PMID- 34152229
OWN - NLM
STAT- MEDLINE
DCOM- 20210920
LR  - 20220531
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 28
IP  - 5
DP  - 2021 Oct
TI  - Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound 
      Healing.
PG  - 778-787
LID - 10.1177/15266028211025023 [doi]
AB  - PURPOSE: Clinical trials have demonstrated sustained benefits of drug-coated 
      balloon (DCB) angioplasty compared with noncoated balloon angioplasty in 
      symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) 
      artery disease. However, there is still controversy whether particulate 
      embolization caused by crystalline paclitaxel, the so-called "downstream effect," 
      is adversely associated with clinical outcomes after use of FP DCB among chronic 
      limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of 
      Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study 
      investigated wound healing following DCB therapy vs non-DCB therapy for 
      real-world CLTI patients presenting with FP lesions. MATERIALS AND METHODS: This 
      multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76+/-10 
      years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP 
      lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 
      patients) between April 2014 and March 2019. The primary outcome measure was 
      1-year wound healing, while the secondary outcome measure was 1-year primary 
      patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage 
      and overall survival were also analyzed by using propensity score matching 
      analysis. RESULTS: The propensity score matching extracted 111 pairs (as many 
      patients in the DCB group and 629 patients in the non-DCB group). The 1-year 
      cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the 
      DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant 
      intergroup difference (p=0.93). The DCB group had a higher rate of primary 
      patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, 
      whereas there was no significant intergroup difference in limb salvage (p=0.21) 
      or overall survival (p=0.93). CONCLUSION: The current analysis of data from the 
      RADISH study demonstrated that DCB therapy did not lead to delayed wound healing 
      and reduced restenosis rate in CLTI patients presenting FP lesions. From this 
      results, DCB therapy would be a reasonable treatment option for CLTI patients.
FAU - Hata, Yosuke
AU  - Hata Y
AUID- ORCID: 0000-0001-5482-3502
AD  - Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
FAU - Iida, Osamu
AU  - Iida O
AUID- ORCID: 0000-0001-6829-7304
AD  - Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
FAU - Ito, Nobuhiro
AU  - Ito N
AD  - Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.
FAU - Soga, Yoshimitsu
AU  - Soga Y
AUID- ORCID: 0000-0003-1931-5769
AD  - Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.
FAU - Fukunaga, Masashi
AU  - Fukunaga M
AD  - Department of Cardiology, Morinomiya Hospital, Osaka, Japan.
FAU - Kawasaki, Daizo
AU  - Kawasaki D
AUID- ORCID: 0000-0002-4413-6773
AD  - Department of Cardiology, Morinomiya Hospital, Osaka, Japan.
FAU - Fujihara, Masahiko
AU  - Fujihara M
AUID- ORCID: 0000-0002-7001-9220
AD  - Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Osaka, Japan.
FAU - Kozuki, Amane
AU  - Kozuki A
AUID- ORCID: 0000-0002-7723-3625
AD  - Department of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
FAU - Takahara, Mitsuyoshi
AU  - Takahara M
AD  - Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 
      Osaka, Japan.
AD  - Department of Diabetes Care Medicine, Osaka University Graduate School of 
      Medicine, Osaka, Japan.
FAU - Mano, Toshiaki
AU  - Mano T
AD  - Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210621
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  - Aged, 80 and over
MH  - *Angioplasty, Balloon/adverse effects/methods
MH  - Coated Materials, Biocompatible
MH  - Female
MH  - Femoral Artery
MH  - Humans
MH  - Ischemia/diagnostic imaging/therapy
MH  - Male
MH  - *Peripheral Arterial Disease/diagnostic imaging/therapy
MH  - *Pharmaceutical Preparations
MH  - Popliteal Artery
MH  - Retrospective Studies
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vascular Patency
MH  - Wound Healing
OTO - NOTNLM
OT  - chronic limb-threatening ischemia
OT  - drug-coated balloon
OT  - endovascular therapy
OT  - femoropopliteal artery disease
OT  - wound healing
EDAT- 2021/06/22 06:00
MHDA- 2021/09/21 06:00
CRDT- 2021/06/21 12:13
PHST- 2021/06/22 06:00 [pubmed]
PHST- 2021/09/21 06:00 [medline]
PHST- 2021/06/21 12:13 [entrez]
AID - 10.1177/15266028211025023 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2021 Oct;28(5):778-787. doi: 10.1177/15266028211025023. Epub 
      2021 Jun 21.