
12 months after the intervention. All statistical analyses
were performed using SAS for Windows (version 9.1 or
higher; SAS Institute, Inc, Cary, NC, USA).
Results
Group Comparison
Patients with diabetes had significantly higher hemoglobin
A1c values at baseline (median 7.3 vs 5.7; p<0.001). The
method of diabetes control was primarily oral agents
(50.4%; 141/280), followed by insulin injection (30.0%;
84/280), or a combination of both oral agents and insulin
(13.9%; 39/280). Patients in the diabetic cohort were sig-
nificantly younger but had significantly more risk factors,
including congestive heart failure, coronary artery disease,
myocardial infarction, coronary artery bypass graft, hyper-
tension, and renal insufficiency (Table 1). The nondiabetic
cohort of patients had significantly more current heavy
smokers. There were higher percentages of African
American and Hispanic patients in the diabetic cohort. At
the end of 12 months, 81.9% (490/598) of patients com-
pleted the study, 2.2% (13/598) expired, 12.5% (75/598)
withdrew, and 3.3% (20/598) were lost to follow-up.
Lesion characteristics were similar between the diabetic
(345 lesions) and nondiabetic cohorts (398 lesions), with
mean number of lesions per patient of 1.2 and 1.3, respec-
tively (Table 2). Overall, mean lesion length was 7.6 vs 7.4
cm, with 28.7% vs 29.1% of lesions ≥10 cm for diabetic vs
nondiabetic patients across all anatomic territories. Baseline
mean reference vessel diameter was 4.3±1.2 vs 4.3±1.0 mm
(p=0.88) and percent stenosis was 71.9% vs 73.4% (p=0.28)
for diabetics vs nondiabetics. Calcification was present in
34.0% vs 33.9% of lesions for diabetics vs nondiabetics.
Despite the exclusion of site-reported severe calcification,
Garcia et al 705

Table 3.  Procedure Data and Intervention Outcomes by Diabetic Status.

Diabeticsa (n=280) Nondiabeticsa (n=318) p

Procedure data
  Time, minb 69.3±34.4 (278/280) 66.2±32.0 0.28
  Fluoroscopy time, minb 20.7±20.0 (279/280) 19.4±17.6 (313/318) 0.27
  Contrast administered, mLb 160.8±97.5 (279/280) 157.8±93.6 (314/318) 0.86
  Use of embolic protection 59/280 (21.1) 64/318 (20.1) 0.84
  SpiderFX only 57/280 (20.4) 64/318 (20.1) 1.0
  Embolization rate 7/280 (2.5) 8/318 (2.5)  
   With embolic protection 2/59 (3.4) 1/64 (1.6)  
   Without embolic protection 5/221 (2.3) 7/254 (2.8)  
Intervention outcomes 345 lesions 398 lesions  
  Device successb,c 262/334 (78.4) 290/393 (73.8) 0.16
  Postdevice stenosis, %b,c 23.8±12.3 (334/345) 23.9±13.7 (393/398) 0.81
  Procedure success, %b,c 313/341 (91.8) 361/397 (90.9) 0.70
  Postadjunctive stenosis, %c,d 17.8±10.6 (125/345) 18.1±11.4 (153/398) 0.80
a
Continuous data are presented as the means ± standard deviation (number/sample); categorical data are given as the counts/sample (percentage).
b
Missing data were either not reported by the site or not analyzable by the core laboratory.
c
As assessed by the core laboratory.
d
Includes only lesions that had adjunctive therapy after directional atherectomy.

3% of enrolled patients in each group had severe calcification
as assessed by the core laboratory. Patients in the nondiabetic
subgroup had a higher percentage of occlusions (21.1% vs
13.1% for diabetics, p=0.004), whereas the diabetic patients
had more restenotic lesions (8.4% vs 4.8%, respectively;
p=0.05). Lesion location was primarily SFA for both groups
(69.8% vs 74.1% for diabetics vs nondiabetics), with more
target lesions in the infrapopliteal segment for the diabetics
than the nondiabetics (15.1% vs 10.3%, p=0.058).
Procedure Data
Despite differences in patient and lesion characteristics
between groups, procedure data were similar (Table 3). The
use of embolic protection (EP) was 20.1% and 21.1% in the
diabetic and nondiabetic groups and the embolization rate
was low regardless of EP use in both groups. Device success
(defined as ≤30% residual stenosis following directional
atherectomy) was comparable in the diabetic and nondia-
betic groups at 78.4% and 73.8%, respectively (p=0.16).
Similarly, procedure success (which included the use of
adjunctive therapy) was ~91% in both groups. The rates of
adjunctive therapy were 36.5% (126/345) for the diabetic
patients and 39.9% (159/398) for the nondiabetic patients,
with the majority of adjunctive therapies being angioplasty
alone. Stent rates were low in both groups: 3.5% (12/345) of
lesions for diabetics and 3.8% (15/398) for nondiabetics.
Primary Patency and TLR
Primary patency at 12 months, per core laboratory assess-
ment, was 77% for the diabetic subset and 78% for the
nondiabetic subset (p=0.98). The prespecified noninferiority
hypothesis of primary patency at 12 months following direc-
tional atherectomy treatment for the diabetic cohort in com-
parison to the nondiabetic cohort was met (noninferiority
p<0.001). No significant differences in 12-month primary
patency were seen among the target lesion locations (Table 4),
including 74.3% vs 76.4% for SFA lesions and 74.5% vs
79.2% for popliteal lesions in the diabetic vs. nondiabetic
groups. Among the SFA lesions, diabetics with TASC C
lesions (mean length 17.0 cm; n=33) had 78.9% primary
patency at 12 months in comparison to 64.3% for nondiabet-
ics (mean length 16.0 cm; n=49), although the difference was
not statistically significant. For the infrapopliteal lesions, the
diabetic group had a longer infrapopliteal mean lesion length
(6.0 cm; n=52) than the nondiabetic group (4.8 cm; n=41),
and the primary patency rates were similar at 91.5% and
87.2% for diabetics and nondiabetics, respectively. While
more occluded lesions were treated in the nondiabetic group,
patency at 12 months for these lesions in the diabetic patients
were not different than the nondiabetics (72.2% vs 58.9%;
p=0.28). Although the numbers were small, this difference
was driven primarily from the 84.2% primary patency in the
occluded SFA lesions in the diabetic group vs only 56.6% in
the nondiabetic group. In order to assess the impact of the SFA
occlusions on the overall patency results, a sensitivity analysis
was conducted. Without the SFA occlusions, the 12-month
patency rates were not significantly different at 76.3% for the
diabetics and 82.9% for the nondiabetic patients (p=0.14).
Within the cohort of diabetic patients, a statistically sig-
nificant difference in 12-month patency by method of dia-
betic control was seen: 68.4% for 84 patients (103 lesions)
on insulin, 80.0% for 141 patients (178 lesions) on oral
706 Journal of Endovascular Therapy 22(5)

Table 4.  Kaplan-Meier Primary Patency Estimates at 12 Months Stratified by Diabetic Status and Hemoglobin A1c.

Diabetics Nondiabetics

Patients, Mean K-M Patients, Mean K-M

Subgroup Lesions Length, cma Estimate, % Lesions Length, cma Estimate, % p
All claudicants 280, 345 7.6 77.0 318, 398 7.4 77.9 0.98
SFA 215, 241 8.2 74.3 260, 295 8.1 76.4 0.87
  TASC A 131, 140 4.8 76.0 143, 155 4.4 82.2 0.38
  TASC B 62, 68 10.8 68.8 79, 91 10.2 71.7 0.70
  TASC C 29, 33 17.0 78.9 42, 49b 16.0 64.3 0.46
Popliteal 49, 52 6.1 74.5 61, 62 5.9 79.2 0.38
Infrapopliteal 44, 52 6.0 91.5 31, 41 4.8 87.2 0.31
Nonoccludedc 243, 298 7.0 77.5 246, 314 6.5 83.4 0.20
Occludedc 44, 45 11.5 72.2 83, 84 11.0 58.9 0.28
 SFA 31, 31 12.5 84.2 68, 68 11.6 56.6 —
 Popliteal 10, 11 8.4 53.0 13, 13 8.9 66.7 —
 Infrapopliteal 3, 3 12.3 33.3 3, 3 6.0 100 —

Hgb A1c 4%–5.6% Hgb A1c 5.7%–6.4% Hgb A1c 6.5%+

Patients, Mean K-M Patients, Mean K-M Patients, Mean K-M

Subgroup Lesions Length, cma Estimate, % Lesions Length, cma Estimate, % Lesions Length, cma Estimate, % p
All claudicants 125, 154 7.6 78.6 200, 242 7.9 76.9 196, 240 7.6 77.4 0.74
SFA 97, 115 8.0 80.0 164, 178 8.8 74.8 150, 162 8.2 72.3 0.53
Popliteal 22, 24 7.0 71.7 42, 43 5.6 80.0 32, 33 6.3 80.7 0.91
Infrapopliteal 13, 15 5.7 81.8 18, 21 4.7 88.1 35, 45 6.3 92.4 0.47

Abbreviations: Hgb, hemoglobin; K-M, Kaplan-Meier; SFA, superficial femoral artery; TASC, TransAtlantic Inter-Society Consensus.
a
Per core laboratory assessment.
b
Includes 3 TASC D lesions.
c
Baseline occlusion status was missing for 2 diabetic patients.

Table 5.  Kaplan-Meier Freedom From Clinically Driven Target Lesion Revascularization at 12 Months.

Diabetics Nondiabetics

Subgroup Patients, Lesions K-M Estimate, % Patients, Lesions K-M Estimate, % p

All claudicants 280, 345 83.8 318, 398 87.5 0.19
SFA 215, 241 82.7 260, 295 87.9 0.08
  TASC A 131, 140 84.6 143, 155 90.4 0.14
  TASC B 62, 68 78.0 79, 91 88.2 0.09
  TASC C 29, 33 84.4 42, 49a 78.4 0.84
Popliteal 49, 52 78.6 61, 62 79.2 0.93
Infrapopliteal 44, 52 94.1 31, 41 97.3 0.89

Abbreviations: K-M, Kaplan-Meier; SFA, superficial femoral artery; TASC, TransAtlantic Inter-Society Consensus.
a
Includes 3 patients with TASC D lesions.

agents, and 87.6% for 39 patients (47 lesions) on both oral
agents and insulin (p=0.01). Based on hemoglobin A1c lev-
els, there were no differences in the patency across all ana-
tomic locations evaluated (Table 4).
Similarly, there were no significant differences in free-
dom from clinically-driven TLR between diabetic and non-
diabetic subgroups, with rates of 83.8% vs 87.5%,
respectively (p=0.19; Table 5). Comparable to primary
patency, this was observed across all lesion locations with
82.7% vs 87.9% for SFA, 78.6% vs 79.2% for popliteal, and
94.1% vs 97.3% for infrapopliteal lesions for diabetic vs
nondiabetic patients, respectively. Within 12 months, 47
diabetic patients developed 51 lesions, while 45 lesions
were identified in 44 nondiabetic patients. Overall, only 33
(34.4%) of the 96 revascularized lesions received a stent.
The most common treatments were atherectomy in 59
Garcia et al 707

Table 6.  Events Within 30 Days.

Event Typea Diabeticsb (n=280) Nondiabeticsb (n=318)

Patients with at least 1 event 29 (10.4) 35 (11.0)
Distal embolization 7 (2.5) 8 (2.5)
  PTA required 4 (1.4) 2 (0.6)
  Stenting required 1 (0.4) 0 (0.0)
  No intervention required 2 (0.7) 6 (1.9)
Abrupt closure 3 (1.1) 1 (0.3)
  Surgery required 2 (0.7) 1 (0.3)
  No intervention required 1 (0.4) 0 (0.0)
Dissection (flow-limiting) 7 (2.5) 6 (1.9)
  PTA required 3 (1.1) 1(0.3)
  Stenting required 1 (0.4) 3 (0.9)
  No intervention required 3 (1.1) 2 (0.6)
Perforation 16 (5.7) 21 (6.6)
  PTA required 8 (2.9) 7 (2.2)
  Stenting required 4 (1.4) 10 (3.1)
  Surgery required 1 (0.4) 0 (0.0)
  No intervention required 3 (1.1) 4 (1.3)
Aneurysm 1 (0.4) 2 (0.6)
  Stenting required 0 (0.0) 2 (0.6)
  No intervention required 1 (0.4) 0 (0.0)

Abbreviations: PTA, percutaneous transluminal angioplasty.

a
Includes events occurring from the index procedure to 30 days postprocedure.
b
Data are presented as the count (percentage). Patients may have more than 1 event type and may appear in multiple rows, thus the sum of the rows
need not add to the overall event rate.

(61.5%) lesions and angioplasty in 47 (49.0%) lesions, with Functional Outcomes

some lesions receiving more than one treatment.
Adverse Events
All periprocedural events were reported by the investigator
and adjudicated by the angiographic core laboratory or the
CEC. Of the 90 patients in the overall DEFINITIVE LE
study experiencing an event within 30 days of the proce-
dure, 64 were claudicants (29 diabetic and 35 nondiabetic;
Table 6). Fifty-five of 64 patients experienced events during
the index procedure only, which were classified as distal
embolizations, flow-limiting dissections, and perforations.
Perforations from any source were included whether from
directional atherectomy, wire passage, or adjunctive ther-
apy and were the most commonly reported periprocedural
event in each group. Distal embolization was noted in 2.5%
of patients in each group as reported by the investigator or
identified by the angiographic core laboratory. One diabetic
patient had an abrupt closure and one diabetic patient had
an aneurysm during the procedure, neither requiring treat-
ment. Nine patients experienced events within 30 days,
including abrupt closures requiring surgical intervention (2
diabetic and 1 nondiabetic patients), perforations requiring
stenting (1 diabetic and 3 nondiabetic patients), and aneu-
rysms requiring stenting in 2 nondiabetic patients.
Baseline and 12-month functional assessments, including
RC, ABI, EQ-5D, and WIQ, were similar between the dia-
betic and nondiabetic subgroups (Table 7). The majority of
patients, 79.9% of diabetics and 86.2% of nondiabetic clau-
dicants, improved at least one Rutherford category between
baseline and 12 months, while 7 (3.1%) diabetic patients
progressed to CLI (RC 4 or 5) compared with 4 (1.5%) non-
diabetic patients. The mean baseline ABI was 0.7 in both
groups and 0.8 at 12 months in the diabetic group and 0.9 in
the nondiabetic group. In both groups, ~76% of patients had
an improvement in their ABI at 12 months. In the diabetic
group, 65.4% (151/231) had improved EQ-5D scores at 12
months compared with 62.6% (159/254) in the nondiabetic
group. Similarly, 73.1% (160/219) and 80.9% (195/241) of
diabetic and nondiabetic patients, respectively, had an
increase in their walking distance score (Figure 1).
Discussion
Diabetic patients have historically posed greater challenges
for endovascular and open surgical techniques for both coro-
nary artery disease and PAD.12,13,23–27 The difficulties have
been driven by numerous factors, including more diffuse ath-
erosclerotic disease causing longer lesions with smaller diam-
eter lumens, more calcification, and greater atherosclerotic
708 Journal of Endovascular Therapy 22(5)

Table 7.  Functional Outcomes by Diabetic Status.

Diabeticsa Nondiabeticsa

Functional Assessment Baseline (n=280) 12 Months (n=229) Baseline (n=318) 12 Months (n=254)
b
Rutherford category
  0 Asymptomatic 0 (0.0) 86 (37.6) 0 (0.0) 113 (44.5)
  1 Mild claudication 13 (4.6) 65 (28.4) 15 (4.7) 80 (31.5)
  2 Moderate claudication 79 (28.2) 42 (18.3) 93 (29.2) 35 (13.8)
  3 Severe claudication 188 (67.1) 29 (12.7) 210 (66.0) 22 (8.7)
  4 Ischemic rest pain 0 (0.0) 5 (2.2) 0 (0.0) 3 (1.2)
  5 Minor tissue loss 0 (0.0) 2 (0.9) 0 (0.0) 1 (0.4)
ABIc 0.7±0.2 (252) 0.8±0.2 (212) 0.7±0.2 (288) 0.9±0.2 (242)
EQ-5D indexd 0.7±0.2 (279) 0.8±0.2 (231) 0.8±0.2 (317) 0.8±0.2

Abbreviations: ABI, ankle-brachial index; EQ-5D, EuroQOL 5 Domains.

a
Continuous data are presented as the means ± standard deviation (number if less than n); categorical data are given as the counts (percentage).
b
No significant differences (p>0.20) at baseline and 12 months for diabetics vs nondiabetics (Fisher exact test).
c
84 diabetics and 94 nondiabetics had noncompressible arteries at baseline or 12 months; no significant differences (p>0.20) at baseline and 12 months
(Wilcoxon rank-sum test).
d
Significant differences (p<0.05) at both baseline and 12 months for diabetics vs nondiabetics (Wilcoxon rank-sum test).

Figure 1.  All mean Walking Impairment Questionnaire scores (walking distance, walking speed, and stair climbing) significantly
improved from baseline to 12 months for both diabetic and nondiabetic patients (p<0.001).

disease burden.5 The DEFINITIVE LE registry was prospec-
tively powered to evaluate outcomes of directional atherec-
tomy for patients with lower limb claudication who also have
diabetes in comparison to those without. With nearly half of
the study sample having diabetes, this robust cohort demon-
strated the equipoise of treatment using directional atherec-
tomy between patients with and without diabetes. Indeed,
similar patency outcomes were also noted for those anatomic
locations with lesions above and below the knee joint space.
The mechanism of benefit from directional atherectomy in
both diabetic and nondiabetic patients may be driven by
enlargement of luminal diameter, with or without adjunctive
angioplasty, as well as the absence of an endoprosthesis,
which may lead to an improved response to injury following
intervention.
These findings are distinct from previously reported
studies of diabetics and nondiabetics.12,13,28 In the study by
Abularrage et al,28 after controlling for disease severity, dia-
betes was an independent risk factor (hazard ratio 1.25,
95% CI 1.01 to 1.54, p<0.04) for reduced primary patency
out to 5 years in a study of 920 patients treated with balloon
dilation and stenting in comparison to the nondiabetic
patients. Furthermore, Sabeti et al13 showed that 1-year out-
comes for the longer SFA lesions were better in nondiabetic
(71%) compared with diabetic patients (22%).
More recently, the Zilver PTX study reported that the
diabetic and nondiabetic cohorts in their registry had simi-
lar outcomes using the paclitaxel-eluting stent platform.29
However, this was a post hoc retrospective analysis for the
Zilver PTX, whereas the DEFINITIVE LE study was a
Garcia et al 709
prespecified and statistically powered prospective analysis.
This study underscores the demonstrated patency similarity
across several anatomic locations using directional atherec-
tomy in patients with and without diabetes.
Additionally, the outcomes of drug-coated balloon
(DCB) technology in the recently published LEVANT I
(treating only SFA and popliteal lesions) and DEBELLUM
(with 62% claudicants and 38% CLI patients) studies
revealed improved patency at 12 months compared with
bare balloon technology, with 12-month patency rates in
the DCB arms of 67% and 76%, respectively.19,30 These
DCB outcomes, for populations with similar diabetic status
(45% and 44%, respectively) as the DEFINITIVE LE clau-
dicant cohort, are similar to those achieved in this direc-
tional atherectomy study, with 12-month primary patency
rates of 77% and 78% in the diabetic and nondiabetic
cohorts, respectively. However, these directional atherec-
tomy outcomes were achieved without stenting in the
DEFINITIVE LE study, which had a much lower stent rate
(3%) than the DCB studies (27% in LEVANT I19 and 35%
in DEBELLUM30).
This study has demonstrated that initial therapy with
directional atherectomy for patients with or without diabe-
tes has similar outcomes in primary patency at 12 months.
The overall outcome in the SFA of 74.3% for diabetics and
76.4% for nondiabetics is noteworthy, particularly given the
low stenting rate. Furthermore, when the patency rates for
SFA lesions were evaluated by TASC classification,31 simi-
lar (types A/B) or better (types C/D) primary patency was
found for diabetic vs nondiabetic patients, though some
groups had small numbers.
Unlike other trials to date, DEFINITIVE LE has shown
that primary patency for lesions in the popliteal artery and
the infrapopliteal vessels were also similar for diabetic and
nondiabetic patients, confirming that directional atherec-
tomy using the SilverHawk/TurboHawk system achieves
similar 12-month patency across all anatomic locations
with a very low rate of stenting, suggesting that a leave-
nothing-behind strategy is an additional option in the treat-
ment armamentarium for our patients with claudication.
This finding is particularly significant as the diabetic
patients in this cohort had more comorbidities than the non-
diabetic patients and the primary patency achieved across
both groups has not been previously reported in a prospec-
tive study.
Furthermore, the lesions treated in diabetics were more
often restenotic compared with the nondiabetic population,
while the nondiabetics had a higher number of occlusive
lesions treated, and yet each group had similar patency at
the end of 12 months. These 2 issues are not mutually exclu-
sive but demonstrate the issue of diffuse or recurrent dis-
ease in the diabetic patients. Alternatively, in the nondiabetic
patients, the higher number of SFA occlusions translated
into a lower primary patency rate (57%) compared with a
similar group with diabetes (84%), albeit the numbers of
occlusive lesions were small (68 in nondiabetics and 31 in
diabetics). An ad hoc sensitivity analysis excluding the SFA
occlusions revealed that similar 12-month primary patency
rates for diabetics and nondiabetic was not driven solely by
the results in the SFA occlusions. Despite these differences
in occlusive and restenotic lesions, the overall outcome of
primary patency similarity between the 2 groups is compel-
ling across the entire anatomic distribution and across lesion
types, but clearly a larger sample size of any one territory or
type of lesion would be useful for direct comparisons. It
should be noted that the overall occlusion rates reported in
this study are relatively low at 13% for diabetics and 21%
for nondiabetic patients, which reflects the inherent biases
in nonrandomized data. It remains unclear from this study
why the patients treated with insulin alone did worse in
comparison to those on oral agents and insulin combination
therapy. Confounders or chance could play a role with these
specific findings.
Overall, a distal EP device was used in a fifth of the
cases. The non-EP patients did not have a higher level of
emboli either in the diabetic or nondiabetic populations.
Furthermore, the most likely complication with atherec-
tomy in this study was perforation (~6%), but these events
included perforations that occurred at any time during the
procedure and were not necessarily related to the device.
However, perforations do occur more often with a debulk-
ing strategy and should not be minimized. In the context of
complications, it remains important to know the goal of
therapy and whether the benefits of achieving <30% resid-
ual stenosis outweigh the risk of complications during fur-
ther debulking in a recalcitrant or resistant lesion.
Several key points to this trial, as well as limitations,
should be addressed. First, the outcomes of DEFINITIVE
LE have shown benefits out to 12 months, with low compli-
cation rates for claudicant patients who are either diabetic
or not. However, these results should not suggest a “class
effect” to other atherectomy devices. Critically, the
SilverHawk device is unique as it uses neither rotation nor
energy for kinetic ablation of plaque, so this trial is specific
to the SilverHawk and TurboHawk devices. These out-
comes should not be inferred comparable to or be expected
with another atherectomy device, either one already
approved or in the process of being approved for peripheral
vascular interventions.
Second, the mean 7-cm lesion lengths were averages that
included all lesions, and all lesions were not confined to one
anatomic location or vessel as with other trials. DEFINITIVE
LE has a unique opportunity to describe patency rates across
several anatomic locations in the lower limb.
Third, the registry format for DEFINITIVE LE brings
the limitations of such a study design in comparison to a
randomized clinical trial. This limitation is critical to under-
standing the dataset and its place in the scientific landscape.
710 Journal of Endovascular Therapy 22(5)
However, a CEC of independent physicians adjudicated the
outcomes of this robust trial, and core laboratories analyzed
both the angiographic and sonographic outcomes reported
here. This is significant because core laboratory–reported
percent diameter stenosis has been shown to be lower prein-
tervention and higher postintervention than site-reported
values, and primary patency rates are likely impacted as
well.32,33 Furthermore, the prespecification and statistical
power of the diabetic analysis is unique to DEFINITIVE
LE. Therefore, this study provides significant evidence for
this difficult-to-treat diabetic population. Critically,
DEFINITIVE LE has reinforced the continued need for
direct comparative trials necessary to evaluate the benefits
and risks to diabetic patients between different devices used
for lower extremity revascularization.
Conclusion
The DEFINITIVE LE study has demonstrated that direc-
tional atherectomy is equally effective in the treatment of
diabetic and nondiabetic claudicant patients. Directional
atherectomy remains an attractive treatment option because
it removes plaque, improves luminal diameters, and leaves
nothing behind, preserving future treatment options for this
medically complex population with progressive, diffuse
vascular disease.
Acknowledgments
The authors would like to acknowledge Scott Brown, PhD, Sarah
Verdoliva, MS, and Haiying Lin, MS, for statistical support, and
Nancy Crawford-Zendner, BSN, and Christine Eickhoff, MS, for
assistance with technical aspects of the article.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest
with respect to the research, authorship, and/or publication of this
article: Lawrence A. Garcia is a paid consultant for Covidien,
Boston Scientific, Angiosculpt, and Pathway/MedRad; he has
received research support from iDev, Covidien, and TriReme, and
he is an equity shareholder in Arsenal, Primacea, TissueGen, CV
Ingenuity, and Scion Cardiovascular. Thomas Zeller has received
consulting fee/honoraria from C.R. Bard, J&J Cordis, Covidien,
Boston Scientific, Straub Medical, Biotronik, W.L. Gore &
Associates, Abbott Vascular; he is on the advisory boards for
Medtronic, W.L. Gore & Associates, Boston Scientific, and he has
received research grants from Veryan, Trireme, Cook, Abbott
Vascular, J&J Cordis, Angioslide, Biotronik, InnoRa, W.L. Gore
& Associates, Covidien, Medtronic, 480 Biomedical, and Volcano.
James F. McKinsey has received consulting fees/honoraria from
Covidien and has received educational grants from Covidien; he
receives limited financial compensation as a SAB member for
Spectranetics. He is also a Co-National PI for Atheromed. Michael
R. Jaff is a noncompensated advisor for Covidien, Abbott
Vascular, Cordis Corporation, Medtronic Vascular, and Boston
Scientific; he is an equity shareholder in PQ Bypass and a board
member of CBSET and VIVA Physicians [a 501(c)(3) not-for-
profit education and research organization]. Krishna J. Rocha-
Singh is a paid consultant for Covidien and Cardiovascular
Systems, Inc., and a board member of VIVA Physicians [a 501(c)
(3) not-for-profit education and research organization].
Funding
The author(s) report receiving the following financial support for
the research, authorship, and/or publication of this article:
Research funded by Covidien, Mansfield, MA, USA.
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