PMID- 37844137
OWN - NLM
STAT- MEDLINE
DCOM- 20240102
LR  - 20240429
IS  - 1477-0377 (Electronic)
IS  - 1358-863X (Print)
IS  - 1358-863X (Linking)
VI  - 28
IP  - 6
DP  - 2023 Dec
TI  - Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol 
      stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.
PG  - 571-580
LID - 10.1177/1358863X231199489 [doi]
AB  - BACKGROUND: Effective and durable options for infrapopliteal artery 
      revascularization for patients with chronic limb-threatening ischemia (CLTI) are 
      limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial 
      of patients with CLTI and infrapopliteal artery lesions with total lesion length 
      ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment 
      with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or 
      percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary 
      effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated 
      duplex ultrasound-based flow at 12 months in the absence of clinically driven 
      target lesion revascularization or surgical bypass of the target lesion). The 
      primary safety endpoint was the 12-month major adverse event (MAE)-free rate; 
      MAEs were defined as a composite of above-ankle index limb amputation, major 
      reintervention, and 30-day mortality. The endpoints were prespecified for 
      superiority (effectiveness) and noninferiority (safety) at a one-sided 
      significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and 
      randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length 
      was 68.1 +/- 35.2 mm for the DES group and 68.7 +/- 49.2 mm for the PTA group, and 
      31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary 
      patency rates were 68.0% for the DES group and 76.0% for the PTA group 
      (P(superiority) = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively 
      (P(noninferiority) = 0.0433). CONCLUSION: The SAVAL trial did not show benefit 
      related to effectiveness and safety with the nitinol DES compared with PTA in 
      infrapopliteal artery lesions up to 140 mm in length. Continued innovation to 
      provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: 
      NCT03551496).
FAU - van Overhagen, Hans
AU  - van Overhagen H
AD  - Haga Teaching Hospital, Den Haag, South Holland, The Netherlands.
FAU - Nakamura, Masato
AU  - Nakamura M
AD  - Toho University Ohashi Medical Center, Meguro, Tokyo, Japan.
FAU - Geraghty, Patrick J
AU  - Geraghty PJ
AD  - Washington University School of Medicine, St Louis, MO, USA.
FAU - Rao, Sid
AU  - Rao S
AD  - Vascular Solutions of North Carolina, Cary, NC, USA.
FAU - Arroyo, Max
AU  - Arroyo M
AD  - St Bernard's Heart and Vascular, Jonesboro, AR, USA.
FAU - Soga, Yoshimitsu
AU  - Soga Y
AD  - Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.
FAU - Iida, Osamu
AU  - Iida O
AUID- ORCID: 0000-0001-6829-7304
AD  - Kansai Rosai Hospital, Hyogo, Amagasaki, Japan.
FAU - Armstrong, Ehrin
AU  - Armstrong E
AUID- ORCID: 0000-0002-5682-8363
AD  - Rocky Mountain Regional VA Medical Center, Aurora, CO, USA.
AD  - Adventist Heart and Vascular Institute, Adventist Health, St Helena, CA, USA 
      (current).
FAU - Nakama, Tatsuya
AU  - Nakama T
AD  - Tokyo Bay Medical Center, Urayasu, Japan.
FAU - Fujihara, Masahiko
AU  - Fujihara M
AD  - Kishiwada Tokushukai Hospital, Osaka, Osaka Prefecture, Japan.
FAU - Ansari, Mohammad M
AU  - Ansari MM
AD  - Texas Tech University Health Sciences Center, Lubbock, TX, USA.
FAU - Mathews, Santhosh J
AU  - Mathews SJ
AD  - Bradenton Cardiology Center, Manatee Memorial Hospital, Bradenton, FL, USA.
FAU - Goueffic, Yann
AU  - Goueffic Y
AD  - Groupe Hospitalier Paris Saint Joseph, Paris, Ile-de-France, France.
FAU - Jaff, Michael R
AU  - Jaff MR
AD  - Boston Scientific, Marlborough, MA, USA.
FAU - Weinberg, Ido
AU  - Weinberg I
AD  - VasCore - The Vascular Imaging Core Laboratory, Boston, MA, USA.
FAU - Pinto, Duane S
AU  - Pinto DS
AD  - Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
FAU - Ohura, Norihiko
AU  - Ohura N
AD  - Kyorin University School of Medicine, Mitaka, Tokyo, Japan.
FAU - Couch, Kara
AU  - Couch K
AD  - George Washington University Hospital, Washington, DC, USA.
FAU - Mustapha, Jihad A
AU  - Mustapha JA
AUID- ORCID: 0000-0002-6351-8080
AD  - Michigan State University College of Human Medicine, East Lansing, MI, USA.
AD  - Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids, 
      MI, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03551496
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20231016
PL  - England
TA  - Vasc Med
JT  - Vascular medicine (London, England)
JID - 9610930
RN  - 2EWL73IJ7F (nitinol)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Humans
MH  - *Angioplasty, Balloon/adverse effects
MH  - *Drug-Eluting Stents/adverse effects
MH  - Ischemia/diagnostic imaging/therapy
MH  - Paclitaxel/adverse effects
MH  - *Peripheral Arterial Disease/diagnostic imaging/therapy
MH  - Popliteal Artery/diagnostic imaging
MH  - Prospective Studies
MH  - Stents
MH  - Treatment Outcome
MH  - Vascular Patency
PMC - PMC10693734
OTO - NOTNLM
OT  - chronic limb-threatening ischemia (CLTI)
OT  - endovascular therapy
OT  - peripheral artery disease (PAD)
OT  - stent
COIS- Declaration of conflicting interestsHans van Overhagen, MD, PhD, serves as a 
      consultant for Boston Scientific and Cordis. Masato Nakamura, MD, PhD, serves as 
      a consultant for Terumo Co. and Boston Scientific; has received honoraria from 
      Boston Scientific and Terumo Co. Patrick J Geraghty, MD, holds stock or stock 
      options in MedAlliance SA, Aveera, Protexa, and Pulse Therapeutics. Sid Rao, MD, 
      serves as a consultant for Cardiovascular Systems, Inc. and Philips. Max Arroyo, 
      MD, has no conflicts of interest to declare. Yoshimitsu Soga, MD, serves as an 
      advisor to Boston Scientific. Osamu Iida, MD, serves as a consultant for Boston 
      Scientific. Ehrin Armstrong, MD, serves as a consultant for Abbott Vascular, 
      Boston Scientific, Gore, Medtronic, Philips, and Shockwave Medical. Tatsuya 
      Nakama, MD, serves as a consultant for Boston Scientific, BD, Cook Medical, 
      Cordis, Kaneka, NIPRO, and OrbusNeichi. Masahiko Fujihara, MD, serves as a 
      consultant for Boston Scientific. Mohammad M Ansari, MD, serves as an advisory 
      board member for Boston Scientific, Medtronic, and Cordis; a steering committee 
      member for Philips; a consultant for Boston Scientific, Terumo, Edwards, Gore, 
      Abbott, Bard, and Medtronic; has research trials with Boston Scientific, Terumo, 
      Gore, Abbott, and Reflow Medical. Santhosh J Mathews, MD, MS, serves as a 
      consultant and advisory board member for Philips, Boston Scientific, Abbott 
      Vascular, and Reflow Medical; a consultant for Penumbra, Cordis, and Shockwave. 
      Yann Goueffic, MD, PhD, has received research funding from Abbott, Boston 
      Scientific, General Electric, Veryan, WL Gore, and personal fees and grants from 
      Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, 
      Penumbra, Terumo, Veryan, and WL Gore. Michael R Jaff, DO, is an employee of 
      Boston Scientific, is a board member of Access Vascular; serves as a consultant 
      for Gilde Healthcare; has an equity investment in R3 Vascular and EFemoral. Ido 
      Weinberg, MD, serves as a consultant to Magneto Thrombectomy Solutions and 
      Penumbra, Inc.; is an employee of VasCore. Duane S Pinto, MD, MPH, serves as a 
      consultant to Abbott Vascular, Abiomed, Biotronik, Boston Scientific, Magenta 
      Medical, Medtronic, NuPulseCV, Terumo; has employment with JenaValve Technology. 
      Norihiko Ohura, MD, serves as a consultant for Boston Scientific. Kara Couch, MS, 
      CRNP, CWCN-AP, FAAWC, serves as a consultant for Boston Scientific and vTail; is 
      on the speaker's bureau for 3M, Urgo Medical North America, and Organogenesis, 
      Inc. Jihad A Mustapha, MD, serves as a consultant to Angiodynamics, BD Bard, 
      Cardiovascular Systems, Inc., Medtronic, Philips; a consultant and researcher for 
      Avinger, Boston Scientific, Endologix, and Terumo; is Chief Medical Officer for 
      Micromedical; has equity ownership and is a researcher and board member of 
      CardioFlow; has equity ownership of Iatri; is a researcher and has stock options 
      in Reflow Medical.
EDAT- 2023/10/16 18:42
MHDA- 2023/12/04 12:43
PMCR- 2023/12/03
CRDT- 2023/10/16 13:53
PHST- 2023/12/04 12:43 [medline]
PHST- 2023/10/16 18:42 [pubmed]
PHST- 2023/10/16 13:53 [entrez]
PHST- 2023/12/03 00:00 [pmc-release]
AID - 10.1177_1358863X231199489 [pii]
AID - 10.1177/1358863X231199489 [doi]
PST - ppublish
SO  - Vasc Med. 2023 Dec;28(6):571-580. doi: 10.1177/1358863X231199489. Epub 2023 Oct 
      16.