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19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Quality

score

(continued)

Main ndings related to

HRQOL

WIQ: No statistically

signicant intergroup

differences, except Higher

global WIQ pain score in

endovascular group (p=0.52)

and increased degree of

difculty walking 150m

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

WIQ, EQ-5D-5L ABF group had

higher technical

success

(p=0.001).

Similar limb

salvage and

(p<0.001).

patency rates

between groups.

EQ-5D-5L: No statistically

signicant intergroup

differences in individual or

index scores

length-of-stay

and lower

hospital expenses

in endovascular

group, with a

similar procedure

cost in both

groups.

Not stated Shorter

61% of all; 77%

of those alive

371

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

months

(95% CI =

61.85–

HRQOL

assessment

No 67.84

(endovascular),

62.1±6.5 (ABF)

study

centre(s) Patient characteristics

59 Mean age of 65.6±12.2

Study intent/

associated study

Compare

technical,

clinical, and

economic

period,

Study type

Rocha-

Neves et al.

(2020) [21]

73.83)

outcomes

between

endovascular and

aortobifemoral

bypass grafting

(ABF)/open

approaches in

patients with

Mean Rutherford=3.3,

CLI (n=4)

Centro

Hospitalar

type D aortoiliac

occlusive

disease.

common femoral

2011–2017 Patients with

Similar characteristics in

both groups, except

higher proportion of

CHF and CKD in

endovascular group, and

higher proportion of

smokers in ABF group

de Sao Joao

(referral

center) and

Hospital

Padre

Americo

(regional

hospital),

artery obstructive

disease or

aortoiliac

aneurysmatic

disease were

excluded.

Retros-

pective

cohort

Porto,

Portugal

Type of

intervention

Device type,

Brand name (if

applicable)

Stent versus

surgery

Balloon-

expandable

and

self-

expandable

stents/

double-woven

synthetic graft

372

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Quality

score

Main ndings related to

HRQOL

FP: No signicant intergroup

differences in mean physical

signicant

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

and mental scores of SF-36.

differences in mean physical

scores of SF-36 in favour of

PTA group.

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

Not stated AI: Signicant intergroup

Femoropop-

liteal—86%

Aortoiliac—76%

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).

J. K. Tun et al.

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

No 24months SF-36 There were

FP (PTA, Control: 48,

45)—differences in

mean age, IHD and

study

centre(s) Patient characteristics

Femoro-

popliteal

(FP)—93

Study intent/

associated study

Patients with

symptoms of

stable mild to

period,

Study type

et al. (2008)

[22]

statin use

AI (PTA, Control: 19,

15)—no apparent

differences

(AI)—34

moderate

intermittent

claudication

(MIMIC) were

2003–2006 Aortoiliac

Nine centres

in UK

randomised in

two multi-centre

trials, for

femoropopliteal

Randomised

control trial

and aortoiliac

arterial disease,

to receive either

PTA or no PTA

against a

background of

supervised

exercise, smoking

cessation and

best medical

therapy and

followed up for

24months.

Type of

intervention

Device type,

Brand name (if

applicable)

Table 19.2 (continued)

PTA vs. BMT Greenhalgh

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Quality

score

Main ndings related to

HRQOL

6months

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

SF-12, WIQ, PAQ Both SE and ST

had better

18-month

than the OMC group for every

QOL measure except the

outcomes than

OMC.SE and

ST provided

comparable

durable

Not stated The ST group improved more

SF-12 mental summary scale

and the WIQ stair-climbing

scale. The SE group improved

more than the OMC group for

improvement in

functional status

and in quality of

life up to

18months. The

every scale except SF-12

mental, WIQ pain, WIQ stair

climbing, PAQ symptom

durability of

claudication

exercise

stability, and PAQ treatment

interventions

satisfaction. Compared with

SE, ST was associated with

merits its

signicantly greater benet

across most of the

disease-specic QOL measures

but not for the generic scales.

The difference between ST and

consideration as

a primary PAD

claudication

treatment.

SE for the PAQ overall

summary score (14.78 points)

exceeded the 8-point difference

that has been considered to be

clinically meaningful. More

patients in the ST group than

the SE group reported no

claudication symptoms on the

WIQ.

6months 18months

differences in quality of life

among the treatment groups.

At 18months, improvement

in disease-specic scales

(WIQ, PAQ) was statistically

superior for ST and SE

compared with OMC, but ST

and SE differed signicantly

from each other (favouring

18months

SF-12 Physical:

69%

WIQ-pain: 71%

WIQ-walking

373

ST) only for PAQ symptoms,

PAQ treatment satisfaction,

PAQ quality of life, and PAQ

summary.

distance: 70%

PAQ-physical

limitation,

symptoms, QoL:

68%

PAQ-summary:

69%

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

6, 18

months

HRQOL

assessment

age with moderate-to-

severe claudication that

study

centre(s) Patient characteristics

111 Adults over 40years of

Study intent/

associated study

To report the

longer-term

(18-month)

period,

Study type

Murphy et

al. (2015)

[14]

was due to aortoiliac

PAD.

Randomised into three

groups: OMC only,

OMC+ST (ST),

OMC+SE (SE).

(USA,

Canada)

efcacy of

supervised

exercise (SE)

compared with

stent

revascularization

2007–2011 29 centres

Mean age 64.4±9.5,

Male 62%

DM 24%, HTN 85% 89% There were no baseline

Baseline characteristics

of the three study groups

were similar.

There were no signicant

differences in baseline

characteristics between

the 79 patients who

completed the 18-month

treadmill test and the 32

patients who did not.

(ST) and optimal

medical care

(OMC) in

claudication due

to aortoiliac

peripheral artery

disease

[CLEVER study]

Randomised

control trial

Type of

intervention

Device type,

Brand name (if

applicable)

Stent versus

Supervised

exercise

374

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J. K. Tun et al.

Studies Focused onFemoropopliteal Steno-Occlusive disease

Twenty-six articles were identied which focused on surgical and/or endovascular interventions for femoropopliteal steno-occlusive disease. Details of outcomes are shown in Table19.3.

A three-arm RCT which evaluated PTA, SET, and a combination of PTA and SET demonstrated some improvement in both generic and disease specic HRQOL measures when compared to baseline, although no signicant difference was seen between the three treatment groups [35]. Another two-arm RCT which compared BMT, smoking cessation therapy and SET to BMT, smoking cessation, SET and PTA demonstrated no signicant difference in SF-36 scores [22].

Four multicentre prospective cohort studies investigated outcomes of femoropopliteal angioplasty with DCBs, all of which demonstrated improved HRQOL measures when compared to baseline [12, 36, 37, 39]. Two of these were conducted by the same research group studying the effectiveness of a DCB (IN.PACT Admiral, Medtronic) on shorter (<15 cm) and longer (>15 cm) femoropopliteal lesions [12, 36]. An additional cohort study investigating the use of DCB in in-stent restenosis demonstrated a trend towards improvement in HRQOL outcomes, although no statistically signicant difference was seen [38].

Five multicentre RCTs compared the use of a specic DCB device to standard PTA (four different DCB devices studied in total). All of the studies demonstrated improved HRQOL measures for both the PTA and DCB treatment groups at 12-month follow-up compared to baseline [7,

40–43]. One of these studies by Roseneld etal.

demonstrated statistically signicant better outcomes with DCB when compared to PTA in one item of the HRQOL measures obtained (‘Walking distance’ item of the WIQ) [40]. No signicant difference in HRQOL outcomes between DCB and PTA were found in the other four studies.

In total, eight studies investigated HRQOL outcomes of femoropopliteal artery stenting. One retrospective cohort study and four prospective cohort studies evaluated HRQOL outcomes fol-

lowing self-expanding nitinol bare metal stenting for femoropopliteal disease [30–34]. All studies demonstrated signicantly improved HRQOL outcomes when compared to baseline. Of these studies, Han etal. specically looked at gender difference in HRQOL outcomes post stenting. Although HRQOL measures improved for both men and women, there was less sustainability of HRQOL outcomes for women at 3years.

Two of the eight studies were multicentre RCTs which compared different stents. One of the studies compared a covered self-expanding nitinol stent to a bare metal self-expanding nitinol stent [28]. Both stents demonstrated poor primary patency rates, however, a sustained improvement in HRQOL scores was demonstrated at 3years for both groups. The authors did not present a statistical comparison of the HRQOL outcomes between the treatment groups, though the outcomes appear to be similar. The other study compared two different selfexpanding bare metal nitinol stents placed in the femoropopliteal segment. No difference was identied in HRQOL outcomes between the two stents at 24 months, but an improvement was seen for each stent compared to the baseline [29].

The nal study was a multicentre RCT which compared primary stenting of supercial femoral artery (SFA) lesions to BMT.This demonstrated signicant improvement in HRQOL outcomes in the stenting group, but no improvement in the BMT group [9].

Two of the studies identied were RCTs that compared stenting to PTA in the femoropopliteal segment. The rst study by Laird etal. demonstrated a signicant improvement in HRQOL outcomes at 12 months in both groups [44]. Primary patency was signicantly higher in the stent group, but no signicant difference in HRQOL measures was seen between the groups. A subgroup analysis of the WIQ scores did, however, nd signicantly better outcomes with respect to claudication pain in the stent group. The other RCT study by Chalmers et al. also demonstrated improved HRQOL measures post intervention, but no difference between the groups. A signicantly worse HRQOL outcome

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Quality

score

(continued)

Main ndings related to

HRQOL

Rutherford: Overall

3.3±1.2 at baseline to

1.2±1.4 at 1year

(p<0.001); mean

change IC (−1.6±1.1)

HRQOL

instrument(s)

used, Method

ofdelivery,

Completion

rate Key outcomes

Follow-up

period

and CLI (−3.1±1.8)

patency rate was

75.0% (IC patients

78.2% and CLI

patients 67.5%,

p=0.118). The

EQ-5D (VAS):

increased from a mean

of 64.1±20.1 at

freedom from major

amputation in both

cohorts was 100%.

(≤30% residual

stenosis) was

baseline to 72.3±17.7

at 1year (p<0.001)

improved in IC cohort

only with a mean score

of 21.0±23.3 at

baseline increasing to

achieved in 84.4% of

treated lesions;

adjunctive stenting

was required in 6

(3.7%) of the 162

lesions.

77% WIQ: walking distance

48.7±39.2 at 1year

(p<0.001).

375

Preop

HRQOL

assessment

Mean age 72.0±10.9years Ye s 12months EQ-5D, WIQ The 1-year primary

Cohort size, Study

centre(s) Patient characteristics

158 (162

Study intent/

associated study

To report the

Author (year of

publication),

Study period,

Study type

procedures)

effectiveness of

directional

atherectomy for the

treatment of

(2018) [23]

82 men (52%) Not stated Procedure success

popliteal artery

occlusive disease

[DEFINITIVE LE

Trial]

2009–2012 Multicentre

48 (30%) CLI, 110 (70%)

(n=47) (Europe,

USA)

Similar characteristics in

the IC and CLI cohorts

with the exception of

diabetes, which was more

common in the CLI

study

patients.

Of the patients with IC, the

majority had RC 3

ischemia (71, 64.5%),

whereas three-quarters of

the CLI patients (36, 75%)

had ischemic wounds (RC

categories 5/6).

Type of intervention

Table 19.3 Studies including interventions on femoral-popliteal steno-occlusive disease

Device type, Brand

name (if applicable)

Atherectomy Rastan et al.

Directional

atherectomy

catheter

SilverHawk Prospective

376

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Quality

score

Rutherford classication

improved in 120/144

(83.3%) from baseline

Main ndings related to

HRQOL

(p<0.001).

97% (192/198)

achieved primary

efcacy outcome of

technical success

(<50% residual

diameter stenosis).

VascuQol score and

SF-12 Physical

component score

signicantly improved

from baseline

(p<0.001).

adverse events

outcome through

6months occurred in

25 (16.6%) of 151

subjects.

atherectomy for

femoropopliteal

disease is safe and

effective.

Additionally, the

precision afforded by

OCT guidance leads

to greater removal of

plaque during

atherectomy while

sparing the adventitia.

J. K. Tun et al.

HRQOL

instrument(s)

used, Method

ofdelivery,

Preop

VascuQoL

Completion

rate Key outcomes

Follow-up

period

Yes 6months SF-12,

HRQOL

assessment

67.2±10.5years; 55%

Cohort size, Study

centre(s) Patient characteristics

158 (198 lesions) Mean age

Study intent/

associated study

To evaluate the

safety and efcacy

men

of a novel optical

coherence

tomography

DM 44%, HTN 91% Not stated The composite Major

USA, 1 Europe)

(OCT)–guided

atherectomy

catheter in treating

patients with

symptomatic

femoropopliteal

86% OCT-guided

SFA 81%, SFA/Pop 6%,

Popliteal 13%

disease [VISION

Study]

Author (year of

publication),

Study period,

Study type

Type of intervention

Table 19.3 (continued)

(2017) [24]

Device type, Brand

name (if applicable)

Atherectomy Schwindt et al.

2014–2015 20 centres (19

Optical coherence

tomography-

guided

atherectomy

catheter

cohort study

Pantheris Prospective

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

(continued)

Primary bypass

occlusion did not affect

QOL scores.

Bypass patency at the

end of follow-up (open

[with or without

intervention] versus

occluded) did not result

in signicant difference

in QOL scores.

Amputees vs.

Non-amputees (WIQ,

EQ-5D, EQ-VAS): 0.16,

0.487, 66/0.42, 0.496,

Dacron (0.49) higher

WIQ score than PTFE

(0.26). No signicant

difference in EQ-5D and

EQ-VAS.

signicantly associated

with better WIQ,

EQ-5D, and EQ-VAS

scores.

A better WIQ score is

signicantly associated

with a better QoL (p

0.001)

Primary outcomes

were QOL scores.

Secondary: 5-year,

10-year survival was

EQ-5D,

EQ-VAS, WIQ

84months

58%, 51%.

administered

(3–135) Self-

Bypass failure

occurred more

frequently in pts

treated with a bypass

survivors)

occlusion.

score signicantly

associated with

occlusion, but no

signicant association

with graft type.

377

No Mean

presenting with

claudication, ischaemic rest

pain, gangrene.

PTFE (n=77), Dacron

(n=63)

140 Consecutive patients

Study of long-term

QoL and mobility

(2012) [25]

Zoetermeer,

Netherlands

after supragenicular

prosthetic

femoropopliteal

bypass (PTFE vs.

Dacron)

1997–2003 Amsterdam and

Mean age 66 (37–87) 89% (63/71

Prospective

observational

study

66% Male Rutherford runoff

HTN 68% Male sex was

62% no previous

intervention

Rutherford 1, 2, 3 (58%,

21%, 21%)

n=69 died during

follow-up

Bypass grafts Bosma et al.

Prosthetic Dacron

and PTFE grafts

378

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Quality

score

Both EQ-5D scoring

systems showed

generally lower values

with increasing disease

severity as described by

Main ndings related to

HRQOL

No signicant

intergroup differences

the Rutherford

of restenosis. Fewer

TLR in stent group

but not statisitically

different. No

classication.

Both sets of scores were

similar for both groups

of patients at each time

point. Both treatment

difference in rate of

amputation.

long lesions in

predominantly

occluded supercial

strategies resulted in a

marked and statistically

signicant increase in

utility score from

baseline to 3months

(p<0.0001 for both),

which was maintained

femoral arteries does

not reduce the rate of

binary restenosis

compared with

balloon angioplasty

and bailout stenting.

to 12months, also for

both groups.

Some patients with

restenosis had very low

scores at 12months

compared with those

who did not, as reected

by a much lower 25th

percentile (0.15 vs. 0.62

respectively).

J. K. Tun et al.

HRQOL

instrument(s)

used, Method

ofdelivery,

Preop

EQ-VAS

Completion

rate Key outcomes

Follow-up

period

Yes 12months EQ-5D Utility,

HRQOL

assessment

occlusion or severe stenosis

Cohort size, Study

centre(s) Patient characteristics

150 Patients with SFA

Study intent/

associated study

To determine

whether primary

Not stated Primary stenting of

randomized to either

primary stenting with the

SMART stent or PTA (with

bailout stenting).

stenting reduces the

rate of restenosis

compared with

balloon angioplasty

alone in the

endovascular

treatment of long

age 65.9±9.0; Male 78%;

DM 31%; HTN 66%

supercial femoral

artery lesions; and

to assess the effect

of treatment on

quality of life.

EQ-5D Utility:

75%

EQ-VAS: 77%

PTA group (n=76): Mean

age 69.8±8.5; Male 86%;

DM 38%; HTN 67%

There were minor

imbalances between the

two groups, none of which

reached statistical

signicance, apart from

age, where patients

randomized to PTA were

3.9years older (p<0.01).

High proportion of vessels

being totally occluded

(95.9% and 90.8% in the

stent and PTA groups,

respectively). Stent group

had signicantly longer

occlusions than those

randomized to PTA

(83.9±46.3mm vs.

62.8±37.1mm, p<0.01);

all other baseline lesions

characteristics were similar.

Author (year of

publication),

Study period,

Study type

Type of intervention

Table 19.3 (continued)

(2013) [26]

Device type, Brand

name (if applicable)

Stent versus PTA Chalmers et al.

2005–2008 17 centres in UK Stent group (n=74): Mean

Self-expandable,

nitinol stent

control trial

Cordis SMART Randomised

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

(continued)

Both treatment groups

demonstrated a

signicant improvement

in all QOL measures at

6 and 12months

compared with baseline.

The baseline SF-8

physical score was

41.0±10.5 (PTA) and

41.4±9.2 (stent). SF-8

increased similarly in

both groups (5.9±11.2

versus 5.7±11.2;

p<0.0001 versus

baseline). Walking

distance score was

22.3±23.2 (PTA) and

22.8±24.2 (stent).

Walking distance scores

had increased similarly

in both groups

(29.4±37.4 versus

25.6±34.6; p<0.0001

versus baseline).

Patients in the PTA

group reported more

claudication pain at

12months than patients

in the stent group

(Walking Impairment

Questionnaire

evaluation, p<0.009),

but there were no other

signicant differences in

QOL measures between

treatment groups (t test

p>0.05).

(30% residual

stenosis) was superior

for the stent group

compared with the

angioplasty group

(95.8% versus 83.9%;

p<0.01).

lesion

revascularization was

87.3% for the stent

group compared with

45.1% for the

angioplasty group

(p<0.0001).

derived primary

patency at 12months

was better for the

stent group (81.3%

versus 36.7%;

p<0.0001).

379

Yes 12months SF-8, WIQ Acute lesion success

treatment with either a

self-expanding nitinol stent

after predilation (n=134)

or PTA (n=72).

206 2:1 randomization ratio to

Outcomes of Nitinol

Stent Implantation

Versus Balloon

Angioplasty for

Obstructive Lesions

in the Supercial

Femoral Artery and

Proximal Popliteal

Artery with IC at

Not stated Freedom from target

Baseline patient

demographics (age, sex,

and race) and pre-

procedure classication of

symptoms (Rutherford

category and ankle brachial

(Europe, USA)

12months

(RESILIENT

Randomised Trial)

83% Duplex ultrasound-

index) were not

signicantly different

between treatment groups

(p<0.05).

Pre-existing risk factors

were not signicantly

different between patient

groups (p<0.09), except

PTA group had a

signicantly higher

reported prevalence of

hypertension than the stent

group (p<0.03).

Lesion characteristics were

similar between the two

treatment groups.

(2010) [44]

Stent versus PTA Laird et al.

2004–2006 24 centres

Self-expandable,

bare nitinol stent

control trial

LifeStent Randomised

380

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Quality

score

At 1month: SF-36

signicantly better in

endoluminal group (50.2

vs. 37.1; p=0.011).

Overall WIQ scores in

Main ndings related to

HRQOL

IC patients were

endoluminal bypass

for long segment

lesions shows

promising results

(less morbidity, faster

signicantly better in

endoluminal group.

Endoluminal group

showed an earlier

improvement too.

At 12months:

Improvement in most

recovery, and

improvement in

quality of life with

indistinguishable

patency rates at

1year) compared

with surgical bypass.

domains of SF-36 in

both groups from

baseline. No signicant

differences between

groups, except for

experienced Health

change (endoluminal

better).

Signicant improvement

in all WIQ domains in

IC patients in both

groups from baseline,

while stairs domain

better in endoluminal

group.

J. K. Tun et al.

HRQOL

instrument(s)

used, Method

SF-36, WIQ Heparin-bonded

ofdelivery,

Completion

rate Key outcomes

and

Follow-up

period

Yes 1month

Preop

HRQOL

assessment

Surgical n=62

125 Endoluminal n=63,

Cohort size, Study

centre(s) Patient characteristics

To compare

heparin-bonded

Study intent/

associated study

12months

endografts with

femoropopliteal

bypass, including

quality of life, using

general health and

Mean age 69, 67 Self-

disease-specic

questionnaires as

well as patency

rates.

administered

(optional help

from nurses)

Netherlands

(endoluminal),

89% (surgical)

Male 73%, 80% 81%

Rutherford Cat 3 (IC) 62%,

68%

No signicant differences

between groups at baseline

in demographics and

anatomical details.

Similar baseline HRQOL,

except worse SF-36 Mental

health and higher Health

Change in endoluminal

group.

Author (year of

publication),

Type of intervention

Table 19.3 (continued)

(2017) [27]

Study period,

Study type

Stent versus

bypass

Device type, Brand

name (if applicable)

2010–2015 Six centres in

Heparin-bonded

ePTFE

endografts/venous

and prosthetic

bypass grafts

Randomised

control trial

Reijnen et al.

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