PMID- 38544413
OWN - NLM
STAT- Publisher
LR  - 20240410
IS  - 1477-0377 (Electronic)
IS  - 1358-863X (Linking)
DP  - 2024 Mar 27
TI  - Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of 
      complex femoropopliteal lesions from a Japanese postmarket surveillance study.
PG  - 1358863X241233528
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
DEP - 20240327
PL  - England
TA  - Vasc Med
JT  - Vascular medicine (London, England)
JID - 9610930
SB  - IM
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: W. L. Gore & Associates, Inc. provided funding for 
      the medical writer, unaffiliated with Gore, to assist with preparation of the 
      manuscript. W. L. Gore & Associates, Inc. participated in the study design and 
      collection, analysis, and assisted with interpretation of the data but was not 
      involved in constructing the manuscript contents and the decision to submit the 
      manuscript for publication.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- 2024/03/28 06:44
CRDT- 2024/03/28 02:43
PHST- 2024/03/28 06:44 [pubmed]
PHST- 2024/03/28 06:44 [medline]
PHST- 2024/03/28 02:43 [entrez]
AID - 10.1177/1358863X241233528 [doi]
PST - aheadofprint
SO  - Vasc Med. 2024 Mar 27:1358863X241233528. doi: 10.1177/1358863X241233528.