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Vascular Disease Management® January 2017 E6

Atherectomy Prior to Drug-Eluting–Balloon Angioplasty in a Calcified Vessel

Marcin K. Kolber, MD1; Robert A. Lookstein, MD2

From 1Mount Sinai Beth Israel and the 2Icahn School of Medicine at Mount Sinai, New York, New York.

Endovascular treatment options for peripheral

arterial disease (PAD) of the lower extremity

include percutaneous transluminal angioplasty

(PTA), stent placement, and atherectomy. However,

PTA alone with or without stenting is associated with

a significant risk of restenosis. Conventional PTA of

femoropopliteal lesions is associated with a restenosis

rate of 40% to 60% at 1 year.1 This is thought to be

a result of vessel trauma, as PTA relies of vessel wall

stretching and eccentric plaque fracture.2 Atherectomy

may debulk atherosclerotic lesions but still results in

late neointimal hyperplasia, possibly related to addi-

tional mechanisms of vessel injury during interven-

tion.3 Drug-eluting technologies, such as drug-eluting

balloons (DEB) and drug-eluting stents (DES) reduce

neointimal hyperplasia via the deposition of antip-

roliferative drug into the medial layer of the treated

artery.2 However, dense atherosclerotic calcification

limits mural drug deposition and probably reduces the

resulting antiproliferative effect.4 Vessel preparation

with atherectomy prior to DEB angioplasty may have

a role in debulking calcific plaque and hence improv-

ing effective drug deposition. Herein, we describe our

preferred method for vessel preparation with rotational

atherectomy prior to DEB angioplasty in heavily calci-

fied vessels.

CASE EXAMPLEA 55-year-old male with coronary artery disease,

peripheral vascular disease, and history of left lower

ABSTRACT: Endovascular treatment options for peripheral arterial disease of the lower extremity include

percutaneous transluminal angioplasty, stent implantation, and atherectomy. Drug-eluting balloons

(DEB) show promise in reducing long-term restenosis and target lesion revascularization rates by

limiting postprocedural neointimal hyperplasia. However, dense calcification is thought to act as a

barrier to successful deposition of antiproliferative drug. Atherectomy prior to DEB angioplasty is one

approach to reduce mural calcification and improve the efficacy of drug delivery.

VASCULAR DISEASE MANAGEMENT 2017;14(1):E6-E10

Key words: drug-eluting balloon angioplasty, atherectomy

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extremity revascularization presented with disabling

right lower-extremity claudication (one-half block).

Antegrade access was obtained in the right common

femoral artery and a long 7 Fr sheath was placed.

Right lower-extremity angiography revealed occlu-

sion of the mid right superficial femoral artery (SFA)

with distal reconstitution via collaterals at the right

popliteal artery and patent 3-vessel runoff to the foot

(Figure 1A and 1B). Parallel linear opacities were

noted along the expected course of the distal SFA

that were compatible with eccentric calcified plaque.

Intra-arterial heparin was administered. A 0.014"

Figure 1. Angiography demonstrates occlusion of the mid-SFA. Note parallel linear opacities were along the expected course of the SFA compatible with eccentric calcified plaque (A). Delayed DSA demonstrates reconstitution of the popliteal artery via collaterals and three-vessel runoff (B). A crossing microwire is advanced through the lesions (C). Rotational atherectomy device is deployed (D). Predilatation is performed to 4mm (E). Overlapping DEB angioplasty is performed (final balloon of 3 is shown) (F). Completion DSA demonstrates a patent SFA and popliteal artery (G).

A B C D

E F G

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wire was used to cross the long segment occlusion,

over which a crossing catheter was advanced, and

the crossing wire was replaced with a stiff support

microwire (Figure 1C). A rotational atherectomy

catheter with active aspiration (Jetstream Atherec-

tomy System, Boston Scientific) was advanced to the

level of the occlusion. One-pass atherectomy was per-

formed in the blades-down position, followed by an

additional pass in the blades-up position (Figure 1D).

Angiography was repeated through the sheath and

revealed improved flow through the previously oc-

cluded segment. A 4 mm balloon was used to predi-

late along the length of the SFA and popliteal artery

(Figure 1E). A 6 mm x 120 mm IN.PACT Admi-

ral DEB (Medtronic) was advanced over the wire to

the popliteal artery, and distal SFA and inflation was

maintained for approximately 3 minutes. The process

was repeated with 2 additional DEBs more proximally

to the level of the mid SFA (Figure 1F). Final digital

subtraction angiography revealed a patent treated ves-

sel and the procedure was terminated.

DISCUSSIONGiven the perceived advantages of drug-eluting tech-

nologies in maintaining long-term vessel patency, our

preference is to utilize DEB and DES when feasible.

Long-segment steno-occlusive disease of the femo-

ropopliteal axis poses challenges to both approaches.

Stents are avoided in long segments and at stress points

unless persistent significant stenosis or flow-limiting

dissection is seen post angioplasty. Our approach with

heavily calcified vessels that would otherwise benefit

from DEB angioplasty is to pretreat the vessel with

a rotational or orbital atherectomy system to debulk

eccentric calcium and improve drug delivery. Fol-

lowing atherectomy, the native lesion is treated as

with standard DEB angioplasty: predilatation is per-

formed 1 mm to 2 mm undersized to the reference

vessel diameter, and the DEB is sized equivalent to

the reference vessel diameter and kept inflated for

1-3 minutes. When the treated lesion length exceeds

the length of the DEB, 1 cm to 2 cm of overlap is

obtained with subsequent balloons.

Paclitaxel selectively inhibits arterial smooth mus-

cle cell proliferation and the ensuing deposition of

extracellular matrix, which otherwise contribute to

neointimal hyperplasia following endovascular inter-

vention.5 DEB delivery of paclitaxel is dependent on

successful penetration and deposition of antiprolifera-

tive drug into the medial layer of the target artery.

Table 1: Randomized Controlled Trials Evaluating Drug-Eluting Balloons

Trial Enrollment Dates Number of Patients Lesion Location Drug-Eluting Balloon Type Comments

THUNDER13 2004-2005 102 Femoropopliteal artery Standard balloon, paclitaxel-coated

Werk et al (Berlin and Greibswald Registry)14

2004-2006 87 Femoropopliteal artery Standard balloon, paclitaxel-coated

LEVANT 19 2009-2009 75 Femoropopliteal artery Lutonix (Bard) Severe calcifications excluded

DEBATE-SFA15 2010-2011 104 Femoropopliteal artery IN.PACT Admiral (Medtronic)

BIOLUX-PI8 2010-2011 60 Femoropopliteal artery Passeo-18 Lux (Biotronik) Severe calcifications excluded

PACIFIER16 2010-2012 85 Femoropopliteal artery IN.PACT Pacific (Medtronic)

IN.PACT SFA17 2010-2013 331 Femoropopliteal artery IN.PACT Admiral (Medtronic)

LEVANT 218 2011-2012 476 Femoropopliteal artery Lutonix

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New technologies aim to minimize loss of drug into

the vasculature and enhance deliverability to the vessel

wall.6 At present, 2 DEBs containing paclitaxel have

received US Food and Drug Administration approval

due to promising long-term restenosis and target le-

sions revascularization rates in clinical trials (Table 1).

Densely calcified atherosclerosis reduces the effi-

cacy of PTA1 and increases the risk for flow-limiting

dissections.7 Furthermore, calcium is not reliably de-

tected by standard angiography. Eccentric calcifica-

tion poses additional problems when DEB angioplasty

is planned. Dense calcification is thought to act as a

physical barrier to penetration, mitigating the per-

ceived long-term benefits of paclitaxel deposition.

This concept was recognized in the planning phases

of several clinical trials. The BIOLUX-PI and LE-

VANT-I trials, which examined the use of DEBs in

femoropopliteal lesions, both excluded heavily cal-

cified lesions.8,9 The BIOLUX-PII trial examining

DEBs in below-the-knee interventions established

noninferiority and safety relative to PTA. However,

in explaining the lack of a statistically significant ben-

efit of DEB angioplasty, the authors suggested that

more baseline calcified lesions in the DCB arm may

have played a role in reduced drug delivery, affecting

outcomes.10

Fanelli et al in 2014 correlated DEB performance

with degree of vessel calcification. In this study, the

authors classified vessel calcification according to cir-

cumferential involvement and length of calcification

as seen on preprocedure computed tomography an-

giography.4 Sixty patients were treated with DEB an-

gioplasty and followed to 12 months. Restenosis was

significantly higher in patients with more complete

circumferential calcium (>270 degrees) relative to

less calcification (<90 degrees), as indicated by ankle-

brachial index, late lumen loss, and primary patency

outcomes. Complications associated with large cal-

cium burden included flow-limiting dissections and

residual stenosis, both occurring only in patients with

>50% circumferential calcifications.4

Cioppa et al in 2012 reported the use of DEB

with directional atherectomy to overcome problems

faced with heavily calcified femoropopliteal lesions.11

Thirty patients underwent directional atherectomy

with TurboHawk (Covidien) followed by DEB with

IN.PACT Admiral paclitaxel-coated balloon. Target

lesions revascularization rate was 10% at 1 year, with

secondary patency of 100%, comparing favorably to

DEB, PTA, or atherectomy alone.12

CONCLUSIONDEB in the femoropopliteal axis is safe, effective,

and demonstrates improved long-term outcomes rela-

tive to PTA alone. Early evidence regarding the use

DEB in densely calcified lesions suggest that efficacy is

decreased with increased circumferential vessel calci-

fication. Debulking with atherectomy is one method

of overcoming this limitation. Early experiences with

this approach have been favorable, but studies exam-

ining its long-term efficacy are lacking. n

Editor’s note: Disclosures: The authors have completed and

returned the ICMJE Form for Disclosure of Potential Con-

flicts of Interest. Dr. Lookstein reports consultancy to Boston

Scientific and research support from Boston Scientific, Bard,

and Veniti Medical.

Manuscript received September 27, 2016; manuscript accepted

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October 31, 2016.

Address for correspondence: Marcin K. Kolber, MD, Mount

Sinai Beth Israel Department of Radiology, 1st Avenue at 16

St., New York, NY 10003 United States. Email: mkolber@

chpnet.org

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