PMID- 35709851
OWN - NLM
STAT- MEDLINE
DCOM- 20220928
LR  - 20221025
IS  - 1097-6809 (Electronic)
IS  - 0741-5214 (Linking)
VI  - 76
IP  - 4
DP  - 2022 Oct
TI  - Use of paclitaxel-coated balloons in clinical setting is not associated with 
      increased mortality compared with plain balloon angioplasty in femoropopliteal 
      lesions.
PG  - 979-986
LID - S0741-5214(22)01647-0 [pii]
LID - 10.1016/j.jvs.2022.06.002 [doi]
AB  - OBJECTIVE: To investigate mortality and causes of death associated with the use 
      of paclitaxel-coated balloon (PCB) compared with plain balloon (PB) angioplasty 
      in the treatment of femoropopliteal artery lesions in real-world clinical 
      setting. METHODS: This retrospective, single-center study included patients who 
      underwent percutaneous femoropopliteal artery angioplasty without stenting 
      between years 2014 and 2020. Patients were stratified into PCB and PB groups 
      according to the index procedure. Those who had undergone any prior or subsequent 
      intervention using drug-eluting technology were excluded from the PB group. 
      Long-term survival was estimated up to 5 years using the Kaplan-Meier method, and 
      risk factors for all-cause mortality were assessed in a multivariable analysis. 
      Causes of death were retrieved from a national registry. RESULTS: The study 
      included 139 patients treated with PB and 190 with PCB. Patients treated with PCB 
      had a higher prevalence of chronic pulmonary disease (27% vs 17%; P = .02) and 
      were less often on anticoagulant therapy (34% vs 48%; P = .01) compared with 
      patients in the PB group. Those treated with PB were more likely to have chronic 
      limb-threatening ischemia (CLTI; 82% vs 72%; P = .04). Ipsilateral perioperative 
      amputation rate was significantly higher in the PB group (7% vs 1%; P = .01). 
      There were no major differences in other 30-day outcomes between the groups and 
      no differences in the rates of reinterventions and ipsilateral amputations during 
      a mean follow-up time of 2.7 +/- 1.9 years. Survival at 1 year in the PCB group was 
      83% +/- 3% compared with 73% +/- 4% in the PB group (P = .0001). The 5-year survival 
      estimates were 56% +/- 5% and 37% +/- 5%, respectively. PCB use was independently 
      associated with decreased risk of mortality (hazard ratio [HR], 0.70; 95% 
      confidence interval [CI], 0.50-0.97). Independent risk factors for increased 
      mortality were age (HR, 1.04 per year; 95% CI, 1.02-1.06), cardiac insufficiency 
      (HR, 1.60; 95% CI, 1.12-2.27), chronic renal insufficiency (HR, 2.04; 95% CI, 
      1.47-2.85), anticoagulation therapy (HR, 1.65, 95% CI, 1.16-2.34), and CLTI (HR, 
      2.85; 95% CI, 1.51-5.39). In the PCB group, 63% of deaths were due to 
      cardiovascular causes compared with 42% in the PB group (P < .01). CONCLUSIONS: 
      The use of PCB is safe, and there is no concern of increased mortality after the 
      procedure based on the 5-year survival estimates.
CI  - Copyright (c) 2022 Society for Vascular Surgery. Published by Elsevier Inc. All 
      rights reserved.
FAU - Kalbus, Viljar
AU  - Kalbus V
AD  - Heart Center, Kuopio University Hospital, Kuopio, Finland.
FAU - Karkkainen, Jussi M
AU  - Karkkainen JM
AD  - Heart Center, Kuopio University Hospital, Kuopio, Finland. Electronic address: 
      jkarkkai@gmail.com.
FAU - Wallin, Wilhelmiina
AU  - Wallin W
AD  - Faculty of Medicine, University of Eastern Finland, Kuopio, Finland.
FAU - Kettunen, Moona
AU  - Kettunen M
AD  - Faculty of Medicine, University of Eastern Finland, Kuopio, Finland.
FAU - Koivusalo, Kalle
AU  - Koivusalo K
AD  - Faculty of Medicine, University of Eastern Finland, Kuopio, Finland.
FAU - Hartikainen, Juha
AU  - Hartikainen J
AD  - Heart Center, Kuopio University Hospital, Kuopio, Finland; Faculty of Medicine, 
      University of Eastern Finland, Kuopio, Finland.
FAU - Halonen, Jari
AU  - Halonen J
AD  - Heart Center, Kuopio University Hospital, Kuopio, Finland.
FAU - Saari, Petri
AU  - Saari P
AD  - Radiology Department, Kuopio University Hospital, Kuopio, Finland.
LA  - eng
PT  - Journal Article
DEP - 20220614
PL  - United States
TA  - J Vasc Surg
JT  - Journal of vascular surgery
JID - 8407742
RN  - 0 (Anticoagulants)
RN  - 0 (Cardiovascular Agents)
RN  - 0 (Coated Materials, Biocompatible)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - *Angioplasty, Balloon/adverse effects
MH  - Anticoagulants
MH  - *Cardiovascular Agents
MH  - Coated Materials, Biocompatible
MH  - Femoral Artery/diagnostic imaging
MH  - Humans
MH  - Paclitaxel/adverse effects
MH  - *Peripheral Arterial Disease/diagnostic imaging/therapy
MH  - Popliteal Artery/diagnostic imaging
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Drug-coated balloon
OT  - Endovascular intervention
OT  - Mortality
OT  - Paclitaxel
OT  - Peripheral artery disease
EDAT- 2022/06/17 06:00
MHDA- 2022/09/28 06:00
CRDT- 2022/06/16 19:22
PHST- 2022/03/11 00:00 [received]
PHST- 2022/05/20 00:00 [revised]
PHST- 2022/06/03 00:00 [accepted]
PHST- 2022/06/17 06:00 [pubmed]
PHST- 2022/09/28 06:00 [medline]
PHST- 2022/06/16 19:22 [entrez]
AID - S0741-5214(22)01647-0 [pii]
AID - 10.1016/j.jvs.2022.06.002 [doi]
PST - ppublish
SO  - J Vasc Surg. 2022 Oct;76(4):979-986. doi: 10.1016/j.jvs.2022.06.002. Epub 2022 
      Jun 14.