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7 Endovascular Treatment ofPeripheral ArteryDisease
152
studies were underpowered and too limited in duration of follow‐up to assess
for this catastrophic outcome.
Atherectomy
The theoretical benefits of atherectomy are based on plaque removal or
modification to facilitate successful revascularization. Currently, four main
atherectomy systems are available: excisional atherectomy, orbital atherec-
tomy, rotational atherectomy, and laser atherectomy (Table 7.8). Atherectomy
is used in a variety of clinical situations based on operator preference. These
include, but are not limited to, debulking or modifying heavily calcified lesions
to allow for complete stent expansion, and primary treatment of obstructive
disease at joints (CFA and popliteal artery) where stents might be more prone
to fracture and adverse clinical sequelae.
Randomized data for peripheral atherectomy are sparse. Excisional atherec-
tomy was studied in a small, randomized trial comparing 29 patients treated
by filter‐protected atherectomy with 29 patients treated with balloon angio-
plasty alone. Target lesion revascularization at 12 months was 16.7% versus
11.1%, respectively (P = NS). Secondary stenting was performed in 62% of the
patients in the balloon angioplasty group versus 28% in the atherectomy group
(P = 0.017). Thus, atherectomy offered no obvious improvement in clinical
results compared with balloon angioplasty, apart from the reduced need for
stents in this small, underpowered trial [57].
Observational evidence for orbital atherectomy in the femoropopliteal seg-
ments have suggested a reduced need for stents as well [58], and a randomized
trial has shown similar results. In COMPLIANCE 360, 50 patients with symp-
tomatic, calcific femoropopliteal disease were randomized to either orbital
atherectomy with angioplasty or angioplasty alone [59]. Procedural success
defined as < 30% residual stenosis was 87% in the atherectomy arm and 19% in
the angioplasty arm (P < 0.001) [59]. Fewer stents were required in the atherec-
tomy group (5.3%) than in the angioplasty‐alone group (78%) [59]. There was
not a statistically significant difference in restenosis at 12 months [59]. It is
difficult to draw firm conclusions from this small trial; however, orbital atherec-
tomy may have a role in achieving procedural success in calcified lesions.
Table 7.8 Available atherectomy devices forperipheral arterial interventions.
Device Company Mechanism
Silverhawk Ev3 Excisional atherectomy
Diamondback Cardiovascular Systems Inc. Orbital atherectomy
Excimer Laser Spectranetics Laser ablation
Jetstream Pathway Medrad Rotational atherectomy with aspiration
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Clinical Evidence forPeripheral Intervention 153
Laser atherectomy was introduced over two decades ago for peripheral
interventions. In a randomized comparison of excimer laser angioplasty versus
angioplasty for the treatment of long SFA occlusions, excimer laser angioplasty
was associated with decreased use of bailout stenting (42% vs. 59%) without
improvement in 12‐month patency [58]. Finally, rotational atherectomy with
aspiration has been shown to be safe, although head‐to‐head comparisons with
other devices are lacking. In a report of 172 prospectively enrolled patients
with infrainguinal disease (31% total occlusions, mean lesion length = 2.7 cm),
the procedural success was 99%, the 30‐day major adverse event rate was 1%,
and the 12‐month restenosis rate was 38% [60].
Specialty Balloons
Cryoplasty, scoring, and cutting balloons are available for peripheral artery
interventions. In a Cochrane review of seven trials comparing cryoplasty with
conventional angioplasty in 478 patients with peripheral artery disease, cryo-
plasty was found to be safe but without a clear benefit in patency over a range
of follow‐up periods (3 months to 3 years) [61]. Data from scoring balloon
angioplasty of femoropopliteal disease are limited at this time. The size matrix
for cutting balloon angioplasty only supports treatment of very short lesions.
Tibioperoneal andPedal Interventions
Tibioperoneal and pedal interventions are usually reserved for patients with
Rutherford category 4, 5, and 6 CLI. Arterial access usually includes antegrade
common femoral access but can also involve retrograde tibial access for reca-
nalization of tibioperoneal occlusions. The use of collaterals and the plantar
loop can also provide retrograde access for revascularization (Figure 7.7). More
recently, skilled and experienced operators are even accessing transmetatarsal
arteries [62]. Higher‐intensity anticoagulation as compared with iliofemoral
revascularization is anecdotally recommended to prevent thrombosis of the
smaller below‐knee vessels [63, 64].
Randomized trial data for tibioperoneal arteries is limited and is non‐ existent
for endovascular pedal revascularization. There are no randomized trials com-
paring surgical with endovascular therapy at this anatomic level. Likewise,
there are sparse randomized data comparing atherectomy with angioplasty
alone, and no randomized trials comparing the various atherectomy devices
with one another or with stenting. Randomized trials do exist for stenting
versus angioplasty alone and for drug‐eluting coronary stenting versus BMS
and angioplasty alone. Given the lack of randomized data, decisions for below‐
knee revascularization rest largely on observational evidence, patient‐specific
factors, and operator experience.
In a meta‐analysis of three randomized trials comparing drug‐eluting stent-
ing with either BMS or angioplasty alone, results were favorable for drug‐ eluting
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7 Endovascular Treatment ofPeripheral ArteryDisease
154
stenting [65]. This analysis included the trials YUKON‐BTK (sirolimus‐eluting
stent vs. BMS), ACHILLES (sirolimus‐eluting stent vs. angioplasty alone), and
DESTINY (everolimus‐eluting stent vs. BMS) [66–68]. In the pooled analysis of
the 501 patients included in these trials, primary patency (80.0% vs 58.5%) and
wound healing (76.8% vs. 59.7%) favored drug‐eluting technology. Of note,
mean lesion lengths were short (~15–30 mm among trials) and should be gen-
eralized with caution when treating longer occlusions commonly encountered
below the knee.
In a meta‐analysis comprising 18 observational studies and 640 patients who
underwent stenting of a tibioperoneal artery for CLI, at 12 months, primary
patency was observed in 78.9% (95% CI: 71.8–86%) and limb salvage in 96.4%
(95% CI: 94.7–98.1%) [69]. Lesions and patient characteristics were not avail-
able in this analysis [69]. Due to the lack of randomization, comparison of stent
types provides limited insight to guide therapeutic decisions [69].
Multiple atherectomy devices are available for treatment of tibioperoneal
arteries, including laser ablation, excisional atherectomy, orbital atherectomy,
and rotational atherectomy (Table 7.8). However, data with these technologies
specific to below‐knee intervention are sparse. Based on the available evidence,
atherectomy of the tibioperoneal or pedal arteries is feasible and safe. For
example, in a study of 52 below‐knee arteries treated with excisional atherec-
tomy, procedural success was 96%. Adjunctive angioplasty was performed in
29% of these lesions, and two required stent placement for flow‐limiting dis-
section. The complication rate was 3% and consisted of target vessel occlusion.
Six‐month patency was 94.1 ± 3.3% [70].
The Laser Angioplasty for Critical Limb Ischemia phase 2 study enrolled 145
patients in whom infrapopliteal disease was treated with laser ablation. The
procedural success was 86%, and the excellent 6‐month limb salvage rate was
93% [71]. CALCIUM 360 was a randomized pilot study comparing orbital
atherectomy followed by angioplasty with angioplasty alone in the treatment of
50 patients with CLI [72]. Of the lesions treated, 90.8% were tibioperoneal.
There was no statistically significant difference in procedural success in the
two arms in this underpowered pilot trial (93.1% for atherectomy/angioplasty
vs. 82.4% for angioplasty alone; P = 0.27). However, a statistically significant
benefit for orbital atherectomy was seen for freedom from target vessel revas-
cularization at 1 year (93.3% vs. 68.4%, P = 0.01). There were no amputations in
either group at 1 year.
Finally, many operators favor guiding revascularization decisions with the
angiosome concept. That is, establishing in‐line flow via arteries directly sup-
plying a wound is thought to potentially improve wound healing as compared
with the more traditional approach of restoring in‐line flow below the knee of
any vessel. In a retrospective observational study of 329 patients followed for a
mean of 18 months, the 200 limbs in which percutaneous revascularization
was achieved in the angiosome of interest had better outcomes than the 169
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Conclusion 155
limbs for which revascularization was performed in a vessel not feeding the
wound’s angiosome [16]. After propensity score matching, freedom from
amputation was 82% ± 5% for limbs that were successfully revascularized
according to the angiosome concept but 68% ± 5% (P = 0.01) for the group with
indirect revascularization [16].
Post-procedural Care
Aggressive cardiovascular risk factor reduction is a key component of post‐
procedural care to prevent cardiovascular events in patients with peripheral
artery disease. Regular exercise should be an integral part of post‐procedural
care because of its well‐established clinical benefit and because it provides a
metric for detecting the progression of obstructive arterial disease. Supervised
exercise therapy is an effective treatment for claudication and may offer addi-
tional benefits after lower extremity revascularization, although supervised
exercise is not reimbursed [23].
In clinical practice, a frequently used pharmacotherapeutic strategy involves
a 4‐week course of dual antiplatelet therapy and subsequent indefinite therapy
with aspirin [23]. However, unlike for coronary stenting, there is no evidence to
guide antiplatelet management following lower extremity intervention. The
duration and intensity of antiplatelet therapy must be balanced against the
individual bleeding risk.
Surveillance strategies for patency depend on the patient’s clinical indication
for revascularization (CLI vs. claudication), the anatomic level that was treated,
available assessment modalities (physical examination, physiologic studies,
duplex ultrasonography, and cross‐sectional imaging), and the expected con-
sequence of restenosis. Guidelines from the ACCF/AHA recommend that
patients with CLI who have been successfully treated be evaluated by a vascu-
lar specialist at least twice a year (class I, level of evidence C) [12]. These guide-
lines also state that patients with a history of CLI should receive instructions
on self‐surveillance (class I, level of evidence C) [12]. A class IIa, level of evi-
dence C recommendation was given that patients with claudication or CLI
who had undergone endovascular therapy could be evaluated in a surveillance
program with physiologic assessment or imaging [12].
Conclusion
Endovascular therapy for PAD is rapidly progressing with technological
advances and increased operator expertise, which allow for revascularization
of increasingly complex anatomy with improvements in patency. Aorto‐iliac
intervention is particularly attractive as an alternative to aorto‐femoral bypass
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7 Endovascular Treatment ofPeripheral ArteryDisease
156
due to lower morbidity and acceptable patency. Suboptimal durability plagues
SFA revascularization, which should improve with emerging technology on
the horizon. Percutaneous tibioperoneal and pedal revascularization is an
important adjunctive therapy for limb salvage in patients with CLI. Due to lack
of randomized trial data and the multitude of available devices for revasculari-
zation, decisions on how to perform endovascular intervention is currently
based primarily on patient‐specific factors and operator experience. Additional
quality evidence in the field of endovascular therapy will better define this
modality’s role alongside medical therapy, supervised exercise, surgery, and
wound care for patients with PAD.
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