Received: 8 December 2022 | Revised: 23 January 2023 | Accepted: 7 February 2023

DOI: 10.1002/ccd.30603

ORIGINAL ARTICLE ‐ BASIC SCIENCE

Cutting balloon to optimize predilation for stent implantation:

The COPS randomized trial

Antonio Mangieri MD1 Roberto Nerla MD2

| | Fausto Castriota MD2 |
Bernhard Reimers MD1 | Damiano Regazzoli MD1 | Pier P. Leone MD1 |
Gabriele L. Gasparini MD1 | Arif A. Khokhar BM, BCh3 |
4 2
Alessandra Laricchia MD | Francesco Giannini MD | Fulvio Casale MD5 |
Andrea Bezzeccheri MD5 | Carlo Briguori MD, PhD5 | Antonio Colombo MD6,7

1
Department of Cardio Center IRCCS,
Humanitas Research Hospital, Rozzano, Italy Abstract
2
Department of Cardio‐Thoracic GVM Care Objectives: The objective of this study is to investigate the use of cutting balloon
and Research, Maria Cecilia Hospital,
Cotignola, Italy
(CB) inflated at high pressure compared with noncompliant balloon (NCB) for the
3
Department of Cardio‐Thoracic Cardiology treatment of calcified coronary lesions.
Service, Imperial College Healthcare NHS Background: No data are available regarding the safety and efficacy of CB inflated at
Trust, London, UK
4
high pressure in coronary artery calcifications.
Department of Cardiovascular, ASST Santi
Paolo Carlo, Milano, Italy Methods: Patients with calcified lesions (more than 100° of calcium demonstrated at
5
Department of Cardiology, Mediterranea baseline intravascular ultrasound) were randomized. Primary endpoint of the study
Cardiocentro, Naples, Italy
was the final minimal stent area (MSA) and stent symmetry in the calcific segment.
6
Department of Biomedical Sciences,
Secondary endpoints included rate of device failure and the 1‐year rate of target
Humanitas University, Milan, Italy
7
Department of Cardiology Cardio Center
lesion revascularization, target vessel revascularization, and major adverse cardio-
IRCCS, Humanitas Research Hospital, vascular events.
Rozzana, Italy
Results: From September 2019 to June 2021, a total of 100 patients were included
Correspondence and randomized; 13 patients were excluded for major protocol deviations. Lesions
Antonio Mangieri, MD, Cardio Center, were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a
Humanitas Research Hospital, Rozzano, Italy.
Email: antonio.mangieri@gmail.com calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when
compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per‐protocol population,
Funding information
The trial was supported by a research grant the final MSA at the level of the calcium site was significantly higher in the CB group
provided by Boston Scientific (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB
group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB
group. One‐year follow‐up outcomes were comparable.
Conclusions: Treatment of calcified lesions with high‐pressure CB has a good safety
profile and is associated with a larger MSA and higher eccentricity of the stent at the
level of the calcium site compared with NCB.

Abbreviations: CAC, coronary artery calcification; CB, cutting balloon; DES, drug‐eluting stent; IVUS, intravascular ultrasound; MACE, major adverse cardiovascular event; MSA, minimal stent
area; NCB, noncompliant balloon; PCI, percutaneous coronary intervention; TLR, target lesion revascularization.

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any
medium, provided the original work is properly cited and is not used for commercial purposes.
© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

798 | wileyonlinelibrary.com/journal/ccd Catheter Cardiovasc Interv. 2023;101:798–805.


MANGIERI ET AL.
KEYWORDS
coronary calcifications, cutting balloon, intravascular ultrasound imaging, percutaneous
coronary intervention, percutaneous transluminal coronary angioplasty
1 | INTRODUCTION
Coronary artery calcifications (CACs) have been extensively studied
as a marker of poor prognosis in patients with coronary artery disease
and represent a challenge to percutaneous coronary interventions
(PCIs) by limiting stent expansion and increasing the probability of
stent failure at follow‐up.1,2 In the modern PCI era, a number of
calcium modification techniques have been introduced with variable
success, with the aim to improve acute and long‐term outcomes of
PCI. Recent data suggest that the use of the novel cutting balloon
(CB) offers a good safety and efficacy profile in CAC.3 The actual
recommendation for the usage of CB suggest inflations at nominal
pressures. This strategy may lower the efficacy of this device.
Inflating CB at higher pressure may increase its effectiveness in the
treatment of calcified lesions, whereas downsizing its size may
preserve safety. Data comparing CB inflated at high pressure instead
of nominal pressure as reported by previous studies in CAC are
lacking.
2 | M E TH O D S
The Cutting Balloon to Optimize Predilatation for Stent Implantation
(COPS) study is a prospective, randomized, multicenter open‐label
trial, which enrolled patients with significantly calcified lesions (more
than 100° of calcium demonstrated at baseline intravascular
ultrasound [IVUS]) to predilation with either a CB (Wolverine, Boston
Scientific) inflated at high pressure or noncompliant balloon (NCB).
The COPS trial was supported by an institutional grant by Boston
Scientific, who had no responsibility for study management, data
collection, and monitoring. The principal investigators (AM and AC)
conceived the study and developed the protocol. The first draft of
the manuscript was prepared by the first author (AM). The sponsor
could not require changes to the manuscript.
The trial protocol was approved by the ethics committee of the
Area Vasta in Emilia‐Romagna and thereafter by the ethics commit-
tees and institutional review boards of each participating center. All
patients provided written informed consent.
2.1 | Study population and randomization
Patients were enrolled at three participating centers in Italy between
September 2019 and June 2021. Broad inclusion criteria were
adopted to enroll a patient population representative of routine
clinical practice. Adult patients (>18 years old) with evidence of
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| 799
severe de novo‐calcified lesions, with a reference vessel diameter
between 2.5 and 4.0 mm, and deemed suitable for PCI, were
evaluated with a baseline IVUS run (OPTICROSS™ HD, 60 MHz,
Boston Scientific) to confirm the presence of a baseline arch of
calcium of at least 100°. In case of lesion uncrossability with IVUS,
predilation using an undersized balloon was allowed. Patients who
met all inclusion criteria and none of the exclusion criteria were
assigned to either a NCB or a CB in a 1:1 fashion (Supporting
Information: Figure 1). Randomization was performed using a
dedicated online platform Research Electronic Data CAPture.
Angiographic and IVUS images were sent to an independent corelab
for independent analysis.
Exclusion criteria were as follows: age < 18 years old, significant
comorbidities precluding clinical follow‐up, contra‐indications to dual
antiplatelet therapy, thrombocytopenia (platelet count < 100,000 ×
109/L), planned major surgery within 1 year, treatment of in‐stent
restenosis, graft stenosis, and thrombotic lesions.
The Wolverine CB is a semicompliant, rapid‐exchange balloon
with three or four microblade mounted on its surface, which facilitate
calcium cracking. Due to the utilization at high pressure, a downsizing
of 0.5 mm compared with the media to media diameter on IVUS was
recommended. If satisfactory dilation of the target lesion was not
achieved with the allocated study device, additional lesion prepara-
tion techniques could be utilized at the discretion of the operator. In
the NCB arm, a predilatation using a vessel to balloon ration of 1:1
was recommended.
Crossover to the nonassigned device was not permitted.
Following lesion preparation, stenting with new‐generation drug‐
eluting stents (DESs) was performed. After stent optimization, a final
IVUS run was mandatory.
2.2 | Endpoints and definitions
The primary endpoint of the study was the minimal stent area (MSA)
at the level of the calcified segment and was defined as the smallest
cross‐sectional area of the DES in correspondence to the calcified
lesion. Secondary endpoints included the following: (i) stent symme-
try expressed as eccentricity index at the calcium site as previously
reported4; (ii) overall MSA; (iii) device success: defined as successful
device delivery, inflation with adequate lesion preparation, and the
absence of vessel rupture/perforation. Other investigated endpoints
were the incidence of vessel perforation, the rate of major adverse
cardiovascular events (MACEs), and target lesion revascularization
(TLR) at 1‐year follow‐up. Vessel rupture was categorized according
to the Ellis classification.5
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800 | MANGIERI ET AL.

2.3 | Sample size calculations and statistical end of the procedure a significant difference in minimal lumen area
analysis plan was found (CB 3.4 ± 1.1 mm2 vs. NCB 3.0 ± 0.7; p = 0.02) without any
difference of reference vessel diameter and percentage of stenosis
Assuming a mean and SD of MSA at calcium site of 5.0 ± 1.5 mm for (Table 2). In most of the cases, the target vessel was the left
the high‐pressure CB lesion preparation versus 4.0 ± 1.5 mm two for descending anterior artery.
the NCB,6 a sample size of 36 patients per group was calculated to Table 3 reports the procedural features. CB and NCB were
meet the primary endpoint requirements with a power of 80% and a inflated at similar pressures. No difference was observed in stent
two‐sided α‐level of 0.05. length and diameter; a similar rate of postdilation was detected
The sample size proposed was 50 patients in each group to between the two groups. All the lesion were successfully treated with
further increase the power and account for possible protocol the device study and no need for addiction devices was required.
deviations. The endpoint was estimated according to a previous
study with more restricted values related to our primary endpoints,
which is the MSA at the level of the calcium site. Primary and 3.1 | Post‐PCI IVUS data analysis
secondary endpoints were analysed per protocol. Categorical data
were expressed as counts and proportions. Differences between Table 4 shows the IVUS findings in the per‐protocol population. The
groups were checked for significance using the χ2 test (or Fisher's use of CB yielded to a higher MSA at calcium site (CB 8.1 ± 2 mm2 vs.
exact test when the expected cell value was <5). Continuous data
were showed as mean ± SD and compared using the Student's t test
TABLE 1 Baseline demographics of the per‐protocol population.
or Mann–Whitney U test, as appropriate. All tests were two‐sided
and a p < 0.05 was considered statistically significant. Data were Overall CB NCB
87 44 43 p
analysed with STATA software version 15.0 (Stata Corporation).
Age 71 ± 7.6 70.8 ± 6.7 72.5 ± 4.3 0.35

Female sex 16 (18.3) 11 (25) 5 (11.6) 0.166

3 | RESULTS
Hypertension 70 (82.3) 31 (73.8) 39 (90.7) 0.051

Diabetes 29 (34.5) 16 (39.2) 13 (30.2) 0.491

From September 2019 to June 2021, a total of 100 patients at 3 sites
in Italy were included and randomized; 13 patients (n = 6 in the CB Hypercholesterolemia 63 (73.2) 30 (71.4) 33 (75) 0.809
group and n = 7 in the NCB group) were excluded for major protocol Prior MACE 4 (4.71) 2 (4.8) 2 (4.5) 0.874
deviations. In details, all patients excluded from the final analysis had
Chronic renal failure 9 (10.4) 6 (14.2) 3 (6.8) 0.258
an arch of calcium <100° (mean arch of calcium in the excluded
Previous PCI 22 (25.8) 11 (26.2) 11 (25.5) 0.49
population 69.2 ± 22°, calcium length 3.19 ± 2.7 mm). Final per‐
protocol population consisted of 87 patients allocated to CB Previous CABG 10 (11.6) 4 (9.5) 6 (13.6) 0.739
(n = 44) or NCB (n = 43) (Figure 1). LVEF (%) 54 ± 5.6 55 ± 8.8 53 ± 3.9 0.343
The baseline features of the two populations were comparable
UA/NSTEMI 5 (5.9) 4 (10.0) (2.2) 0.187
with no significant differences (Table 1). The vast majority of the
lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of Abbreviations: CABG, coronary artery bypass grafting; CB, cutting
balloon; LVEF, left ventricular ejection fraction; MACE, major adverse
calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm and deep
cardiovascular events; NCB, noncompliant balloon; NSTEMI,
calcium detected in 29.4% of the lesions. Total lesion length was non‐ST‐elevation myocardial infarction; PCI, percutaneous coronary
24.3 ± 9.7 mm without differences between the two groups. At the intervention; UA, unstable angina.

F I G U R E 1 Study flow chart. CB, cutting

balloon; NCB, noncompliant balloon. [Color figure
can be viewed at wileyonlinelibrary.com]
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MANGIERI ET AL. | 801

TABLE 2 Baseline angiographic features of the per‐protocol TABLE 3 Baseline procedural features of the per‐protocol
population. population.

Overall CB NCB Overall CB NCB

n = 87 n = 44 n = 43 p n = 87 n = 44 n = 43 p

Vessel location 0.6 Predilatation 18.6 ± 4.7 18.3 ± 5 19 ± 4.5 0.463

atmospheres
RCA 25 (28.7) 14 (32) 11 (25)
Diameter of the balloon 3.1 ± 0.4 3.02 ± 0.3 3.2 ± 0.4 0.031
LAD 51 (58.6) 26 (59.1) 26 (60.3)
for predilation
LM 2 (2.3) 1 (2.3) 1 (2.2)
Balloon to artery ratio 0.89 ± 0.2 0.86 ± 0.1 0.92 ± 0.2 0.057
CX 7 (8.1) 2 (4.6) 5 (11.3)
Number of stent 1.3 ± 0.4 1.3 ± 0.5 1.2 ± 0.4 0.314
Ramus 1 (1.5) 0 1 (2.2) implanted

Vessel segment 0.611 Total stent length (mm) 32.9 ± 12 31.6 ± 12 34.2 ± 12 0.837

Ostial 7 (8) 4 (9.3) 3 (6.8) Stent diameter (mm) 3.3 ± 0.4 3.4 ± 0.3 3.3 ± 0.4 0.737

Proximal 55 (63.2) 28 (65.1) 27 (61.3) Postdilatation 67 (77) 33 (75) 34 (79) 0.885

Mid 24 (27.5) 10 (23.2) 14 (31.8) Diameter of the balloon 3.5 ± 0.5 3.6 ± 0.6 3.5 ± 0.4 0.497
for postdilation
Distal 1 (1.1) 1 (2.3) 0
Postdilatation 20.9 ± 0.6 20 ± 5.2 21.7 ± 5.4 0.201
Type of lesions 0.484
atmospheres
Type A 0 0 0
Abbreviations: CB, cutting balloon; NCB, noncompliant balloon.
Type B1 25 (28.7) 14 (32.5) 11 (25)

Type B2/C 62 (71.2) 29 (67.4) 33 (75)

TABLE 4 IVUS findings in the per‐protocol population.
IVUS evaluation
Overall CB NCB
Calcium distribution 0.482 n = 87 n = 44 n = 43 p

Mixed calcium 34 (40) 15 (34.8) 19 (45.2) 2

Final MSA (mm ) 6.8 ± 1.9 7.1 ± 1.7 6.5 ± 2.1 0.116

Deep calcium 25 (29.4) 15 (34.8) 10 (23.8) Minimal Stent Diameter 2.6 ± 0.4 2.7 ± 0.4 2.5 ± 0.4 0.064
Superficial calcium 26 (30.5) 13 (30.2) 13 (30.9) Maximal Stent Diameter 3.2 ± 0.4 3.2 ± 0.4 3.1 ± 0.4 0.189
Arch of calcium 266 ± 84 274 ± 84 258 ± 85 0.373 Final MSA at calcium site 7.7 ± 2.1 8.1 ± 2 7.3 ± 2.1 0.035
(degrees)
Minimal stent diameter 2.8 ± 0.5 2.9 ± 0.7 2.7 ± 0.4 0.016
Calcium 12 ± 6.6 11.9 ± 7.3 12.5 ± 6 0.667 at calcium site
length (mm)
Maximal stent diameter 3.4 ± 0.4 3.5 ± 0.5 3.3 ± 0.4 0.132
Lesion length (mm) 24.3 ± 9.7 23.5 ± 9.6 25.1 ± 9.8 0.442 at calcium site
Minimal lumen 3.2 ± 0.9 3.4 ± 1.1 3 ± 0.7 0.02 Eccentricity index at 0.82 ± 0.8 0.84 ± 0.7 0.8 ± 0.8 0.013
area (mm2) calcium site
QCA evaluation Abbreviations: CB, cutting balloon; IVUS, intravascular ultrasound; MSA:
Reference vessel 3.4 ± 0.4 3.51 ± 0.3 3.39 ± 0.4 0.112 minimal stent area; NCB, noncompliant balloon.
diameter (mm)

Percentage of 81.2 ± 8.1 79.4 ± 7.6 82.7 ± 8.3 0.97

stenosis (%)
to treat analysis (Supporting Information: Table 1), a trend toward a
higher MSA at calcium site was observed in patients treated with CB.
Abbreviations: CB, cutting balloon; CX, circumflex artery; IVUS,
In the subgroup analysis, the benefit of the CB was more evident
intravascular ultrasound; LAD, left descending artery; LM, left main; MSA,
minimal stent area; NCB, noncompliant balloon; QCA, quantitative among patients with evidence of more than 270° arc of calcium
coronary angiography; RCA, right coronary artery; TLR, target lesion (Figure 2C).
revascularization.

3.2 | Clinical and outcomes data

NCB 7.3 ± 2.1 mm2, p = 0.035) and a higher eccentricity index
(0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013) (Figure 2A,B). Differences were In the CB arm, three device failures occurred (6.8%): one lesion
also observed in terms of minimum stent diameter, which was higher preparation required rotational atherectomy to advance the CB that
in the CB group (2.9 ± 0.7 mm vs. 2.7 ± 0.4, p = 0.016). In the intention was finally utilized; two patients had an Ellis type‐1 perforation,
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802 | MANGIERI ET AL.

F I G U R E 2 Main findings of the study: significant difference between cutting balloon (CB) and noncompliant (NC) balloon in terms of minimal
stent area (MSA) (A) and stent symmetry (B) at the level of calcium site. Results are presented as mean and SD. A benefit of CB was observed in
lesions with more than 270° of calcium. [Color figure can be viewed at wileyonlinelibrary.com]

which were managed with one covered stent and one DES 4 | D IS CU SS IO N
implantation, respectively. In one case, the perforation was related
to an inadequate CB downsizing compared with the vessel media to The main findings of this randomized controlled trial comparing CB with
media diameter, whereas in the other case the perforation occurred NCB are as follows: (1) treatment of calcified lesions with high‐pressure
in the presence of a large calcified nodule. No intrahospital deaths CB results in a larger MSA and more symmetric expansion of the stent at
occurred. the level of the calcified segment compared to NCB (Graphical abstract);
At 1‐year follow‐up, outcomes were comparable between the (2) the use of CB compared with standard NCB angioplasty appears to be
two groups (Table 5). The overall MACE rate was 3.4%; three TLRs safe when undersized and inflated at high pressure with low rate of
were reported at follow‐up (CB n=1 [1.1%]; NCB n=2 complications; (3) the benefit of lesion preparation with CB is magnified in
[4.6%], p = 0.49). the presence of significant calcifications more than 270°.
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MANGIERI ET AL. | 803

T A B L E 5 Periprocedural and 1‐year outcome of the per‐ producing calcium fractures in multiple planes. Calcium fracture is the
protocol population. likely mechanism through which intravascular lithotripsy enhances
Overall CB NCB vessel compliance to facilitate optimal stent expansion.14
n = 87 n = 44 n = 43 p Previous studies have evaluated the performance of the old
Device failure 3 (3.4) 1 (6.8) 0 (0) 0.517 generation of CB (Flexotome, Boston Scientific) compared with NCB
in the context of calcified coronary lesions. The article by Tang et al.6
Additional use of rotational 1 (1.1) 1 (2.2) 0 (0) 0.79
atherectomy enrolled 97 patients and concluded that the use of CB in patients
with calcified lesions resulted in an increased MSA, stent apposition,
Ellis type‐1 vessel rupture 2 (2.2) 2 (4.4) 0 (0) 0.189
stent symmetry, and expansion. A recent, elegant study based on
Implantation of a covered 1 (1.1) 1 (2.2) 0 (0) 0.65
optical coherence tomography in severely calcified lesions has
stent
demonstrated that although NCB, orbital, and rotational atherectomy
Final TIMI flow > 3 87 (100) 44 (100) 43 (100) 0.854 does not generate cracks within the calcium, CB is able to create
1‐Year follow‐up fractures in 43.3% of cases with more than one crack observed in
Deaths 3 (3.4) 1 (1.1) 2 (4.6) 0.342 more than 76% cases. The receiver‐operating curves identified that
the best predictors of CB efficacy were a maximum calcium arch of
Cardiac deaths 1 (1.1) 0 (0) 1 (2.3) 0.887
198°, a minimum calcium thickness of 0.445 mm, and a balloon‐artery
Stroke 0 (0) 0 (0) 0 (0) 0.91
ratio of 2.1.15 Another large series of 261 de novo‐calcified lesions
TLR 3 (3.4) 1 (1.1) 2 (4.6) 0.49 treated with only NCB found the presence of calcium fracture in
Abbreviations: CB, cutting balloon; NCB, noncompliant balloon; TIMI, 10.7%.16 These results support our findings that highlight the efficacy
thrombolysis in myocardial infarction; TLR, target lesion revascularization. of CB inflated at high pressures at the level of calcium site to obtain
better stent expansion and symmetry. Moreover, these data support
the use of CB particularly in more extended arch of calcium. As
CACs still represent a challenge for modern PCI and their demonstrated by our subanalysis, the benefit of high‐pressure CB is
presence in the context of coronary artery disease is a marker of more evident among patients with more than 270° of calcium,
adverse prognosis.7 The extension of coronary calcifications corre- whereas no apparent advantages of CB over NCB are evident in less
lates with the severity of coronary artery disease with spotty pronounced arch of calcium.
calcifications more common in unstable patients, whereas extensive Even if some complications have been reported following the use
calcifications are more common among stable patients.8 Angiograph- of CB, in our study we had only two type‐1 Ellis perforations, which
ically visible plaques are usually thick, extended in length, and may did not have a subsequent impact on the patient's clinical outcome. In
hinder correct stent expansion in the absence of appropriate lesion one case, the perforation occurred in the mid left descending artery
preparation.9 As a matter of fact, PCI in calcified coronary artery where a 3.25 mm CB was inflated at 16 atmospheres in a vessel with a
lesions is associated with impaired stent delivery, asymmetrical stent media to media diameter of 3.5 mm and high plaque burden. In this
expansion, increased periprocedural complications, and unfavorable case, it is possible that the downsizing of the CB was not enough in
1,10
long‐term clinical outcomes. To overcome these technical issues, relation to the vessel diameter and the high amount of disease. In the
new interventional tools such as orbital, rotational atherectomy, and other case, vessel damage occurred in the proximal left descending
lastly intravascular lithotripsy have been introduced to improve lesion artery where a nodule of calcium was present; in this latter case, it is
preparation in presence of CAC.11 CB is a technology which has been possible that the inflation of CB created an asymmetric dilation with
used for years in the treatment of de novo‐calcified lesions and consequent rupture of the vessel in the portion with less resistance. To
restenosis. The CB has characteristic longitudinal microblades minimize the risk of vessel rupture, we encouraged the operators to
mounted over the external surface of a low compliance balloon, undersize the CB of 0.5 mm compared with the media to media vessel
which guarantee an increased resistance to balloon deformation even diameter while performing an IVUS evaluation of the correct vessel
at high pressures.12 Moreover, the microblades stabilize the balloon size. Moreover, even if some concerns exist about the lower
position during inflation, facilitating a more precise and controlled crossability and trackability of CB compared with NCB, in only one
inflation to deliver the required pressure at the intended lesion site. case rotational atherectomy was required to favor the advancement of
Elegant simulation model has clearly underlined that secured the study device. Similar rate of complications was reported in the
atherotomes amplify force in calcium, thus generating a higher stress ISAR‐CALC (super high‐pressure balloon vs. scoring balloon to prepare
level in calcifications compared with NC balloon; moreover, CB severely calcified coronary lesions) study in which scoring balloon was
distinctly reduces the stress levels at the border of the artery compared to super NCB in severely calcified lesions. The latter study
adjacent to the calcification compared with conventional balloons demonstrated a coronary perforation rate of 2.7% in both groups of
13
potentially reducing the rate of flow‐limiting dissections. A possible treatment.17 Nevertheless, in the ISAR‐CALC trial, the rate of
alternative to CB in CAC is represented by intravascular lithotripsy. adjunctive rotational atherectomy was higher (8.7% in both the arms)
However, the mechanism of action is different, as it is based on the compared with our study, which is possibly related to an unsatisfactory
emission of acoustic pressure waves in a transmural fashion, thus lesion preparation of to an difficult deliverability of the study devices.

804 | MANGIERI
4.1 | Limitations
There are a number of limitations that should be taken into account
as follows:
‐ The study was performed in calcified lesions in which device
crossability can be hampered. To perform baseline IVUS run,
operators could predilatate the lesion with undersized balloons to
facilitate the delivery of devices. This adjunctive maneuver could
have biased the baseline IVUS findings.
‐ The open‐label nature of the study could have potentially created
some bias in the treatment methodology. In particular, some
operators were not confident in using the CB at high pressure and
this could have had a potential influence on the study results.
‐ Potentially interesting variables such as fluoroscopy time, amount
of contrast, and some other complications such as periprocedural
myocardial infarction are not reported in the database, thus
potentially limiting the information about procedural complexity.
5 | C ONC LUS I ON S
Treatment of calcified lesions with high‐pressure CB shows an
acceptable safety profile and yielded a larger MSA and lower
eccentricity of the stent at the level of the calcified segment
compared with NCB. Larger studies are needed to confirm our
findings.
A C KN O W L E D G M E N T S
We thank Dr. Satoru Mitomo for the study design and realization.
Open access funding provided by BIBLIOSAN.
CO NFL I CT OF INTERES T S T ATEME NT
Antonio Mangieri received speaking honoraria from Boston Scientific
and Abbott Vascular; received fees and speaking honoraria from
Concept Medical and an Istitutional grant from Boston Scientific.
Fausto Castriota is a proctor for Medtronic and Boston Scientific.
Damiano Regazzoli received speaking honoraria from Boston
Scientific, Medtronic, Terumo, Cordis, Concept Medical. Gabriele L.
Gasparini reports consulting/speaker/proctoring honoraria from
Terumo, Asahi Intecc, IMDS, Boston Scientific, Medtronic, Abbott
Vascular, and Cardinal Health. Francesco Giannini received consulting
fees from Boston Scientific. Other authors reported no significant
conflict of interest.
I M P A C T O N D A I L Y PR A C TI C E
Treatment of coronary calcified lesions can be a challenge and is
associated with a higher risk of stent failure. In calcified lesion, the use
of high‐pressure CB compared with NCB balloon results in a larger
MSA and more symmetric stent expansion with similar safety profile.
This finding can have a deep impact on the daily practice, as CB use can
help to optimize the PCI result in calcified coronary lesions.
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ET AL.
ORC I D
Antonio Mangieri http://orcid.org/0000-0002-3239-4046
Roberto Nerla http://orcid.org/0000-0002-9065-3261
Pier P. Leone http://orcid.org/0000-0002-0561-4760
Arif A. Khokhar http://orcid.org/0000-0002-4455-2865
Francesco Giannini http://orcid.org/0000-0002-3391-9860
Andrea Bezzeccheri http://orcid.org/0000-0002-7207-8953
Carlo Briguori http://orcid.org/0000-0002-2105-8186
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How to cite this article: Mangieri A, Nerla R, Castriota F,
2018.02.004
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