PMID- 32508220
OWN - NLM
STAT- MEDLINE
DCOM- 20201102
LR  - 20221207
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 27
IP  - 4
DP  - 2020 Aug
TI  - Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of 
      Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis.
PG  - 647-657
LID - 10.1177/1526602820931559 [doi]
AB  - Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for 
      the treatment of femoropopliteal or infrapopliteal lesions in patients with 
      chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic 
      literature search was conducted in PubMed, Scopus, and Cochrane Central up to 
      January 2020 to identify randomized trials and observational studies presenting 
      data on the effectiveness and safety of DCBs in the treatment of femoropopliteal 
      or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was 
      conducted to investigate primary patency and all-cause mortality at 12 months; 
      the results are reported as the odds ratios (ORs) and 95% confidence intervals 
      (CIs). Secondary outcomes were procedural success, bailout stenting, target 
      lesion revascularization (TLR), reocclusion, major amputation, wound healing, and 
      major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 
      prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal 
      (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion 
      lengths were 121+/-44 and 135+/-53 mm, respectively. The overall 12-month all-cause 
      mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% 
      to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% 
      (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal 
      lesions demonstrated no difference between DCB and balloon angioplasty in terms 
      of primary patency, TLR, major amputation, or mortality over 12 months. However, 
      patients with infrapopliteal lesions undergoing DCB angioplasty did have a 
      significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 
      0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal 
      lesions in patients with CLTI results in acceptable 12-month patency rates, 
      although comparative data have not shown a patency benefit for infrapopliteal 
      lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not 
      significantly different, but studies with longer-term outcomes are necessary to 
      determine any association between DCB use and mortality in patients with CLTI.
FAU - Giannopoulos, Stefanos
AU  - Giannopoulos S
AUID- ORCID: 0000-0002-1942-911X
AD  - Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of 
      Colorado, Denver, CO, USA.
FAU - Ghanian, Sheila
AU  - Ghanian S
AD  - Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of 
      Colorado, Denver, CO, USA.
FAU - Parikh, Sahil A
AU  - Parikh SA
AD  - Center for Interventional Vascular Therapy, Columbia University Irving Medical 
      Center, New York, NY, USA.
FAU - Secemsky, Eric A
AU  - Secemsky EA
AD  - Division of Cardiology, Beth Israel Medical Center, Boston, MA, USA.
FAU - Schneider, Peter A
AU  - Schneider PA
AD  - Division of Vascular and Endovascular Surgery, University of California at San 
      Francisco, CA, USA.
FAU - Armstrong, Ehrin J
AU  - Armstrong EJ
AUID- ORCID: 0000-0002-1381-4754
AD  - Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of 
      Colorado, Denver, CO, USA.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20200607
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)
SB  - IM
MH  - Aged
MH  - Amputation, Surgical
MH  - Angioplasty, Balloon/adverse effects/*instrumentation/mortality
MH  - Chronic Disease
MH  - *Coated Materials, Biocompatible
MH  - Female
MH  - *Femoral Artery/diagnostic imaging/physiopathology
MH  - Humans
MH  - Ischemia/diagnostic imaging/mortality/physiopathology/*therapy
MH  - Limb Salvage
MH  - Male
MH  - Peripheral Arterial Disease/diagnostic imaging/mortality/physiopathology/*therapy
MH  - *Popliteal Artery/diagnostic imaging/physiopathology
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vascular Patency
OTO - NOTNLM
OT  - balloon angioplasty
OT  - chronic limb-threatening ischemia
OT  - critical limb ischemia
OT  - drug-coated balloon
OT  - femoropopliteal segment
OT  - infrapopliteal arteries
OT  - mortality
OT  - primary patency
OT  - target lesion revascularization
EDAT- 2020/06/09 06:00
MHDA- 2020/11/03 06:00
CRDT- 2020/06/09 06:00
PHST- 2020/06/09 06:00 [pubmed]
PHST- 2020/11/03 06:00 [medline]
PHST- 2020/06/09 06:00 [entrez]
AID - 10.1177/1526602820931559 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2020 Aug;27(4):647-657. doi: 10.1177/1526602820931559. Epub 2020 
      Jun 7.