969681

research-article2020
JETXXX10.1177/1526602820969681Journal of Endovascular TherapyJia et al

A SAGE Publication

Clinical Investigation

Journal of Endovascular Therapy

Drug-Coated Balloon Angioplasty

1­–7
© The Author(s) 2020
Article reuse guidelines:
Compared With Uncoated Balloons sagepub.com/journals-permissions
DOI: 10.1177/1526602820969681
https://doi.org/10.1177/1526602820969681

in the Treatment of Infrapopliteal www.jevt.org

Artery Lesions (AcoArt II–BTK)

Xin Jia, MD1* , Baixi Zhuang, MD2*, Feng Wang, MD3*, Yongquan Gu, MD4*,
Jiwei Zhang, MD5, Xinwu Lu, MD6, Xiangchen Dai, MD7, Zhaoyu Liu, MD8,
Wei Bi, MD9, Changwei Liu, MD10, Shenming Wang, MD11,
Francesco Liistro, MD12, and Wei Guo, MD1

Abstract
Purpose: To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the
treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).
Materials and Methods: The prospective, multicenter, randomized study AcoArt II–BTK study (ClinicalTrials.gov identifier
NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age
70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no
significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion
length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-
quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality
and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results: Primary patency at 6
months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm
for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group
vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53).
Conclusion: This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions,
with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher
primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the
uncoated balloons after 1 year of follow-up.

Keywords
anterior tibial artery, balloon angioplasty, below-the-knee artery, chronic limb-threatening ischemia, chronic total occlusion,
drug-coated balloon, mortality, patency, randomized clinical trial, target lesion revascularization

Introduction artery lesions using the Orchid DCB (Acotec Scientific)

The treatment of femoropopliteal artery lesions with drug-
coated balloons (DCBs) has been shown to be superior to
conventional balloon angioplasty with uncoated balloons in
terms of clinical efficacy.1–5 However, the role of DCBs in
the revascularization of occluded infrapopliteal arteries is a
matter of ongoing controversy. Randomized trials evaluat-
ing the performance of DCBs vs uncoated balloons in this
vascular territory have yielded inconsistent results.6–10 The
Litos and Tulip DCBs (Acotec Scientific, Beijing, China)
are low-profile balloon catheters coated with paclitaxel, dif-
fering only in their guidewire compatibility. In the AcoArt I
study, positive results were obtained for femoropopliteal
with the same coating formulation.4,5 The purpose of this
trial was to prospectively assess the safety and efficacy of
Litos and Tulip DCBs vs uncoated balloons in the treatment
of infrapopliteal lesions in patients with chronic limb-
threatening ischemia (CLTI).
Materials and Methods
Study Design
The AcoArt II–BTK study was a prospective, multicenter,
randomized controlled trial that sought to assess the safety
and efficacy of Litos or Tulip DCBs vs uncoated balloons
2 Journal of Endovascular Therapy 00(0)

(control) for patients with stenotic or occlusive infrapopli- Study Devices

teal lesions. The main inclusion criteria were single or
sequential de novo or restenotic lesions with >70% diam-
eter stenosis in the infrapopliteal arteries, at least 1 patent
runoff vessel to the foot, Rutherford category 4 to 6 isch-
emia, and a maximum of 2 different arteries to be treated in
the same limb. The main exclusion criteria were acute
thrombosis in the target vessel, planned major amputation
of the target limb, history of open surgery of the target
vessel, the need for intervention in both limbs at the same
time, an existing stenosis or occlusion >150 mm in the
inflow vessels (including the iliac artery, superficial femo-
ral artery, and popliteal artery), and in-stent restenosis. All
patients were randomly assigned to the DCB or control
group (1:1 ratio) by a central randomization computer sys-
tem. Successful guidewire crossing of the lesion was
required for enrollment in the study.
Angiographic outcomes were adjudicated by the Good
Laboratory Practice–certified coreLab Black Forest (Bad
Krozingen, Germany). Measurement was performed using
QAngio XA software (version 7.3; Medis Medical Imaging,
Maastricht, the Netherlands). Clinical monitoring included
100% retraceable source document verification, and all
adverse events were reported to the Beijing Medical
Products Administration. Data management and statistical
analysis were performed by the Medical Research &
Biometrics Center (National Center for Cardiovascular
Diseases, Beijing, China).
This study was sponsored by Acotec Scientific and was
conducted in conformity with the Declaration of Helsinki
and the provisions for the conduct of clinical trials of
medical devices issued by the National Medical Products
Administration. It was approved by the ethics committees of
the Chinese PLA General Hospital and the 10 other partici-
pating hospitals. All patients gave written informed consent
prior to any study procedure. The trial was registered on the
National Institutes of Health website (ClinicalTrials.gov
identifier NCT02137577).
The study devices consisted of both the 0.014-inch wire–
compatible Litos and the 0.018-inch–compatible Tulip
series catheters, which are identical in terms of platform,
drug material, and coating technology. The balloons, which
are coated in an inflated state, are covered with 3-µg/mm2
paclitaxel in a matrix containing magnesium stearate as a
polymer-free natural excipient. Magnesium stearate is a
liposoluble substance that reduces drug loss during the
delivery process, and the unique coating technology enables
paclitaxel to take on the proper crystalline form to ensure
drug retention. The DCBs ranged in length from 20 to 300
mm and were available with diameters of 2 to 4 mm.
Angioplasty Procedure
Candidates meeting the eligibility criteria underwent the
angioplasty procedure according to local standards and at
the discretion of the physician. Upon successful navigation
of the target lesion but prior to randomization, the lesion
was predilated with an uncoated balloon (Amphirion Deep;
Medtronic, Minneapolis, MN, USA), with prolonged infla-
tion (<180 seconds) recommended to reduce flow-limiting
dissection and residual stenosis. After this, the patient was
considered enrolled. Patients randomized to the DCB group
were treated with a Litos or Tulip DCB having the same
diameter as the reference vessel diameter and of sufficient
length to cover the entire target lesion and at least 10 mm
beyond the predilation length. DCB dilation was main-
tained for no less than 60 seconds. Bare metal stents (BMS)
could be placed in cases of flow-limiting dissection and
serious residual stenosis. Other endovascular treatments
were prohibited, including debulking or cutting balloons.
Patients enrolled in the control group had the same proce-
dure with an uncoated balloon (Amphirion Deep) after pre-
dilation. Dual antiplatelet therapy was recommended for no
less than 1 month after the procedure (100 mg/d acetylsali-
cylic acid and 75 mg/d clopidogrel). Clinical follow-up was

1
Chinese PLA General Hospital, Beijing, China
2
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
3
The First Affiliated Hospital of Dalian Medical University, Dalian, China
4
Xuanwu Hospital, Capital Medical University, Beijing, China
5
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
6
The Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
7
Tianjin Medical University General Hospital, Tianjin, China
8
Shengjing Hospital of China Medical University, Shenyang, China
9
The Second Hospital of Hebei Medical University, Shijiazhuang, China
10
Peking Union Medical College Hospital, Beijing, China
11
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
12
Cardiovascular Department, San Donato Hospital, Arezzo, Italy

*Xin Jia, Baixi Zhuang, Feng Wang, and Yongquan Gu contributed equally to this work and have shared first authorship.

Corresponding Author:
Wei Guo, Chinese PLA General Hospital, No. 28 Fuxing Road, Beijing, China.
Email: guoweiplagh@sina.com
Jia et al 3
Figure 1.  Patient flow diagram.
scheduled 30 days, 6 months, and 12 months postopera-
tively; in-hospital angiography was required at 6 months.
Patient Enrollment
Between May 2014 and June 2018, 120 patients were
randomized (Figure 1) to either DCB angioplasty [61
patients/65 lesions (mean age 70.7±7.4 years; 36 men)] or
uncoated balloon angioplasty [59 patients/66 lesions (mean
age 70.8±9.0 years; 36 men)] at 11 centers in China. Table
1 lists the baseline patient characteristics. Most patients had
diabetes and hypertension, and nearly all patients (119/120)
suffered from CLTI (Rutherford category 4–6). The target
lesion lengths were similar (169.95±86.35 mm in the DCB
group and 179.93±80.16 mm in the control group), as were
the proportions of total occlusions (75.0% and 83.1%,
respectively).
Outcomes and Definitions
The primary efficacy outcome was primary patency at 6
months, defined as the absence of target lesion occlusion on
angiography or the need for clinically-driven target lesion
revascularization (CD-TLR) and no major amputation of
the target limb. The follow-up window at 6 months ranged
from 5 to 9 months. The primary safety endpoint was 30-day
major adverse events (MAEs), defined as a composite of
all-cause death, TLR, and major amputation on the target
extremity. Secondary outcomes were (1) device success,
defined as the balloon catheter reaching the target lesion(s),
expanding as expected without leakage, and being with-
drawn successfully; (2) technical success, defined as suc-
cessful vascular access, device success, and completion of
the endovascular procedure with ≤50% residual stenosis
of the treated lesion; (3) the need for CD-TLR within 12
months; (4) late lumen loss (LLL) and transverse-view ves-
sel area loss (TVAL) at 6 months measured on angiography;
and (5) MAEs within 12 months. LLL was defined as the
difference between the minimum lumen diameter (MLD)
immediately after the procedure and the MLD at the
6-month follow-up. TVAL was the percentage of side-view
lumen area lost between the post revascularization (pr)
and follow-up (fu) angiograms, calculated as 100% –
(TVAfu/TVApr).
Statistical Analysis
Continuous variables are presented as the mean ± standard
deviation and were compared using the Student t test or the
Mann-Whitney U test for nonnormally distributed data.
Categorical variables are presented as numbers (percent-
ages) and were compared using the chi-square, Fisher exact,
or Mann-Whitney U test. Survival was estimated using the
Kaplan-Meier method; groups were compared using the log-
rank test. Estimates are presented with the 95% confidence
interval (CI). A 2-sided p<0.05 indicated a significant
4 Journal of Endovascular Therapy 00(0)

Table 1.  Baseline Characteristics of Patients and Lesions Randomized to Treatment With Drug-Coated or Uncoated Balloons.a

DCB Control p
Patients (n=61) (n=59)  
  Age, y 70.7±7.4 70.8±9.0 0.95
 Men 36/61 (59) 36/59 (61) 0.82
  Coronary artery disease 22/61 (36) 20/59 (34) 0.81
 Hypertension 50/61 (82) 44/59 (75) 0.33
 Hyperlipidemia 25/61 (41) 16/59 (27) 0.11
  Diabetes mellitus 45/61 (74) 42/59 (71) 0.75
  Current smoker 16/61 (26) 16/59 (27) 0.60
  Current alcoholic 10/61 (16) 6/59 (10) 0.32
  Rutherford category 0.76
  3 1/61 (2) 0/59  
  4 27/61 (44) 24/59 (41)  
  5 24/61 (39) 28/59 (47)  
  6 9/61 (15) 7/59 (12)  
  Ankle-brachial index 0.56±0.27 0.51±0.31 0.41
Lesions (n=65) (n=66)  
  Chronic total occlusion 48/64 (75.0) 54/65 (83.1) 0.26
  Target vessels 0.34
  TA 1/65 (1.5) 1/66 (1.5)  
  TA+PTA 10/65 (15.4) 4/66 (6.1)  
  TA+PA 5/65 (7.7) 9/66 (13.8)  
  ATA 31/65 (47.7) 33/66 (50.0)  
  PTA 14/65 (21.5) 12/66 (18.2)  
  PA 4/65 (6.2) 7/66 (10.6)  
  Calcification grade 0.328
  0 (none) 9/65 (13.8) 12/66 (18.2)  
  1 (unilateral <5 cm) 17/65 (26.1) 16/66 (24.2)  
  2 (unilateral >5 cm) 0/65 0/66  
  3 (bilateral <5 cm) 22/65 (33.8) 23/66 (34.8)  
  4 (bilateral >5 cm) 8/65 (12.3) 4/66 (6.1)  
  Unknown 9/65 (13.8) 11/66 (16.7)  
  Target lesion length, mm 169.95±86.35 179.93±80.16 0.51
  Reference vessel diameter, mm 2.50±0.37 2.43±0.33 0.28
  Minimum lumen diameter, mm 0.14±0.30 0.07±0.21 0.17
  Diameter stenosis, % 95 97 0.23

Abbreviations: ATA, anterior tibial artery; DCB, drug-coated balloon; PA, peroneal artery; PTA, posterior tibial artery; TA, tibiofibular artery; TVA,
transverse-view vessel area.
a
Continuous data are presented as the mean ± standard deviation; categorical data are given as the number (percentage).

difference. SAS statistical software was employed for all
calculations (version 9.4; SAS Institute, Cary, NC, USA).
Results
Device and technical success rates were 100% in both the
DCB and control groups (Table 2). The mean device diame-
ter was 2.72±0.25 mm in the DCB group and 2.64±0.25
mm in the control group (p=0.07). No bailout stent was
required in the DCB group, while 1 BMS (1.5%, 1/66) was
implanted in the control group. The MLD increased from
0.14±0.30 mm (DCB) and 0.07±0.21 mm (control) before
the procedure to 1.46±0.41 mm and 1.39±0.40 mm, respec-
tively, after treatment.
Efficacy outcomes are presented in Table 3. The pri-
mary patency rates at 6 months were 75.0% in the DCB
group vs 28.3% in the control group (p<0.001), with an
absolute risk reduction of 50%. LLL at 6 months was
0.43±0.62 mm in the DCB group vs 0.99±0.55 mm in the
control group (p<0.001). The TVA of the target lesion at
6 months was 329.79±215.21 mm2 in the DCB group vs
172.46±157.08 mm2 in the control group (p<0.001), and
the TVAL was 11.94%±33.50% vs 54.18%±34.03%,
respectively (p<0.001). MAEs occurred in none of the
Jia et al 5

Table 2.  Procedure Characteristics per Lesion.a

DCB (n=65) Control (n=66) p

Predilation balloon diameter, mm 2.50±0.36 2.43±0.38 0.22
Devices/per lesion 2.2 1.2 <0.001
Inflation time, mm 168.19±30.77 153.40±39.95 0.002
Balloon diameter, mm 2.72±0.25 2.64±0.25 0.07
Minimum lumen diameter post, mm 1.46±0.41 1.39±0.40 0.28
Diameter stenosis, % 41 42 0.66
Bailout stenting 0 1/66 (1.5) 0.32
TVA pre, mm2 133.70±118.31 138.19±99.57 0.82
TVA post, mm2 391.68±204.75 398.08±179.32 0.85
Technical success, % 100 100  
Device success, % 100 100  

Abbreviations: DCB, drug-coated balloon; TVA, transverse-view vessel area.

a
Continuous data are presented as the mean ± standard deviation; categorical data are given as the number (percentage).

Table 3.  Efficacy Outcomes at the 6-Month Angiographic Follow-up.a

DCB Control p
Primary patencyb 36/48 (75.0) 13/46 (28.3) <0.001
Occlusionc 10 26  
CD-TLRd 3 12  
Major amputation 1 1  
Minimum lumen diameter, mm 1.05±0.72 0.37±0.47 <0.001
Late lumen loss, mm 0.43±0.62 0.99±0.55 <0.001
TVA, mm2 329.79±215.21 172.46±157.08 <0.001
TVAL, % 11.94±33.50 54.18±34.03 <0.001

Abbreviations: CD-TLR, clinically-driven target lesion revascularization; DCB, drug-coated balloon; TVA, transverse-view vessel area; TVAL,
transverse-view vessel area loss.
a
Continuous data are presented as the mean ± standard deviation; categorical data are given as the number (percentage).
b
Calculated in the angiographic follow-up cohort.
c
Calculated per patient (for patients with >1 lesion, if any lesion was occluded during the 6-month follow-up, the patient was included in the occlusion
group).
d
Calculated per patient (for patients with >1 lesion, if any lesion was revascularized during the 6-month follow-up, the patient was included in the
CD-TLR group).

control patients vs 1 patient (1.6%) in the DCB group
(p=0.33) who underwent repeat angioplasty within 30
days. The proportion of patients with MAEs at 12 months
was 11.9% in the DCB group vs 28.6% in the control group
(p=0.03; Table 4). One patient (1.7%) died of pneumonia
in the DCB group, and 2 patients (3.6%) died of cardiac
complications in the control group within 12 months. One
patient in each group experienced a major amputation of
the target extremity within 6 months (both patients were
Rutherford category 6 at baseline). Kaplan-Meier analysis
(Figure 2) revealed that the freedom from CD-TLR at the
12-month follow-up was 91.8% (95% CI 81.9% to 97.3%)
in the DCB group and 78.0% (95% CI 65.3% to 87.7%)
in the control group (p=0.028). Complete foot healing
(Table 4) was achieved in 26 of 31 patients with wounds
(83.9%) in the DCB group vs 24 of 32 patients (75.0%)
with wounds in the control group (p=0.39). The healing
time did not differ significantly (p=0.18).
Discussion
Treatment of CLTI patients represents a challenge for endo-
vascular specialists due to the anatomical pattern of infra­
popliteal atherosclerotic disease, with long and multivessel
occlusions. Restenosis remains the Achilles’ heel of plain
balloon angioplasty and can be as high as 70% in the tibial
arteries.6–10 The AcoArt II study was designed to prove the
efficacy and safety of DCBs vs conventional balloons in
BTK interventions. The DCBs showed similar safety to
uncoated balloons in terms of all-cause mortality and
major amputation rate at 1-, 6-, and 12-month follow-up.
Compared with previous studies,6–10 our data show superior
6 Journal of Endovascular Therapy 00(0)

Table 4.  Safety and Clinical Outcomes at 12 Months.a

DCB (n=61) Control (n=59) p

Safety endpoint 7/59 (11.9) 16/56 (28.6) 0.03
 Death 1/59 (1.7)b 2/56 (3.6) 0.53
 CD-TLRc 5/59 (8.5) 13/56 (23.2) 0.03
  Major amputation 1/59 (1.7) 1/56 (1.8) 0.97
CD-TLRc 5/59 (8.5) 13/56 (23.2) 0.03
Complete healing 26/31 (83.9) 24/32 (75.0) 0.39
Healing time, d 103.35±86.21 141.29±111.87 0.18

Abbreviations: CD-TLR, clinically-driven target lesion revascularization; DCB, drug-coated balloon.

a
Continuous data are presented as the mean ± standard deviation; categorical data are given as the number (percentage).
b
Death was due to pneumonia at 247 days after the procedure.
c
Calculated per patient (for patients with >1 lesion, if any lesion was revascularized during the 6-month follow-up, the patient was included in the
CD-TLR group).

reported previously,8,9 in which no differences in terms of

LLL or binary restenosis were observed between DCBs
and uncoated balloons.
The efficacy of a DCB depends on the capability to
release the paclitaxel particles into the vessel wall and to
provide drug retention for a long antiproliferative effect.
Both of these aspects depend on the carrier and coating
technology used, which makes each DCB different from
another. The increased patency provided by the DCBs in
this randomized trial translated into a better clinical out-
come with a significant reduction in the need for TLR and a
higher rate of complete wound healing. Longer follow-up
data are being collected to determine if the benefit shown at
12 months can be maintained long term.

Figure 2.  Freedom from clinically-driven target lesion
revascularization (CD-TLR) at 12 months.
safety results, with relatively low mortality (1.7% in DCBs
vs 3.6% in controls) and major amputation rates (1.7% in
DCBs vs 1.8% in controls) at 12 months. This observation
is probably related to the presence of wound care teams and
surveillance programs in all 11 centers participating in the
trial. Moreover, vessel patency is necessary but not suffi-
cient for ulcer healing, and as a consequence, every CLTI
center should provide a combination of patency and healing
surveillance to improve limb preservation. The presence or
absence of a wound care program may explain the large dif-
ference in the proportion of major amputations reported in a
recent meta-analysis on trials focusing on DCBs for BTK
interventions.11
The efficacy of DCBs in controlling intimal hyperplasia
is shown by reductions in LLL, vessel occlusion, and
TVAL relative to those of conventional angioplasty at
6 months. These results compare favorably with those
Limitations
In the study protocol, follow-up was not required by the
physician who treated the patient. No specific measures
were taken to blind the person who performed the repeat
angiography or who made the decision about CD-TLR,
whereas quantitative evaluation of the angiograms was per-
formed by a core laboratory blinded to the type of treatment
provided.
Conclusion
This study demonstrated that the Litos/Tulip DCBs are
safe and effective in treating infrapopliteal lesions, with
improved angiographic and clinical outcomes vs plain
balloon angioplasty. The DCBs demonstrated significantly
better primary patency with fewer CD-TLRs than conven-
tional angioplasty. The safety of the DCBs was noninferior
to that of the uncoated balloons after 1 year of follow-up.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
Jia et al 7
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: The
AcoArt II–BTK study was sponsored by Acotec Scientific.
ORCID iD
Xin Jia https://orcid.org/0000-0003-0012-847X
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