CLINICAL REVIEW Vascular Disease Management ® October 2015 190 The Current State of Endovascular Intervention for Peripheral Arterial Disease Rigved V. Tadwalkar, MD, MS; Michael S. Lee, MD From the UCLA Medical Center, Los Angeles, California. ABSTRACT: The rising incidence of peripheral arterial disease (PAD) has resulted in a concomitant increase in complications such as critical limb ischemia and lower-extremity amputation. Although a full spectrum of therapies exists for femoropopliteal PAD, there is not yet a well-defined consensus on the role of a specific type of endovascular modality that is best suited for treatment. Although percutaneous transluminal angioplasty (PTA) is commonly used for revascularization in PAD due to high initial success rates of around 90%, long-term patency is a concern. Studies comparing drug-eluting balloons to PTA have demonstrated encouraging results with respect to primary patency but inconsistent results from the perspective of freedom from target lesion revascularization and adverse events. While stent placement has primarily been utilized as “bail-out” therapy for PTA with complications, newer generation drug- eluting stents including sirolimus-eluting and everolimus-eluting stents have shown favorable outcomes, suggesting an increasing role for this form of percutaneous revascularization. Although a diverse array of atherectomy devices is available, the role of these devices has yet to be clearly defined due to lack of high-quality studies that are appropriately powered to evaluate for long-term clinical outcomes. Despite this, the continued study of these modalities complemented by refinements in technique for new devices foreshadows a bright future for new endovascular approaches in the treatment of PAD. VASCULAR DISEASE MANAGEMENT 2015;12(10):E190-E203 Key words: peripheral vascular disease, drug-eluting stents, stenting, drug-eluting balloons, atherectomy, critical limb ischemia A s life expectancy continues to increase, comor- bidities that contribute to metabolic syndrome, including diabetes mellitus, have become in- creasingly prevalent. These comorbidities serve as risk factors for the development of peripheral arte- rial disease (PAD), resulting in complications such as lifestyle-limiting claudication and critical limb isch- emia (CLI). More than 200 million people are af- fected by PAD worldwide, with nearly 27 million of those individuals residing in North America and Europe. 1,2 The greater prevalence of PAD has caused a concomitant increase in lower-extremity amputation in the United States, with rise in rate from 19 to 30 amputations per 100,000 person-years over the past 2 decades. 2,3 Treatment for PAD includes pharmacotherapy as well as endovascular and surgical revascularization. Percutaneous vascular intervention (PVI) is an effec- Copyright HMP Communications
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Vascular Disease Management® October 2015 190
The Current State of Endovascular Intervention for Peripheral Arterial DiseaseRigved V. Tadwalkar, MD, MS; Michael S. Lee, MDFrom the UCLA Medical Center, Los Angeles, California.
ABSTRACT: The rising incidence of peripheral arterial disease (PAD) has resulted in a concomitant increase in
complications such as critical limb ischemia and lower-extremity amputation. Although a full spectrum of therapies
exists for femoropopliteal PAD, there is not yet a well-defined consensus on the role of a specific type of endovascular
modality that is best suited for treatment. Although percutaneous transluminal angioplasty (PTA) is commonly used
for revascularization in PAD due to high initial success rates of around 90%, long-term patency is a concern. Studies
comparing drug-eluting balloons to PTA have demonstrated encouraging results with respect to primary patency but
inconsistent results from the perspective of freedom from target lesion revascularization and adverse events. While
stent placement has primarily been utilized as “bail-out” therapy for PTA with complications, newer generation drug-
eluting stents including sirolimus-eluting and everolimus-eluting stents have shown favorable outcomes, suggesting
an increasing role for this form of percutaneous revascularization. Although a diverse array of atherectomy devices is
available, the role of these devices has yet to be clearly defined due to lack of high-quality studies that are appropriately
powered to evaluate for long-term clinical outcomes. Despite this, the continued study of these modalities complemented
by refinements in technique for new devices foreshadows a bright future for new endovascular approaches in the
Rotablator System Boston Scientific RotationalRotating brass burr with diamond crystals
Differential cutting
Jetstream Atherectomy System Boston Scientific
Rotational /aspirational
Rotating front cutting Continuous aspiration
Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc.
OrbitalBidirectional eccentric crown
Plaque modification
CVX-300 Excimer Laser Spectranetics Laser/ablativeBeam of light with photochemical lytic effect
Pulsed energy ablation
Figure 1. Excisional atherectomy utilizes an intra-arterial blade to remove plaque from the arterial wall.
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advantage to this approach as compared to other en-
dovascular interventions includes the ability to maxi-
mize luminal gain by directing treatment toward the
target lesion, even when those lesions are re-stenotic
or excessively calcified.60-62 The initial outcomes from
studies that employed atherectomy were encouraging
but were not considerably different than PTA, thus
limiting use of this technology early on.63 Subsequent
studies of excisional atherectomy have demonstrated
variable primary patency rates at 12 months (43% to
84%) with even poorer rates in re-stenotic lesions.64-66
Moreover, worsening patency and restenosis rates
have been observed in patients with more significant
disease (TASC C+D). A retrospective analysis of pa-
tients with symptomatic lower-limb PAD undergoing
atherectomy with the TurboHawk atherectomy device
(Medtronic/Covidien) by a single clinician on 47 ves-
sels demonstrated 6- and 12-month patency rates of
72.6% and 58.9%, respectively.67 When atherectomy
was assisted by other measures, the primary patency
rate was 93.2% and 74.6% at 6 months and 12 months,
respectively.67 Notably, patients in the earlier cohort
had a patency rate of 41.3% as compared to 82.9% for
patients in the latter cohort (P=.001), indicating that
there may be a learning curve associated with usage
of directional atherectomy.67 Furthermore, the initial
cases included aggressive atherectomy over longer seg-
ments whereas patients near the end of the series were
treated more conservatively over shorter segments.
Rotational atherectomy involves the use of a con-
centrically spinning burr in association with a drive
shaft and turbine.68 The proposed advantage of rota-
tional atherectomy is “differential cutting,” where the
device atherectomizes the diseased inelastic plaque as
opposed to healthy elastic tissue, as well as the abil-
ity to better advance the burr through narrowed and
calcified vessels. Although high initial success rates
have been achieved with the use of rotational ather-
ectomy vs PTA in the coronary circulation (89% vs
80%; P=.0019), TLR is increased (42.4% vs 31.9%;
P=.013).69 Follow-up multicenter data demonstrate
similar lack of benefit in the prevention of restenosis,
limiting use of rotational atherectomy as pretreatment
for heavily calcified lesions prior to stenting.70 Cur-
rently, rotational atherectomy with devices like the
Rotablator (Boston Scientific) is rarely used for PVI.
Improvements to rotational atherectomy technology,
as developed for the Jetstream Atherectomy System
(Boston Scientific), allow for thrombectomy along
with rotational atherectomy from the same catheter
as well as continual active aspiration for the removal
of debris (Figure 2).71 Although a single-center study
utilizing this system revealed 99% device success with
clinically driven TLR rate of 26% at 1 year, a large
Figure 2. The Jetstream Atherectomy System (Boston Scientific) allows for thrombectomy along with rotational atherectomy from the same catheter as well as continual active aspiration for the removal of debris.
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review evaluating this system along with a similar device
showed a combined distal embolization rate of 22% vs
1.9% with excisional atherectomy, vs 0.9% with PTA alone,
and 0.7% with PTA followed by stenting.72,73
Operating with a crown similar to the rotational ather-
ectomy burr, orbital atherectomy (Diamondback 360°
Peripheral Orbital Atherectomy System; Cardiovascular
Systems, Inc.) employs an orbiting action to modify plaque
as well as increase lumen size (Figure 3).74-77 Prospective,
multicenter data evaluating the use of orbital atherectomy
demonstrated that shorter spin times and smaller crown
cluding spasm, embolism, and slow flow, thus underscoring
the importance of technique optimization in utilizing this
device.75 Orbital atherectomy followed by balloon angio-
plasty compared to PTA alone in infrapopliteal disease
demonstrated better procedural success (93.1% vs
82.4%; P=.27) with less bail-out stenting and greater
freedom from target vessel revascularization (TVR)
(93.3% vs 80.0%; P=.14).76 A similar study comparing
orbital atherectomy followed by PTA with PTA alone
in calcified femoropopliteal disease showed freedom
from TLR or restenosis of 77.1% vs 11.5% at 6 months
(P<.001), inferring that plaque debulking with orbital
atherectomy seems to increase the chance of attaining
a desirable angioplasty result.77
Laser technology has also been utilized for the ex-
perimental ablation of atherosclerosis for decades.78
Although previous iterations of laser technology re-
sulted in excessive thermal injury due to continuous
power output, xenon chloride excimer laser delivers
pulsed energy over a shorter period of time, allow-
ing for ablation with less restenosis and thrombosis.79
The LACI trial, a prospective trial involving guide-
wire traversal and excimer laser angioplasty followed
by PTA with optional stenting in patients who were
poor candidates for bypass surgery, reported procedural
success in 86% of treated lesions, with limb salvage
of 92% at 6 months.80 The 8 Fr Turbo-Booster laser
guide catheter (Spectranetics Corporation) allows for
directional ablation along multiple planes resulting
in more targeted ablation (Figure 4).81 The CELLO
Figure 3. Orbital atherectomy (A) employs an orbiting action of a crown to modify plaque as well as increase lumen size (B).
A B
Figure 4. The Turbo-Booster laser guide catheter (Spectranetics Corporation) allows for directional ablation along multiple planes, resulting in more targeted ablation.
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study revealed patency rates of 59% and 54% at 6
months and 12 months, respectively, and total TLR
of 23.1% at 1 year for femoropopliteal lesions.81 A
retrospective review of patients with both lower limb
claudication and CLI evaluating for hard clinical
endpoints underscore the need for an appropriately
selected patient when intervening with laser atherec-
tomy, because negative outcomes are seen in patients
with comorbidities such as renal failure and diabetes
mellitus, even when initial success rates are high.82
Although atherectomy is a promising interventional
modality, a Cochrane Collaboration meta-analysis in-
cluding a total of 220 patients has established that there
is no clear evidence to currently support atherectomy
over PTA for the outcome of primary patency over any
interval of time.83 Additionally, the quality of evidence
on atherectomy is poor, because randomized controlled
trials that have been performed thus far are nonblinded,
improperly powered, and have limited data on adverse
events, making the true outcomes of this modality im-
precise.83
Other technologies, such as cryoplasty, may play an
adjunctive role in PVI. In a prospective, randomized,
multicenter clinical trial of 74 diabetic patients with
90 SFA lesions undergoing BMS placement followed
by postdilation using cryoplasty balloon vs conven-
tional PTA, binary restenosis was significantly lower
in the cryoplasty group (29.3% vs 55.8%; P=.01).84
A meta-analysis of 1,090 patients demonstrated that
brachytherapy, which involves the application of ra-
diation directly to the site of vessel narrowing after
treatment, may be a useful adjunct for the purpose
of maintaining patency and preventing restenosis.85
ECONOMIC CONSIDERATIONSA physician study group on behalf of The Society
for Cardiovascular Angiography and Interventions
(SCAI) systematically reviewed the economics of the
various endovascular modalities in PAD by using a
Markov model to estimate the 24-month budget im-
pact of index procedures and reinterventions in the
United States.86 Index procedures were PTA, DEB,
BMS, and DES while atherectomy was only considered
as a technique for reintervention given the interest in
noncomplex lesions for the analysis. Given the lack
of generalizable evidence, there was no differentiation
among the different atherectomy catheters.
A number of assumptions about the model were
made for the purpose of the analysis. The choice of
therapy in reintervention was based on the opinion
of the authors, only one reintervention was allowed
during the 24-month period, only one device was as-
sumed to be used during an intervention, an assump-
tion was made that stent-based or DCB procedures
would implicate the use of an uncoated balloon for
predilation, and amputations or deaths were not ac-
counted for. Cost assumptions were also made.
The Medicare reimbursement rate for revascular-
ization with DEB was assumed to be similar to PTA
because DEB is not yet approved in the United States,
and the reimbursement rate for revascularization with
a DES was assumed to be similar to BMS because
no separate reimbursement exists as of yet for these
devices. Reimbursement rates were determined by
2013 national fiscal data for PVI. Also, a mix-adjusted
average of Medicare severity diagnosis related groups
(MS-DRGs) was used, with 50% of the procedures
assumed to be performed in the inpatient setting. A
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total of 13 studies with 2,406 patients were included
in this analysis. The average cost per patient over 24
months, including the cost of the index procedure
and the possible cost of reintervention was lowest
for DEB ($10,214) followed by DES ($12,904), PTA
($13,114) and BMS ($13,802). In their analysis, which
also looked at clinical effectiveness, DEB and DES
compared favorably to PTA and BMS from the per-
spective of 24-month TLR, with number-needed-to-
treat in the 4 to 7 range per TLR avoided. On the basis
of these data, drug-eluting strategies and particularly
DEBs offer the lowest budget impact and highest eco-
nomic value when concurrently accounting for clinic
effectiveness. However, due to the assumptions made
for the analysis, the results should be interpreted with
caution.
LIMITATIONS OF CURRENT DATA While developments in the field of endovascular in-
tervention have exciting implications, the heterogene-
ity of the available literature makes drawing definitive
conclusions difficult. Many of the studies have been
limited by design, including varying study size, study
population, study location, type of imaging technique
used, site of intervention, as well as the duration and
intensity of antithrombotic use, all lending to a lack
of gold-standard evidence. Operator and author inter-
pretation of patient cases and preferences for treatment
also produce bias that ultimately affects outcome data.
Further, the use of disparate endpoints including pa-
tency, limb salvage, TLR, TVR, and freedom from
reintervention makes the direct comparison of modali-
ties problematic. Even with many of these limitations
accounted for, it remains to be seen whether enhanced
outcomes beyond 12 to 24 months without excess
adverse events can be accomplished. While higher-
quality studies are required to establish the genuine
efficacy of these evolving modalities, improvements
in device quality and technical expertise will be es-
pecially beneficial.
CONCLUSIONThe current landscape for PVI includes various
technologies that may improve clinical outcomes in
PAD. The use of DEB increases patency and TLR
outcomes in both femoropopliteal and infrapopliteal
PAD. Stenting has a rising role in both bail-out and
primary interventions and is particularly promising
with the development of DES. The proposed advan-
tages of atherectomy have not yet reliably translated
into improved clinical outcomes, although the ef-
fectiveness of this approach will increase with tech-
nique optimization, refinement of the technology,
and further study. Although the guidelines currently
support PVI, particularly PTA with bail-out stenting
conclusively in patients in a low TASC category who
are otherwise not surgical candidates, further study
of these emerging technologies in well-designed and
highly powered trials are needed to determine the
ideal treatment strategies for the management of pa-
tients with PAD. n
Editor’s note: Disclosure: The authors have completed
and returned the ICMJE Form for Disclosure of Potential
Conflicts of Interest. The authors report no disclosures related
to the content herein.
Manuscript received March 4, 2015; provisional acceptance
given June 15, 2015; manuscript accepted July 9, 2015.
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Address for correspondence: Michael S. Lee, MD, 100
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