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19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
10
12months: In the stent
group the following
SF-36 domains
improved: Physical
Function, 19 points
(p<.001); Bodily Pain,
14 points (p=.001);
General Health, 6 points
(p=.019); Vitality, 10
points (p=.004);
Physical Component
Summary, 6.5 points
(p<.001); EQ5D, 0.14
points (p=.008); and
WIQ 22 points
(p<.001). They were
unchanged in the control
group.
Walking distance (WD)
(from 171±90 to
613±381m, p<.001,
in the stent group and
from 209±106 to
335±321m, p=.012,
in the control group)
improved.
Signicantly better
SF-36 Physical
Component Summary
(p=0.024) and physical
domain scores such as
Physical Function
(p=0.012), Bodily Pain
(p=0.002), General
Health (p=0.037), and
EQ5D (p=0.010) were
reported in intergroup
comparison between the
stent and the control
group.
Stent group improved
from baseline in SF-36
PCS score, Physical
ABI and walking
distance signicantly
improved from
baseline in both
groups.
SF-36, EQ-5D,
WIQ
24months
Signicantly better
WIQ score in stent
group.
Self-
administered
92% 24months:
381
(continued)
function, Bodily pain
and Vitality.
No improvement from
baseline in control
group.
Yes 12,
BMT, randomised into
Stent (n=48) or control
(n=52) group.
100 IC patients already on
Assessment of the
24-month impact of
primary stenting
with nitinol
self-expanding
stents compared to
best medical
(2018) [9]
treatment (BMT)
alone in patients
with stable IC due
to SFA disease on
health-related
quality of life
(HRQoL).
Six withdrew consent, two
died.
hospitals
2010–2015 Seven Swedish
Well matched groups for
age, sex, smoking habits,
BP, cholesterol, duration of
IC, lesion characteristics
and HRQOL.
Randomised
control trial
Mean age in stent (71),
control (70)
Stent vs. BMT Lindgren et al.
Self-expandable,
nitinol, bare metal
stent
382
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7
Quality
score
ICQ: Declined
(improved) post
procedure and sustained.
VIABAHN improved
from 46.6±20.1
Main ndings related to
HRQOL
(n=72) to 20.8±19.6
(VIABAHN 24.2%
vs. 25.9%; p=0.392)
(n=40). Bare stent
improved from
50.1±18.2 (n=75) to
22.9±21.2 (n=45).
SF-36 (physical
domain): immediate
(VIABAHN 2.6% vs.
improvement post
procedure and sustained.
Rutherford: signicantly
improved from baseline
post procedure, then
sustained throughout
follow-up period.
50.0%)
rates (VIABAHN
79.5% vs. 89.3%;
p=0.304)
mortality or
amputation.
Similar long-term
outcomes in both
groups.
J. K. Tun et al.
HRQOL
instrument(s)
used, Method
ofdelivery,
Completion
rate Key outcomes
Follow-up
period
Yes 36months SF-36, ICQ Primary patency rates
Preop
HRQOL
assessment
supercial femoral artery
148 Symptomatic complex
Cohort size, Study
centre(s) Patient characteristics
Comparing the
long-term outcomes
Study intent/
associated study
disease (TransAtlantic
Inter-Society Consensus I
class C and D lesions,
accompanied by
intermittent claudication or
ischemic rest pain.)
of complex
supercial femoral
artery disease
intervention using
the VIABAHN
endoprosthesis to
Not stated Stent fractures
Bare stent n=76,
VIABAHN n=72
USA
those obtained with
bare nitinol stent
implantation
(VIBRANT Trial)
ICQ: 57% Secondary patency
Similar demographics and
SF-36: 57% No procedure-related
medical history, except
VIABAHN signicantly
older.
(Male 65%, 63%; Mean
age 64, 69; DM 45%, 43%;
Rutherford:
HTN 76%, 88%)
64%
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2013) [28]
Study period,
Study type
Stent vs. Stent Geraghty et al.
Device type, Brand
name (if applicable)
2005–2007 19 centres in
Self-expandable,
ePTFE covered
nitinol stent/bare
nitinol stent
control trial
VIABAHN/- Randomised
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
7
(continued)
QoL measures including
EQ-5D, PAQ, and
changes in the
Rutherford category and
ABI/TBI all
demonstrated
improvement over
baseline for subjects in
both the study and
control arms of the trial
with no statistically
signicant differences
for any indicators.
participating in the
study demonstrated
sustained Rutherford
category improvement
at 12 and 24months
post procedure.
LifeStent were
similarly effective
(primary patency,
MAE, TLR,
procedure success)
for the treatment of
lesions in the SFA
and PPA.The high
exibility and zero
fracture rate
associated with the
TIGRIS stent make
this device favourable
for use in
high-exion arteries.
383
Yes 24months EQ-5D, PAQ The TIGRIS stent and
assigned in a 3:1 ratio to
treatment with the TIGRIS
stent (n=197; mean age
66.7±9.28years; 141
men) or LifeStent (n=70;
mean age
67.9±8.87years; 49 men).
274 Subjects were randomly
To evaluate the
safety and
effectiveness of the
TIGRIS stent for
lesions up to 24cm
in the supercial
femoral and
proximal popliteal
arteries (SFA/PPA).
Not stated >85% of patients
Both groups had >85%
current or former smokers
and other comorbidities
typical of a PAD
population. There were
more non-whites in the
study group.
(Europe, USA)
Rutherford:
73%
EQ-5D: 74%
PAQ: 73%
For both groups, 44% of
lesions were located in the
distal SFA or proximal
PPA.Both groups also had
~40% occlusions and 50%
moderately or severely
calcied lesions.
Rutherford
2/3/4=32%/64%/4%
(TIGRIS); 31%/61%/8%
(LifeStent)
(2018) [29]
Stent vs. stent Laird et al.
2012–2014 36 centres
Self-expandable
nitinol stent
interconnected
with PTFE/
Self-expandable,
bare nitinol stent
control trial
TIGRIS/LifeStent Randomised
384
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J. K. Tun et al.
HRQOL
instrument(s)
used, Method
5
Quality
score
The mean pre- and
post-intervention WIQ
Main ndings related to
ofdelivery,
Completion
Follow-up
Preop
HRQOL
scores were 722±1503
HRQOL
treated by
percutaneous nitinol
rate Key outcomes
period
Yes 12months WIQ CFO SFAs can be
assessment
and 8421±5741
(p<0.0005),
respectively. The mean
delta-WIQ was 7405
(95% CI: 6555–9245).
stenting with a high
degree of success
(90.2%) that is
durable at 12-month
follow-up.
target lesion
revascularization rate
was 11.8%.
signicant ABI
93% Patients have
7
VascuQoL score
increased from
improvement.
to be a safe and less
Yes 12months VascuQoL Stent grafting appears
58.6±15.7% of
maximum possible
points to 72.9±18.6%
between baseline
(4.1±1.1 points) and
invasive alternative to
above-knee bypass
surgery, providing
88–92% primary
patency at 12months
the 12-month follow-up
(5.1±1.3 points;
p<.0001)
Clinical success
in long, complex
lesions.
Not stated Target vessel
(improvement of at least
one Rutherford class)
occurred in 90.9% of 99
subjects with known
status at the 12-month
end point.
revascularization,
major amputation, or
death did not occur
through postoperative
30days. No life- or
limb-threatening
97%
intraoperative or
perioperative adverse
events and no acute
limb ischemia cases
were observed during
follow-up.
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
Male 59%
44 (51 limbs) Mean age 70.3 (SD 9.6),
Cohort size, Study
centre(s) Patient characteristics
Reporting the
technical feasibility
and impact on
Study intent/
associated study
Study period,
Study type
Device type, Brand
name (if applicable)
quality of life
(2006) [30]
Stent Dippel et al.
(QOL) for
HTN 84%, DM 39% Not stated Clinically driven
Centre,
angioplasty and
primary stenting of
chronic total
occlusion (CTO) of
the supercial
Not stated Genesis Medical
Self-expandable
bare nitinol stent
Rutherford 2 and 3/4 and
5=88%/12%
All lesions were TASC D
Davenport, Iowa,
USA
femoral artery
(SFA).
cohort
SMART Retrospective
lesions.
female; 97.1% claudicants
103 74.2±7.0years old; 17.5%
The objective of this
study was to assess
1-year safety,
efcacy, and
invasiveness
outcomes of
endovascular stent
(2017) [31]
Stent Ohki et al.
Rutherford 2/3 n=100, 4/5
n=3
Japan
grafting of
symptomatic long
lesions (≥10cm) in
the supercial
femoral artery
(SFA) as a
2012–2013 15 centres in
Self-expandable,
ePTFE covered
nitinol stent with
Hypertension (88.3%),
smoking history (78.6%
overall; 28.2% current
smokers), dyslipidemia
(62.1%), and diabetes
mellitus (60.2%).
substitute for
above-knee open
bypass surgery.
Prospective
study
a Heparin coating
VIABAHN n=100 at 12month
follow-up—two died, one
withdrew consent
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
8
(continued)
Rutherford:
Improvement by at least
1 category in 88.7% of
patients and by 3 levels
in 53.5% of patients at
12months.
SF-12 physical score
and Peripheral Artery
Questionnaire scales
improved signicantly
(p<0.001 for all
comparisons except
treatment satisfaction,
which received a high
rating initially and
throughout). Mean
SF-12 physical score at
12months increased
from baseline by ≈8
points, >3× the
minimum threshold
considered to be
clinically meaningful.
Evaluation at 12months
demonstrated 13–35
point improvement in all
Peripheral Artery
Questionnaire scales;
overall summary score
increased 32 points, 4×
the threshold considered
to be clinically
important.
high primary patency
rate, absence of stent
fracture, and
signicant
improvements in
functional and
quality-of-life
measures, the Supera
stent provides safe
and effective
treatment of
femoropopliteal
lesions in
symptomatic patients
with peripheral artery
disease.
385
Not stated At 6 and 12months,
Yes 12months SF-12, PAQ On the basis of the
artery disease (lifestyle
limiting intermittent
claudication or ischemic
rest pain (Rutherford–
Becker scale 2–4))
undergoing percutaneous
treatment of de novo or
264 Symptomatic peripheral
Wire-Interwoven
Nitinol Stent
Outcome in the
Supercial Femoral
USA
and Proximal
Popliteal Arteries
12-month Results of
the SUPERB Trial
Rutherford:
87%
restenotic lesions of the
supercial femoral or
proximal popliteal
(femoropopliteal) artery.
Mean (±SD) age was 68.7
(±10.0) years; 63.6% were
males
PAQ-Physical
limitation: 78%
PAQ-Social
HTN 95%, DM 44% SF-12: 87%
Rutherford
2/3/4=38%/57%/5%
Proximal/Middle/Distal
limitation: 80%
PAQ-symptoms,
symptom
stability,
treatment
satisfaction,
SFA=12%/54%/32%
QoL, summary
score: 87%
(2015) [32]
Stent Garcia et al.
2009–2011 46 centres in
Self-expandable,
wire-interwoven
nitinol stent
cohort study
Supera Prospective
386
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8
Quality
score
Baseline health status
was signicantly
impaired on both
generic and
disease-specic
Main ndings related to
HRQOL
In patients
measures. There was a
undergoing
revascularization for
moderately complex
SFA disease, use of
the self-expanding
large early gain in
reported health status
scores on all scales at
1month, and these
benets over baseline
were sustained out to
stent was
®
S.M.A.R.T
associated with a high
rate of target
36months follow-up
with minimal
decrement.
Overall, the relative
improvements were
larger in magnitude from
baseline using the
disease-specic PAQ
through 3years and
led to substantial and
sustained health
status benets.
and WIQ instruments
than for the generic
SF-12 and EQ-5D health
J. K. Tun et al.
status instruments.
HRQOL
instrument(s)
used, Method
ofdelivery,
Preop
SF-12, EQ-5D
Completion
rate Key outcomes
Follow-up
period
Yes 36months PAQ, WIQ,
HRQOL
assessment
DM 47%, HTN 89%
250 Mean age 67.7, Male 62%,
Cohort size, Study
centre(s) Patient characteristics
To evaluate the
clinical and health
Study intent/
associated study
status outcomes of
patients undergoing
supercial femoral
artery (SFA)
revascularization for
de novo or
restenotic
femoropopliteal
arterial lesions
using the Shape
Memory Alloy
®
Recoverable
Technology
Not stated vessel patency
Rutherford
)
(S.M.A.R.T.
nitinol self-
100%
2/3/4=46%/51%/3%
USA
expanding stent
through 3years of
follow-up [STROLL
study]
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2018) [33]
Study period,
Study type
Stent Bunte et al.
Device type, Brand
name (if applicable)
2008–2010 39 centres in
study
Self-expandable
bare nitinol stent
SMART Prospective
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
7
(continued)
Women versus men had
inferior walking
distance scores at
presentation (13.6 vs.
25.7, p<0.001), scores
were equalized by
2years (51.6 vs. 60.8,
p<0.05); however,
3-year follow-up
demonstrated less
durable results for
women versus men
(37.3 vs. 58.8, p<0.05).
In addition, women had
worse WIQ scores for
pain, walking speed, and
stair climbing. However,
the relative change in
scores between men and
women were
comparable, with both
groups seeing similar
improvements from
baseline for these
parameters.
assisted primary and
secondary patency
rates in women and
men.
see clinical
improvement after
intervention,
achieving comparable
ABIs and walking
distance to men at
2years. These
benets are
diminished at 3-year
follow-up with
women achieving
lower absolute ABI
and WIQ parameters
compared with men
but improved overall
compared with scores
at presentation.
387
Yes 36months WIQ Comparable primary,
18years old with stenotic,
restenotic, or occluded
lesions of the supercial
femoral artery (SFA) and
proximal popliteal arteries
with moderate to severe
claudication were included.
287 Patients that were at least
This study
investigated the
effects of gender on
the 3-year outcomes
of the StuDy for
EvalUating
EndovasculaR
TreAtments of
Not stated Women continue to
Female (n=97):
71.3±11.2years;
Rutherford
2/3/4=30%/65%/5% Male
(n=190): 65.9±9.9years;
USA
Lesions in the
77%
Rutherford
2/3/4=44%/51%/5%
Women less likely to have
hyperlipidemia (79.4% vs.
89.5%), but otherwise, all
demographics and
Supercial Femoral
Artery and Proximal
Popliteal By usIng
the Protege
EverfLex NitInol
STent System II
preoperative characteristics
were comparable between
the two groups.
More women (64.9%)
presented with severe
claudication (Rutherford 3)
versus men (51.1%,
(DURABILITY II)
trial.
p=0.03). Men had lesions
with more severe degree of
calcication than women.
(2016) [34]
Stent Han et al.
2007–2010 44 centres in
Self-expandable,
bare nitinol stent
study
EverFlex Prospective
388
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9
Quality
score
A statistically
signicant improvement
was seen in all clinical
indicators (resting and
post-exercise ABPI,
Main ndings related to
HRQOL
On intergroup
analysis, PTA and
MWD and PRWD) at all
SEP alone were
equally effective in
improving clinical
outcomes, although
time points, including
the nal endpoint at
1year in all three
treatment arms except
post-exercise ABPI in
the SEP group.
the effect was
short-lived. PTA plus
SEP produced a more
sustained clinical
improvement, but
there was no
signicant QoL
signicant
improvements in all
SF-36 domains and the
VascuQol score, except
in the vitality (V)
advantage.
domain of SF-36.
SEP only: statistically
signicant
improvements in
VascuQol score and in
the PF, role limitation
For patients with
intermittent
claudication due to
femoropopliteal
disease, PTA, SEP,
emotional (RE) and
mental health (MH)
domains.
PTA+SEP: statistically
signicant
improvements in the
and PTA plus SEP
were all equally
effective in improving
walking distance and
QoL after 12months.
VascuQol scores and
SF-36 domains for PF,
BP and SF.
There were no
statistically signicant
differences between the
J. K. Tun et al.
three treatment arms in
any other clinical
indicator, ISCVS
outcomes or QoL
indicators at 12months.
HRQOL
instrument(s)
used, Method
ofdelivery,
Preop
VascuQoL
Completion
rate Key outcomes
Follow-up
period
Yes 12months SF-36,
HRQOL
assessment
groups: PTA only (n=60),
178 Randomised into three
Cohort size, Study
centre(s) Patient characteristics
To compare
percutaneous
Study intent/
associated study
SEP only (n=60),
PTA+SEP (n=58). All
given medical treatment.
Male 60%, Median age 70 Not stated
Vascular Surgical
Unit, University
transluminal
angioplasty (PTA),
a supervised
exercise programme
(SEP) and
combined treatment
81% PTA only: statistically
There were no signicant
of Hull, Hull, UK
(PTA plus SEP) for
intermittent
claudication due to
femoropopliteal
arterial disease.
differences in
demographics, risk factors
or clinical and QoL
indicators at baseline
among the three treatment
groups.
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2012) [35]
Study period,
Study type
PTA vs. SEP vs.
PTA SEP
Device type, Brand
name (if applicable)
2002–2007 Academic
Randomised
control trial
Mazari et al.
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
9
(continued)
FP: No signicant
intergroup differences in
mean physical and
mental scores of SF-36.
intergroup differences in
mean physical scores of
SF-36 in favour of PTA
group.
signicant
improvements in both
AWD and ICD in the
PTA groups for both
trials. The adjusted
AWD was 38%
greater in the PTA
group for the
femoropopliteal trial
(95%; CI 1–90)
(p=0.04) and 78%
greater in the PTA
group for the
aortoiliac trial (95%;
CI 0–216) (p=0.05).
Not stated AI: Signicant
Femoropopliteal:
86%
Aortoiliac: 76%
389
No 24months SF-36 There were
FP (PTA, Control: 48,
45)—differences in mean
age, IHD and statin use
AI (PTA, Control: 19,
Femoropopliteal
(FP): 93
Patients with
symptoms of stable
mild to moderate
intermittent
claudication
(MIMIC) were
al. (2008) [22]
2003–2006 Aortoiliac (AI):
15)—no apparent
differences
34
Nine centres in
UK
randomised in two
multi-centre trials,
for femoropopliteal
and aortoiliac
arterial disease, to
Randomised
control trial
receive either PTA
or no PTA against a
background of
supervised exercise,
smoking cessation
and best medical
therapy and
followed up for
24months.
PTA vs. BMT Greenhalgh et
390
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Quality
score
J. K. Tun et al.
HRQOL
instrument(s)
used, Method
12months 6
Main ndings related to
HRQOL
maintained in 71
(72.4%), and major
EQ-5D Primary patency was
ofdelivery,
Completion
rate Key outcomes
24months
Follow-up
period
Yes 12,
Preop
HRQOL
assessment
Rutherford class 2–4
disease due to
Rutherford: A
signicant shift of
adverse events had
occurred in 17
(17.5%). Secondary
patency rate was
achieved in 89 cases
(84.7%).
with favourable
Not stated PEBs are associated
femoropopliteal lesions
15mm long and with 3- to
7-mm reference vessel
diameter.
Mean age 68 (SD 9), Male
81%, HTN 86%, DM 49%
patients to Rutherford
classes (RC) 0 and 1 is
observed at 3, 6, and
12months post-PEB
procedure (p<0.001).
of patients reporting any
functional and
clinical outcomes at
2years in patients
with femoropopliteal
artery disease
requiring
percutaneous
12months: 88% EQ-5D: The percentage
Rutherford
1/2/3/4=1%/27%/65%/7%
problem across the ve
dimensions of
health-related quality of
life (QOL) was reduced
post-PEB procedure
(p<0.001 for baseline
revascularization.
vs. 3months, 6months,
and 12months).
Rutherford: Statistically
signicant improvement
in Rutherford Class
(RC) from baseline to
SFA/Popliteal=89%/11% 24months: 93% 24 months
post procedure
maintained.
EQ-5D: Signicant
improvement for
mobility, usual
activities, pain/
discomfort (p<0.001)
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
105 Consecutive patients with
Cohort size, Study
centre(s) Patient characteristics
To appraise 2-year
outcomes after
percutaneous
Study intent/
associated study
Study period,
Study type
Device type, Brand
name (if applicable)
treatment of
(2013) [36]
DCB Micari et al.
femoropopliteal
artery disease with
paclitaxel-eluting
Italy
balloons (PEB).
Not stated Six centres in
Paclitaxel-eluting
balloon
study
In.Pact Admiral Prospective
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