|
Recommendations
for Endovascular Revascularization for
Claudication |
|
COR |
LOE |
Recommendations |
|
I |
A |
Endovascular procedures are
effective as a revascularization option for patients with
lifestyle-limiting claudication and hemodynamically
significant aortoiliac occlusive disease.12,37,38,232,240,242,246
|
|
See Online Data Supplements 35
and 36. |
Two separate systematic analyses
that included RCTs that enrolled patients with aortoiliac
disease reported that endovascular treatment of claudication
improved walking parameters and QoL.11,12,233 The CLEVER trial
enrolled only patients with aortoiliac disease and compared
endovascular therapy to supervised exercise therapy and to
medications alone.37,38 At 6-month follow-up, both the endovascular
therapy and supervised exercise groups had improved peak walking
time compared with medication alone, with a greater improvement
in the supervised exercise group.37 By 18 months, there was
no significant difference between the endovascular therapy and
supervised exercise groups, with a sustained benefit versus
medication alone.38 Other RCTs that included patients with
aortoiliac disease have shown QoL, as assessed by questionnaires
and time to onset of claudication, may be superior with
endovascular treatment in combination with a medical and an
exercise treatment plan, compared versus medical treatment
alone.232,233,246 The ERASE trial randomized patients with
claudication and aortoiliac (as well as femoropopliteal) disease
to endovascular revascularization plus supervised exercise or
supervised exercise alone. After 1 year, patients in both groups
had significant improvements in walking distances and
health-related QoL, with greater improvements in the
combined-therapy group.218 The long-term comparative efficacy of
endovascular revascularization versus supervised exercise
therapy and medical therapy compared to supervised exercise
therapy and medical therapy without revascularization for
aortoiliac disease is unknown. |
|
IIa |
B-R |
Endovascular procedures are
reasonable as a revascularization option for patients with
lifestyle-limiting claudication and hemodynamically
significant femoropopliteal disease.217,232,243–245,250,251
|
|
See Online Data Supplement
35. |
Multiple RCTs have demonstrated
short-term efficacy with endovascular treatment of
femoropopliteal disease for claudication versus supervised
exercise training or medical therapy, with benefit that
diminishes by 1 year.217,232,240–246,250,251 Two separate systematic reviews that
included RCTs that enrolled patients with femoropopliteal
disease, reported that endovascular treatment of claudication
improved walking parameters and QoL.11,12,233 The durability of
endovascular treatment for claudication is directly related to
vessel patency. Long-term patency is greater in the iliac artery
than in the femoropopliteal segment. Furthermore, durability is
diminished with greater lesion length, occlusion rather than
stenosis, the presence of multiple and diffuse lesions,
poor-quality runoff, diabetes mellitus, chronic kidney disease,
renal failure, and smoking.252–255 The choice of endovascular therapy as
a revascularization approach for claudication due to
femoropopliteal disease therefore should include a discussion of
outcomes, addressing the risk of restenosis and repeat
intervention, particularly for lesions with poor likelihood of
long-term durability. |
|
IIb |
C-LD |
The usefulness of
endovascular procedures as a revascularization option for
patients with claudication due to isolated infrapopliteal
artery disease is unknown.256–258
|
|
See Online Data Supplement
35. |
Isolated infrapopliteal disease is
unlikely to cause claudication. Incidence of in-stent restenosis
is high and long-term benefit lacking with bare-metal stenting
of the infrapopliteal arteries.256 Studies that have
enrolled patients with claudication as well as CLI have
demonstrated a benefit of DES versus bare-metal stents or versus
drug-coated balloons for revascularization of infrapopliteal
lesions.257,258 However, these differences were mainly for
patency and restenosis endpoints, and neither of these studies
included patient-oriented outcomes, such as walking function or
QoL parameters. Additional efficacy data on the use of
infrapopliteal drug-coated balloon or DES for the treatment of
claudication are likely to be published in the near future. |
|
III: Harm |
B-NR |
Endovascular procedures
should not be performed in patients with PAD solely to
prevent progression to CLI.234–237,259–261
|
|
See Online Data Supplements 36
and 38. |
There are no data to support a
practice paradigm of performing endovascular procedures on
patients with PAD for the purpose of preventing progression of
claudication symptoms to CLI. Reported rates of amputation or
progression to CLI from prospective cohort studies of patients
with claudication are <10% to 15% over 5
years or more, and increased mortality rate associated with
claudication is usually the result of cardiovascular events
rather than limb-related events.234–237,262 Similarly, there are no
data to support revascularization in patients with asymptomatic
PAD. Procedural risks include bleeding, renal failure from
contrast-induced nephropathy, and the possibility of adverse
limb outcomes.259–261 Therefore, the known risks of
endovascular procedures outweigh any hypothetical benefit of
preventing progression from asymptomatic PAD or claudication to
CLI. |
|