Circulation: Cardiovascular Interventions

CONTEMPORARY REVIEWS IN INTERVENTIONAL CARDIOLOGY

Calcium Modification Techniques in Complex

Percutaneous Coronary Intervention
Mohammed Shah, BSc, MBChB; Osman Najam, MBChB, MRes; Ravinay Bhindi, MBBS, PhD; Kalpa De Silva , MBBS, PhD

ABSTRACT: Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken
in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and
significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness
and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for
increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to
mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies,
due to the severity of calcification. There have been several substantial technological advancements in calcium modification
methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This
review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes
in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.

Key Words: algorithm ◼ calcium ◼ coronary artery disease ◼ percutaneous coronary intervention ◼ stents

T
he ability of percutaneous coronary intervention calcification. The mainstay of lesion preparation in PCI is
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(PCI) to treat anatomically complex coronary artery
disease within high-risk patient subsets, has sig-
nificantly improved over the past 2 decades.1 However,
despite improvements in interventional techniques, cor-
onary artery calcification represents a major challenge
associated with adverse outcomes after PCI.2 The preva-
lence of coronary artery calcification increases with age,
occurring in >90% of men and 67% of women over the
age of 70 years.3 As more than a third of all PCI proce-
dures are performed in those over 75 years, an improved
understanding and treatment of calcific coronary dis-
ease is vital.1,4,5 Treatment with PCI remains difficult due
to a number of anatomic and technical factors. Calcified
coronary arteries have reduced vessel compliance pro-
hibiting stent delivery, while also reducing the ability of
implanted stents to expand and appose as required, all
potentially culminating in a nidus for stent failure through
either restenosis or stent thrombosis.6
Evolution of PCI technique over the last 40 years has
meant that adjunctive methods of lesion preparation have
been developed in an attempt to combat coronary artery
with balloon angioplasty (BA), with the use of semi-com-
pliant or non-compliant balloons, which are limited and
are associated with increased procedural complications
in the presence of calcific disease.7–9 Therefore, effec-
tive and efficient calcium modification remains an unmet
need. This review will summarize the current adjunctive
technologies that can be employed to improve techni-
cal outcomes in PCI and the evidence supporting these
tools.
UTILITY OF INTRACORONARY IMAGING
TO GUIDE CALCIUM MODIFICATION
The use of intracoronary imaging to guide PCI improves
procedural and long-term clinical outcomes.10 Both intra-
vascular ultrasound (IVUS) and optical coherence tomog-
raphy (OCT) provide important insights into coronary
lesion morphology and allow improved procedural plan-
ning during PCI. IVUS (Figure 1) and, particularly OCT
(Figure 2), are also invaluable in detecting, localizing,

Correspondence to: Kalpa De Silva, MBBS, PhD, Cardiology Department, St. Thomas’ Hospital, London, SE1 7EH, United Kingdom. Email kalpa.desilva@nhs.net
The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCINTERVENTIONS.120.009870.
For Sources of Funding and Disclosures, see page 566.
© 2021 American Heart Association, Inc.
Circulation: Cardiovascular Interventions is available at www.ahajournals.org/journal/circinterventions

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 Shah et al Calcium Modification in PCI

presence of large calcium pools (≥180°) and absence

Nonstandard Abbreviations and Acronyms of calcium fractures following initial lesion preparation,
escalation of preparation technique should be considered
ALG acute luminal gain (Figure 4).14 Conversely, the presence of OCT-detected
BA balloon angioplasty fractures following lesion preparation is a reassuring fea-
CB cutting balloon ture and associated with improved stent expansion.15,16
IVL intravascular lithotripsy While there is limited evidence that the presence of cal-
IVUS intravascular ultrasound cific disease adversely impacts subsequent clinical out-
NCB noncompliant balloon comes, more meticulous procedural planning, with the
systematic use of intracoronary imaging, may improve
OCT optical coherence tomography
technical success and procedural safety.
PCI percutaneous coronary intervention
RA rotational atherectomy
SB scoring balloons CALCIUM MODIFICATION TECHNIQUES
Balloon-Based Devices
Non-Compliant Balloons
and quantifying coronary calcification (Figure 3).10a OCT Conventional BA is often effective in modifying coronary
is able to visualize calcified plaque without artifacts and, lesions, with either the use of semi-compliant or non-
therefore, can evaluate the calcium thickness more compliant (NCB) balloons. Frequently, predilating lesions
accurately than IVUS (Figure 2).11–13 The presence of with NCB’s sufficiently prepares lesions and allows stent
extensive lesion calcification may adversely impact the implantation to achieve an appropriate minimal stent area.
PCI outcome and is associated with a greater likelihood However, in the setting of concentrically calcified lesions,
of stent under-expansion. The 2019 European Society despite the use of NCB’s to high pressures, there may
of Cardiology intracoronary imaging consensus guide- be non-uniform balloon expansion, with relative under-
lines recommend the use of OCT or IVUS where there expansion in the calcified segment of the lesion compared
is ambiguity in regard to the presence, and burden, of with the edges of the lesion, commonly referred to as a
lesion calcification. Specific imaging features, particularly dog-bone appearance. This feature suggests that there is
with the use of OCT’s higher spatial resolution, have been inadequate lesion preparation and also may result in bal-
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identified as indicators of stent under-expansion. These loon rupture, vessel dissection, or perforation.14 Although
are the presence of an arc of calcium ≥180°, calcium standard NCB’s can be expanded to high pressures
thickness of ≥0.5 mm and lesion length >5 mm. In the (rated pressure of 20–24 atm), the single layer structure

Figure 1. Intravascular ultrasound (IVUS) image of arterial calcification.

A, HD-IVUS (60 MHz) image showing mild eccentric calcification identified by hyperechoic region of calcium in upper right quadrant (red arrow),
with hypoechoic ultrasound drop out (blue arrow) in the region adjacent to this, due to the inability of ultrasound waves to penetrate through
calcium. B, HD-IVUS image showing concentric calcification, with 360° arc of hyperechoic calcification and complete ultrasound drop-out.

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 Shah et al
Figure 2. Optical coherence tomography (OCT) image of arterial calcification.
A, OCT image showing eccentric, superficial calcium (lower left quadrant). Arc of calcium is <90° with a calcium thickness of 0.24 mm. B,
OCT image showing concentric calcification with deep wall calcification—0.84 mm at its thickest point (at 9 o’clock).
of the balloon makes them prone damage in the presence
of calcium, particularly if this is spiculated in nature.
High-Pressure (Dual-Layer) Non-Compliant Balloons
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The advent of super high-pressure (35 atm rated pres-
sure) dual layer balloons such as the OPN balloon (SIS
Medical, Switzerland) have provided a low-profile device
which can exert very high pressures on the lesion with
increased uniformity (Figure 5A).17–20 Díaz et al17 were
the first to test the super high-pressure balloon at 40 atm
in a small case series (n=8). These were cases of unex-
pandable stents, in-stent restenosis, or plaque preparation
before stent implantation, with no dissections, perfora-
tions, or balloon rupture observed. Secco et al21 recently
conducted a retrospective analysis (n=91) showing that
when conventional NCB’s fail, OPN balloons provide an
effective strategy for the dilatation of undilatable calcific
lesions. Acute luminal gain (ALG) was significantly greater
with OPN (41.1±15.8% versus 20.2±14.9%, P<0.001),
with a procedural success rate of 92.4% with no coro-
nary perforations recorded. A number of other case series
have shown the OPN balloon to be an effective and safe
tool for lesion preparation and stent postdilatation.20 While
the data for this device are limited to small case series, all
portray a device that is simple to use and effective, with
no signal of increased risk (Table 1 and Table I in the Data
Supplement). Lesion selection remains challenging as
it remains unclear when this type of device would be of
definitive benefit. Following the use of a standard NCB
balloon, the presence of a undilatable, moderate-severely
calcified, lesion should lead to the escalation to an OPN
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Calcium Modification in PCI
(or another device) depending on the composition of the
lesion (Figure 4). However, the use of such devices must
be reconciled with the potential risk of coronary dissec-
tion and perforation, the latter of which, in particular, can
be catastrophic and require emergent resolution. Finally,
while effective, it should be noted that high-pressure bal-
loon treatment may lead to localized wall injury, which may
provide an endothelial substrate for restenosis22,23
Cutting and Scoring Balloons
Cutting Balloons
The cutting balloon (CB) is a balloon that has 3 or 4
microsurgical blades bonded longitudinally along its sur-
face (Figure 5B). The device provides a focused force,
at low balloon inflation pressures, creating shallow inci-
sions in the calcified atherosclerotic plaque. This exposes
the more elastic intimal tissue, allowing for greater vessel
compliance and potentially improved stent expansion (Fig-
ure 6).24 Karvouni et al25 conducted a retrospective analy-
sis of calcified lesions (n=29 patients with 37 calcified
lesions), comparing CB with standard balloon treatment
of the equivalent size. Fluroscopic analysis demonstrated
that ALG with low-pressure CB dilatation, was significantly
higher than BA (1.51±0.49 versus 0.93±0.48; P<0.0001).
Further small-scale trials have consistently demonstrated
that the technique is potentially superior to traditional
BA and crucially, not associated with higher intraproce-
dural complications. Jujo et al26 provided OCT insights of
improved plaque modification and greater stent expansion
(70% versus 61%, P=0.017) achieved with CB compared
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 Shah et al Calcium Modification in PCI
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Figure 3. Comparison of optical coherence tomography (OCT) vs intravascular ultrasound (IVUS) imaging.
PCI indicates percutaneous coronary intervention. Adapted from Maehara et al10a with permission. Copyright ©2017, American College of
Cardiology Foundation.

with NCB. Furthermore, the CB group had significantly
reduced angiographic restenosis at follow-up (15% ver-
sus 28%, P<0.01). Ozaki et al27 conducted an early ran-
domized trial (n=521) of predilation with CB versus NCB
in bare metal stent PCI. The post-procedure minimal stent
area (P=0.002) and residual diameter stenosis (P=0.039)
were significantly improved in the CB arm. Subgroup anal-
ysis revealed that IVUS-guided sizing of the CB predila-
tation independently predicted improved post-procedure
minimal stent area. More recently, a large retrospective
single center analysis (n=737) compared the use of CB,
BA, and rotational atherectomy (RA) in drug eluting stent
(DES) PCI. This showed a similar rate of major adverse
cardiovascular event (MACE) (P=0.20), target lesion
revascularization (P=0.76), and death (P=0.18) across the
3 modalities. However, it should be noted that direct com-
parison between techniques is fraught with difficulty, as
lesion, and patient, characteristics are likely to be markedly
different between the 3 groups.28 Latterly, the PREPARE-
CALC RCT, randomly assigned those undergoing PCI with
Orsiro Sirolimus DES (Biotronik, Switzerland) to either
CB/scoring balloons (SB) or RA (n=100 in each arm).
The main inclusion criteria were angiographically proven
coronary artery disease; presence of anginal symptoms or
reproducible ischemia in the target area by electrocardi-
ography, functional stress testing, or FFR; target reference
vessel diameter between 2.25 and 4.0 mm; luminal diam-
eter reduction of 50% to 100%; and severe calcification
of the target lesion as defined by angiography (radiopaci-
ties noted without cardiac motion before contrast injection
generally compromising both sides of the arterial lumen).
The main exclusion criteria were MI within one week,
decompensated heart failure, target lesions in coronary
artery bypass grafts, in-stent restenosis, and target ves-
sel thrombus. The primary end points were strategy suc-
cess and 9 months in-stent late-lumen loss. While strategy
success was greater in the RA group (98% versus 81%,
P=0.0001), at 9 months, mean in-stent late-lumen loss
was 0.16±0.39 mm in the balloon group and 0.22±0.40
mm in the RA group (P=0.21, P=0.02 for noninferiority).

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 Shah et al Calcium Modification in PCI
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Figure 4. Calcium modification treatment algorithm.

A guide to calcium modification strategy based upon angiographic and intracoronary imaging analysis. CB indicates cutting balloon; IVL,
intravascular lithotripsy; IVUS, intravascular ultrasound; NCB, noncomplaint balloon; OCT, optical coherence tomography; PCI, percutaneous
coronary intervention; and SB, scoring balloons.

Target lesion revascularization (7% versus 2%; P=0.17),
definite or probable stent thrombosis (0% versus 0%;
P=1.00), and TVF (8% versus 6%; P=0.78) were low and
not significantly different between the 2 groups. This reaf-
firmed that modification balloons were an acceptable and
safe alternate strategy when compared directly to RA in
selected lesions, with no signal of increased procedural
complications.29
One of the limiting factors with the use, and uptake, of
CB’s has been the difficulty in delivering, the historically
bulky, devices. However, CB technology has been sig-
nificantly iterated upon in recent years, with the develop-
ment of devices such as the Wolverine balloon (Boston
Scientific). This CB and catheter has been re-engineered,
with bench testing suggesting a lower profile lesion entry
profile (0.017′′ versus 0.021′′), and mid-balloon profile
(0.036′′ versus 0.042′′) balloon in addition to a more
deliverable catheter (which can be used in a 5F guiding
system) with improved distal tip flexibility (203.4 ver-
sus 269.8 g/cm) compared with the previous Flextome
(Boston Scientific) device (Figure 5B).
In those with moderate-severe calcific disease, the
image-guided use of CB is likely to be an underused
and potentially useful adjunct in calcium modification
(Figure 6). This could mitigate against the use of more
advanced modification techniques (such as atherectomy)
if employed in the appropriate lesion subset.
Scoring Balloons
Scoring balloons (SB) such as the Angiosculpt (Phillips) or
Lacrosse NSE (Asomedica, Belarus) consist of a semicom-
pliant balloon with 3 to 4 rectangular nitinol-based struts
that encircle the balloon in a helical pattern.30 The SB theo-
retically represents a mechanistic evolution of the CB, with
the attempt of reducing the mechanical trauma exerted on
the vessel wall with focused force inflations, while making

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 Shah et al Calcium Modification in PCI

Figure 5. Technology used in calcium modification.

A, The OPN NC high pressure dual layer balloon rated pressure of 35 bar. Courtesy of OPN (SIS Medical, Switzerland). B, Comparison of
Flextome vs Wolverine Cutting balloon profiles (Courtesy of Boston Scientific). C, Intravascular lithotripsy (IVL) device (Courtesy of Shockwave
Medical). D, The ROTAPRO Rotational Atherectomy System (Courtesy of Boston Scientific). E, The Diamondback 360 Orbital Atherectomy
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system (Courtesy of Cardiovascular Systems Inc). F, The Excimer Laser coronary atherectomy (ELCA) system and catheter (Courtesy of Phillips).

it more deliverable than its predecessor. It is suggested
that by scoring the arterial lumen, risk of coronary artery
dissection is reduced but the degree of luminal expansion
is preserved when compared with a traditional CB.31 An
observational OCT study suggested that the use of SBs
led to successful modification in 68% of lesions, although
there was no comparator arm with standard NCB’s in the
study.32 An early registry (n=60) demonstrated the effec-
tiveness of the Angiosculpt balloon, in both de novo calcific
and fibro-calcific in-stent restenosis, confirming technical
feasibility and safety with a modest ALG in both groups,
(0.7 and 1.64 mm, respectively), with no procedural compli-
cations.33 Further to this, a non-randomized study compared
3 predilation strategies; direct stenting without predilation
(n=145) conventional semicompliant balloon (n=117) and
predilation with the AngioSculpt balloon (n=37). IVUS data
confirmed that minimal stent area was greater in those pre-
dilated with an AngioSculpt balloon (1.17±0.35 mm) com-
pared with direct stenting (0.84±0.4 mm) and conventional
predilation (0.93±0.55 mm, P=0.004).34 However, a study
comparing SB (n=146 lesions) to CB (n=173 lesions) sug-
gested that delivery success rate was in fact significantly
higher with the CB (90.8% versus 79.5%, P=0.006) with
similar ALG on IVUS and OCT (3.2±1.8 versus 3.4±1.9
mm2, P=0.53 and 3.6±1.4 versus 4.1±1.9 mm2, P=0.11,
respectively).35 The PREPARE-CALC trial showed that at
9 months there was no difference in mean in-stent late-
lumen loss with modification balloons (CB/SB) compared
with RA, although no data available pertaining to SB (or

Table 1. Synopsis of Data Highlighting Use of High-Pressure Dual-Layered (OPN) NCB

Average max bal- Procedural

Study Sample size loon pressure, atm success, % Clinical presentation, % Main complications
Díaz et al 17
8 40 75 ACS 62.5/stable 37.5 Nil
Secco et al21 91 37.2 92.3 ACS 16.4/stable 83.6 Nil
Raja et al18 4 30.7 100 ACS 50/stable 50 Nil
Fabris et al 19
16 30 100 ACS 0/stable 100 Edge dissection 4.5%
Felekos et al20 5 38 100 ACS 60/stable 40 Nil

ACS indicates acute coronary syndrome; and NCB, noncompliant balloon.

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 Shah et al Calcium Modification in PCI

Figure 6. Optical coherence tomography (OCT) images of cutting balloon use.

A, Pre-percutaneous coronary intervention OCT image deep (0.90 mm) calcific nodule (lower left quadrant) encroaching on vessel lumen.
Minimal luminal area in this segment is 3.51 mm2. B, OCT image immediately following 1:1 sized cutting balloon, showing improved minimal
luminal area (7.52 mm2) and signs of vessel preparation with balloon-associated dissection evident (at 7 and 9 o’clock).

CB) efficacy per se, with the inference made that they
could be used interchangeably.
Intravascular Lithotripsy
The newest addition to the balloon-based armamentarium
is the intravascular lithotripsy (IVL) balloon catheter (Shock-
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with heavy calcification, with a mean diameter stenosis of
73%. The use of the IVL led to an ALG of 1.7±0.6 mm,
with a 6-month MACE of 8.5%, including cardiac death
(n=2 [3%]) and non-Q-wave MI (n=3 [5%]).38 An OCT
sub-group analysis (n=31) showed that the technique is
effective in increasing minimal luminal area (4.16±1.86

wave Medical; Figure 5C).36 The IVL balloon is advanced
over a standard work-horse guidewire. The balloon is sized
with a ratio of 1:1 with the target vessel, when in place
the balloon is inflated to its nominal (low) pressure (4
atm) with up to 80 pulses of energy delivered per balloon.
The mechanism of action is that the energy vaporizes the
saline/contrast mixture within the balloon and generates
high-amplitude ultrasonic pressure waves. The waves pref-
erentially effect hard surfaces such as calcium within both
the intimal and medial layers of the vessel. This causes cir-
cumferential fissures or microfractures that improve vessel
compliance and alter lesion morphology (Figure 7) facilitat-
ing expansion of devices such as balloons and stents. The
low-pressure balloon-based technique is theorized to ben-
efit from the lack of a mechanical trauma to the vessel wall,
reducing the risk of arterial complications and, potentially
the intimal injury that is said to occur following high-pres-
sure BA. However, as the technique remains in its infancy
there are limited long-term data to affirm its efficacy and
these theoretical postulations.37
The Disrupt CAD (Shockwave Coronary Rx Litho-
plasty Study in Coronary Artery Disease) was the first
in-man (n=60) trial of the technology with moderate or
severely calcified coronary arteries. There was a 98.3%
device delivery success rate, with 2 patients suffering
coronary dissection (both successfully treated with PCI).
Seventy-eight percent of the lesions were concentric
versus 2.23±1.11 mm2; P<0.01), with no occurrence
of perforation or slow flow/no-reflow.37 Disrupt CAD II
was a larger multi-center trial (n=120), with the use of
IVL leading to an angiographic ALG of 0.83 mm (±0.47
mm). The OCT substudy (n=47) observed that calcium
fractures were seen in 79% of lesions. There was a low
rate (n=7 [5.8%]) of 30-day non-q-wave myocardial
infarction, when compared with the contemporaneously
conducted ORBIT II trial, using orbital atherectomy (OA;
8.8%), suggesting the technique is safe.39 However,
there are a number of issues that have been identified
which require further longitudinal evaluation to determine
their clinical importance. The use of the device can pre-
cipitate ventricular ectopics (shocktopics) and asynchro-
nous cardiac pacing. Shocktopics appear dependent on
the target lesion location, in keeping with mechano-elec-
tric coupling through activation of local stretch-activated
cardiomyocyte channels. These short-lived coronary IVL-
induced captures are a common observation, occurring
at the same time of the ultrasonic impulse generation,
and are not reported to cause any sustained arrhythmia
or adverse clinical events.40 Additionally as the device is
in its first generation, it is less deliverable than a standard
NCB catheter. Although, with the use of supportive guide
catheters and guide extensions this rarely limits deliver-
ability. Moreover, as the IVL balloon emitters create sonic
pressure waves in a circumferential fashion, it has been

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 Shah et al Calcium Modification in PCI

Figure 7. Optical coherence tomography (OCT) image of intravascular lithotripsy.

A, OCT image of 180° arc of calcification (upper right to lower left quadrants) with a thickness of 0.54 mm. B, OCT image after intravascular
lithotripsy showing micro-fractures.35

suggested that effectiveness of this in non-concentri-
cally calcified lesions may be less pronounced. While it
remains a technological advancement in the field, there
are limited medium- or long-term data to support its use
more systematically. Further accrual of observational
data along with planned trials will guide its future use.
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9970 patients, Isogai et al47 retrospectively compared the
relationship between the volume of RA procedures and
major cardiac complications requiring urgent procedures
(covered stent implantation, coronary artery bypass
grafting, or pericardiocentesis) or death. These were
lower (0.29%) in high-volume, compared with (0.72%)

in low-volume, centers. A recent registry reaffirmed

that centers performing greater volume of atherectomy
Coronary Atherectomy
Rotational Atherectomy
RA uses a diamond encrusted elliptical burr (Figure 5D)
passed into the coronary artery over a specialized 0.009
inch guidewire (Rotawire). The burr rotates at speeds
of 140 000 to 220 000 rpm and abrades non-elastic,
fibro-calcified tissue into small particles (<10 μm) while
deflecting off softer elastic tissue. Lesion modification
through debridement creates a smoother luminal sur-
face increasing the luminal diameter, facilitating bal-
loon predilatation, and stent placement (Figure 8).41 The
debris from the lesion passes downstream and cleared
by the reticuloendothelial system.42 Patients undergoing
RA have historically had increased periprocedural and
postprocedural complications, with complication rates
as high as 9.7%.43 Most documented complications are
common to all PCI procedures; however, some risks
are unique to RA including Burr entrapment, RotaWire
fracture, no flow/slow flow, and atrioventricular block
requiring trans-venous pacing. All require careful patient
consent and intraprocedural management.44 The histori- Figure 8. Optical coherence tomography (OCT) image
cally high complication rates have led to misconceptions immediately following the use of a 1.5 mm rotational
atherectomy burr in a balloon uncrossable lesion.
regarding the relative benefit and safety of RA, result- Upper right quadrant shows deep wall calcification with a thickness
ing in the likely underutilization of this effective calcium of 1.11 mm. The lumen (6–12 o’clock) measures exactly 1.50 mm in
modification strategy.43,45,46 In a contemporary cohort of keeping with the burr sized used. Note 2 wire related artefacts.

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 Shah et al
procedures were associated with lower mortality (0.85
[0.76–0.96], P=0.01) and lower rates of PCI failure or
complication requiring coronary artery bypass grafting
(0.67 [0.56–0.79], P<0.001).48 These data reiterate that
with improvements in technology, operator technique,
and center experience, overall complication rates for
RA are low and the procedure is safe. This more current
data juxtaposes data from initial experiences, where the
use of larger burrs to provide more lesion ablation led
to greater no-reflow, vessel dissection, perforation, bra-
dycardia, and periprocedural MI. Modern RA technique
employs the use of smaller burr sizes (aiming for a Burr
to vessel ratio of 0.5–0.7:1) and shorter burring episodes,
encouraging more superficial fibro-calcific lesion abla-
tion limiting endothelial tissue trauma.49 These subtle, but
important, changes in technique, have also meant that
routine employment of temporary venous pacing during
RA cases is not required. The use of as required atropine
to resolve short-lived intraprocedural bradycardia is the
mainstay in contemporary practice.
While technical safety has undoubtedly improved,
the clinical value of adjunctive RA is difficult to ascer-
tain. Clinical trials have shown that routine lesion prepa-
ration with RA does not reduce stent restenosis rates
when compared with standard BA preparation.46,50 A
retrospective UK database (n=221 669) in which 2152
patients (0.97%) underwent RA, demonstrated lower
procedural success and poorer survival, when compared
with BA.43 However, this was confounded by a multitude
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of factors, including the presence of greater disease
complexity; with increased LMS disease (P<0.001) and
a more comorbid cohort, who were older, had a higher
incidence of diabetes, and poorer LV function (P<0.001
for all) in the RA group. Despite this, propensity analysis
demonstrated a significant improvement in survival for
patients with LMS disease who were treated with RA
(hazard ratio, 0.52 [95% CI, 0.35–0.75], P<0.0001), sig-
naling the potential of incremental value in optimal lesion
preparation in those at greatest risk.
There have been 3 seminal randomized trials assess-
ing the utility of RA. The COBRA study (n=502), a multi-
center RCT comparing BA with RA. At 6 months follow-up,
there were no differences in target vessel revasculariza-
tion, with similar restenosis rates (51% BA versus 49%
RA [P=0.33]).51 The ROTAXUS trial then randomized
patients to PCI with TAXUS (Boston Scientific) DES
with or without RA (n=120 in each arm).46 Despite simi-
lar baseline characteristics, significantly more patients
in the standard therapy group crossed over (12.5%
versus 4.2%, P=0.02), resulting in higher strategy suc-
cess in the RA group (92.5% versus 83.3%, P=0.03),
with no difference in procedural risk, with coronary dis-
sections, perforations, and no-/slow-flow phenomena
occurring equally in both groups, although fluoroscopy
times were longer in the RA group. At 9 months, in-stent
late-lumen loss was higher in the RA group (0.44±0.58
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Calcium Modification in PCI
versus 0.31±0.52, P=0.04), despite an initially higher
ALG (1.56±0.43 versus 1.44±0.49 mm, P<0.01). While
not powered for mortality, at 2 years there was no differ-
ence in mortality (29.4% versus 34.3%, P=0.47), MACE
(29.4% versus 34.3%, P=0.47), or target lesion revascu-
larization (13.8% versus 16.7%, P=0.58).
The more recent PREPARE-CALC RCT,29 empha-
sized that the use of RA, compared with balloon-based
strategies (cutting/scoring), was superior in regards to
strategy success (98% versus 81%, P=0.0001) and not
associated with increased intraprocedural or periproce-
dural complication rates.
RA should be considered a facilitative technique in
completing PCI procedures in complex, heavily calcified
lesions (Figure 8). Appropriate operator training, patient
selection, and procedural planning can aid success and
minimize complications in these technically challenging
scenarios.45,46,52–58
Orbital Atherectomy
A relatively recent advancement in the field of atheroab-
lation is OA (Diamondback 360, Cardiovascular systems
Inc), gaining Food and Drug Administration approval in
2013. This device has a burr with a diamond-coated
crown that orbits in an elliptical path within the artery
(Figure 5E), used over a specialist 0.014′′ wire (Viper-
Wire). The crown’s abrasive surface ablates the calci-
fied lumen, the absence of a cutting action theoretically
reduces the chance of vessel perforation and produces
smaller particles of debris<2 μm. Moreover, unlike RA,
there is continuous blood flow through the artery during
ablation. These features potentially reduce the likelihood
of slow-flow/no reflow, decrease thermal injury during
the procedure and obviate the need for the routine use of
temporary pacing during OA. The crown’s orbital diame-
ter expands radially with increasing centrifugal force that
allows the operator to control the depth of the ablation
by varying the speed of the burr. This avoids the need
to change the burr multiple times, increasing procedural
efficiency. However, owing to the elliptical mechanism of
action, OA is contraindicated in vessel diameters <2.5
mm due to increased risk of vessel perforation.
The ORBIT series of trials have assessed the safety
and efficacy of OA. ORBIT I, a prospective, non-random-
ized study (n=50) of de novo calcified coronary lesions,
treated with OA and PCI, with a small number (n=33)
followed up for 5-years.59 There was a 97% index pro-
cedural success rate with 6-month and 5-year MACE
rates of 12.1%, and 21.2% respectively. The subse-
quent prospective, multi-center, single-arm, ORBIT II
trial enrolled 443 patients across 49 US sites.60 Eighty-
eight percent underwent successful PCI with DES after
OA with a cumulative 3-year MACE of 23.5% and target
lesion revascularization of 7.8%. The commonest com-
plications were coronary dissections (3.4%), perforation
(1.8%), and slow flow (0.9%), representing a low rate of
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 Shah et al
adverse events compared with historical controls. The
COAP-PCI registry provided evidence of OA’s safety
profile when compared directly with RA.61 This multi-
center, prospective observational analysis matched 546
patients who underwent OA or RA between 2011 and
2017. MI occurred less frequently with OA compared
with RA (6.7% versus 13.8%, P≤0.01) and there were
no significant differences in procedural complications
between the 2 groups, with OA having a comparable
vessel perforation and dissection rate of 0.4% and 1.3%,
respectively, with a reduced fluoroscopy time (21.9 ver-
sus 25.6 minutes, P≤0.01). The currently recruiting
ECLIPSE RCT, comparing BA/DES with OA/DES will
provide further clarity regarding the utility of OA. Cur-
rent data suggest OA is a safe and effective technique
with acceptable levels of MACE and limited procedural
complications. The device is predominantly used in the
United States, although it has latterly become available
in Asia-Pacific and the Middle East, although there is
currently little exposure to the device for most interven-
tional cardiologists in Europe.
Laser Atherectomy
The Excimer Laser Coronary Atherectomy (ELCA) cathe-
ter (Phillips) generates pulses of short-wave length, high
energy UV light which break carbon bonds in organic
material within the lesion with the heat generated break-
ing apart cellular debris, fragmenting the lesion into
micro-particles, allowing greater luminal expansion. The
Downloaded from http://ahajournals.org by on October 13, 2023
ELCA catheter, comes in sizes of 0.9, 1.4, 1.7, and 2.0
mm, is passed along a standard 0.014′′ work-horse
guidewire. The catheter choice depending on the vessel
diameter and also the consistency of the plaque. The 0.9
mm catheter is most commonly used and can be used in
vessels >2.0 mm in diameter through a 6F guide (Fig-
ure 5F). The main use of ELCA has historically been in
the setting of intracoronary thrombus, to mitigate against
no-reflow. The manufacturer advises against its use in
heavily calcified lesions because of the inconsistent
delivery of UV light energy in calcific lesions potentially
enhancing the likelihood of vessel dissection, though this
often occurs concurrently with significant lesion modi-
fication. While there are no large scale trial data for its
use, increasing case series data suggest that ELCA can
be employed safely and effectively in a number of sce-
narios with fibro-calcific disease including chronic total
occlusion recanalization, debulking native, and vein graft
disease and in the presence of peri-stent calcium in the
setting of in-stent restenosis.62–67 While the routine use
of ELCA is undertaken with a saline infusion, aiming to
remove both blood, and contrast media from the vessel.
Both blood and iodinated contrast media contain non-
aqueous cellular macromolecules, such as proteins which
absorb the majority of delivered laser energy creating
microbubbles which form at the site of energy delivery,
increasing the likelihood of intimal dissection.68 The use
Circ Cardiovasc Interv. 2021;14:e009870. DOI: 10.1161/CIRCINTERVENTIONS.120.009870
Calcium Modification in PCI
of saline permits passage of light from the catheter tip to
the tissue without any interference so no microbubbles
are formed in this milieu. Therefore, a saline flush/infu-
sion technique is used to safely control energy delivery
and minimize dissection risk. However, the application of
ELCA with a contrast media injection is performed in cer-
tain specific situations to increase the energy delivered,
such as in the treatment of an underexpanded stent or
heavily calcified disease, although this should only be
undertaken by experienced laser operators.
Although ELCA therapy has been available for >2
decades, with significant penetrance within the United
States, uptake and access remains relatively limited in
many other health care systems around the world. Its
lack of widespread clinical use is partly due to perceived
complexity surrounding its use, for example, operators
and staff have to wear additional eye-protection (to pre-
vent retinal exposure to UV light) and the equipment
itself is expensive, particularly if only used sparingly for
PCI cases. ELCA is, therefore, a technique that has a
paucity of data, but may be of use in a number of care-
fully selected clinical scenarios, with image guidance aid-
ing lesion identification (Table 2).
Atherectomy Versus Balloon-Based Calcium
Modification
The decision relating to which modification technique
to use is based on numerous anatomic and technical
factors, including the location of the lesion, the concen-
tricity of the calcium pool, operator familiarity/expertise,
and local device availability. Figure 4 provides a guide
for which devices may be used in the setting of varying
degrees of calcific disease. The decision as to which
device is employed should be guided by intracoronary
imaging, which will reduce uncertainty and clarify which
type of device is most appropriate for the lesion/vessel
in question.
Table 2. Table Highlighting the Characteristics of the 3
Atheroablative Strategies (RA, OA, and Laser) and Their
Indications in Different Clinical Scenarios
Rotational Orbital Laser
Balloon uncrossable +++ ++ ++
Nondilatable lesion +++ +++ +
Eccentric calcium + ++ …
Rapid exchange … … +++
6F guide* ++ +++ ++
Underexpanded stent + + ++
RA: Burr sizes 1.25–1.5mm can be used via a 6F guide. Burr sizes 1.75–
2.0mm require a 7F guide and >2.0mm burr requires an 8F guide. OA is a single
sized catheter which is compatible with 6F a system. ECLA: 0.9 mm catheter
is used via a 6F guide, 1.4 mm is 6/7F and 1.7 and 2.0 mm require 7F and
8F, respectively. ECLA indicates Excimer Laser Coronary Angioplasty; OA, orbital
atherectomy; and RA, rotational atherectomy.
*6F compatibility.
May 2021 565
 Shah et al
In instances of balloon uncrossable lesions, the initial
modification device is likely to be with either RA or OA,
which will alter the lesion morphology sufficiently to allow
other devices to be used (Figure 8). However, there are
often circumstances where a single modification tech-
nique is not sufficient to adequately prepare a lesion
before stent implantation. The systematic use of imag-
ing during a procedure to determine the success of a
technique, both in respect to ALG and calcium fractures
is important to understand whether the technique has
sufficiently modified the lesion, guiding whether another
device is required, and which subsequent device may be
of most benefit.
In lesions with >180° calcium arc which allow initial
passage of NCB balloons, but subsequently show signs
of underexpansion or dog-bone appearance, escalation
to another balloon-based strategy would be advisable.
Depending on the lesion morphology one or more of
high-pressure NCB’s, IVL, or CB’s are likely to be useful
options. In lesions with increased calcium concentricity
(>270° arc), IVL may be of additive benefit, based upon
the early data accrued thus far.
CONCLUSIONS
As the breadth and complexity of calcific coronary dis-
ease treated with PCI increases, the use of adjunctive
devices to ensure optimal stent implantation is key for
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iterative improvement in terms of both technical and
clinical outcomes. There are a number of effective tech-
niques available, ranging from balloon-based strategies
including the recently developed IVL balloon, to ath-
eroablative solutions such as rotational, orbital, and laser
atherectomy. The systematic use of intracoronary imag-
ing is key to improving our understanding about lesion
morphology and to provide guidance about the choice of
modification strategy on a case by case basis and may
promote improved technical success and patient safety.
ARTICLE INFORMATION
Affiliations
University College London, United Kingdom (M.S., O.N.). Royal North Shore Hos-
pital, Sydney, Australia (R.B.). St. Thomas' Hospital, Guy's & St. Thomas' NHS
Foundation Trust, King's College London, United Kingdom (K.D.S.).
Sources of Funding
None.
Disclosures
None.
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