PMID- 38544413
OWN - NLM
STAT- MEDLINE
DCOM- 20240813
LR  - 20250324
IS  - 1477-0377 (Electronic)
IS  - 1358-863X (Print)
IS  - 1358-863X (Linking)
VI  - 29
IP  - 4
DP  - 2024 Aug
TI  - Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of 
      complex femoropopliteal lesions from a Japanese postmarket surveillance study.
PG  - 416-423
LID - 10.1177/1358863X241233528 [doi]
AB  - Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for 
      treatment of symptomatic patients with peripheral artery disease (PAD) and 
      complex femoropopliteal (FP) lesions was assessed in a real-world Japanese 
      practice setting. Methods: A prospective, multicenter, postmarket surveillance 
      study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients 
      with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 
      to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years 
      were primary patency (PP), primary-assisted patency (PAP), secondary patency 
      (SP), freedom from target lesion revascularization (fTLR), occurrence of device- 
      or procedure-related serious adverse events (SAEs), and stent fractures. Results: 
      A total of 321 patients were enrolled and were a mean age of 73.9 +/- 8.7 years; 
      77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean 
      lesion length was 23.6 +/- 6.6 cm and the frequency with TASC II C/D lesions and 
      chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier 
      estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, 
      respectively. The mean ankle-brachial index was 0.92 +/- 0.15 and the mean 
      improvement in Rutherford class was 2.3 +/- 1.4, which was maintained through 5 
      years. The rate of cumulative device- or procedure-related SAEs through 5 years 
      was 19.9% with only 9.3% of those occurring after the first year. No stent 
      fractures were observed through 5 years by x-ray evaluation. Conclusion: The 
      5-year safety and efficacy outcomes of the endoprosthesis were clinically 
      acceptable for treating complex FP lesions in a real-world cohort of Japanese 
      patients with PAD. (ClinicalTrials.gov Identifier: NCT04706273).
FAU - Iida, Osamu
AU  - Iida O
AUID- ORCID: 0000-0001-6829-7304
AD  - Osaka Police Hospital Cardiovascular Division, Osaka, Japan.
FAU - Ohki, Takao
AU  - Ohki T
AD  - Department of Surgery, Jikei University Hospital, Tokyo, Japan.
FAU - Soga, Yoshimitsu
AU  - Soga Y
AUID- ORCID: 0000-0003-1931-5769
AD  - Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
FAU - Suematsu, Nobuhiro
AU  - Suematsu N
AD  - Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
FAU - Nakama, Tatsuya
AU  - Nakama T
AD  - Department of Cardiology, Tokyo Bay Medical Center, Chiba, Japan.
FAU - Yamaoka, Terutoshi
AU  - Yamaoka T
AD  - Department of Vascular Surgery, Matsuyama Red Cross Hospital, Ehime, Japan.
FAU - Tobita, Kazuki
AU  - Tobita K
AUID- ORCID: 0000-0002-1913-6894
AD  - Department of Cardiovascular Medicine, Shonan Kamakura General Hospital, 
      Kanagawa, Japan.
FAU - Ichihashi, Shigeo
AU  - Ichihashi S
AUID- ORCID: 0000-0003-1809-4079
AD  - Department of Radiology and IVR Center, Nara Medical University, Nara, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT04706273
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20240327
PL  - England
TA  - Vasc Med
JT  - Vascular medicine (London, England)
JID - 9610930
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Blood Vessel Prosthesis
MH  - Blood Vessel Prosthesis Implantation/instrumentation/adverse effects
MH  - East Asian People
MH  - Endovascular Procedures/instrumentation/adverse effects
MH  - Femoral Artery/physiopathology/diagnostic imaging/surgery
MH  - Japan
MH  - *Peripheral Arterial Disease/physiopathology/diagnostic imaging/therapy/surgery
MH  - Popliteal Artery/physiopathology/diagnostic imaging/surgery
MH  - *Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - *Prosthesis Design
MH  - Risk Factors
MH  - *Stents
MH  - Time Factors
MH  - Treatment Outcome
MH  - *Vascular Patency
PMC - PMC11323428
OTO - NOTNLM
OT  - acute limb ischemia (ALI)
OT  - ankle-brachial index (ABI)
OT  - critical limb-threatening ischemia (CLTI)
OT  - endovascular therapy
OT  - peripheral artery disease (PAD)
OT  - stent
COIS- Declaration of conflicting interestsThe authors declared the following potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: Osamu Iida - advisory boards: Boston Scientific, 
      Cordis; consultant: Boston Scientific, Otsuka Medical; honorarium: Boston 
      Scientific Japan, Becton Dickinson, Cordis, W. L. Gore, Medtronic Japan, Terumo 
      Co., Ltd. Takao Ohki - consultant: W. L. Gore. Yoshimitsu Soga - honorarium: 
      Boston Scientific, Cordis, Kaneka Medics, Medtronic Japan, Terumo Co., Ltd. 
      Tatsuya Nakama - advisory boards: Asahi Intecc; consultant: Becton Dickinson, 
      Boston Scientific, COOK Medical, Century Medical Inc., Cordis, NIPRO, 
      OrbusNeichi; honorarium: Abbott Vascular, KANEKA, Medtronic, Terumo Co., Ltd. 
      Terutoshi Yamoaka - consultant: JAPAN LIFELINE; honorarium: W. L. Gore, Boston 
      Scientific Japan, Kaneka Medix. Kazuki Tobita - honorarium: W. L. Gore, Boston 
      Scientific, Medtronic, Terumo, Kaneka Medics, Becton Dickinson. The other authors 
      have no conflicts of interest to declare.
EDAT- 2024/03/28 06:44
MHDA- 2024/08/13 06:42
PMCR- 2024/08/14
CRDT- 2024/03/28 02:43
PHST- 2024/08/13 06:42 [medline]
PHST- 2024/03/28 06:44 [pubmed]
PHST- 2024/03/28 02:43 [entrez]
PHST- 2024/08/14 00:00 [pmc-release]
AID - 10.1177_1358863X241233528 [pii]
AID - 10.1177/1358863X241233528 [doi]
PST - ppublish
SO  - Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 
      27.