PMID- 33118432
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20210624
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 28
IP  - 2
DP  - 2021 Apr
TI  - Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment 
      of Infrapopliteal Artery Lesions (AcoArt II-BTK).
PG  - 215-221
LID - 10.1177/1526602820969681 [doi]
AB  - 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.
FAU - Jia, Xin
AU  - Jia X
AUID- ORCID: 0000-0003-0012-847X
AD  - Chinese PLA General Hospital, Beijing, China.
FAU - Zhuang, Baixi
AU  - Zhuang B
AD  - Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
FAU - Wang, Feng
AU  - Wang F
AD  - The First Affiliated Hospital of Dalian Medical University, Dalian, China.
FAU - Gu, Yongquan
AU  - Gu Y
AD  - Xuanwu Hospital, Capital Medical University, Beijing, China.
FAU - Zhang, Jiwei
AU  - Zhang J
AD  - Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
FAU - Lu, Xinwu
AU  - Lu X
AD  - The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, 
      Shanghai, China.
FAU - Dai, Xiangchen
AU  - Dai X
AD  - Tianjin Medical University General Hospital, Tianjin, China.
FAU - Liu, Zhaoyu
AU  - Liu Z
AD  - Shengjing Hospital of China Medical University, Shenyang, China.
FAU - Bi, Wei
AU  - Bi W
AD  - The Second Hospital of Hebei Medical University, Shijiazhuang, China.
FAU - Liu, Changwei
AU  - Liu C
AD  - Peking Union Medical College Hospital, Beijing, China.
FAU - Wang, Shenming
AU  - Wang S
AD  - The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
FAU - Liistro, Francesco
AU  - Liistro F
AD  - Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
FAU - Guo, Wei
AU  - Guo W
AD  - Chinese PLA General Hospital, Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02137577
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201029
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
RN  - 0 (Coated Materials, Biocompatible)
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Aged
MH  - *Angioplasty, Balloon/adverse effects
MH  - Coated Materials, Biocompatible
MH  - Femoral Artery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Peripheral Arterial Disease/diagnostic imaging/therapy
MH  - *Pharmaceutical Preparations
MH  - Popliteal Artery/diagnostic imaging
MH  - Prospective Studies
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vascular Patency
OTO - NOTNLM
OT  - anterior tibial artery
OT  - balloon angioplasty
OT  - below-the-knee artery
OT  - chronic limb-threatening ischemia
OT  - chronic total occlusion
OT  - drug-coated balloon
OT  - mortality
OT  - patency
OT  - randomized clinical trial
OT  - target lesion revascularization
EDAT- 2020/10/30 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/10/29 08:39
PHST- 2020/10/30 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/10/29 08:39 [entrez]
AID - 10.1177/1526602820969681 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2021 Apr;28(2):215-221. doi: 10.1177/1526602820969681. Epub 2020 
      Oct 29.