Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries

Hans van Overhagen, Masato Nakamura, Patrick J. Geraghty, Sid Rao, Max Arroyo, Yoshimitsu Soga, Osamu Iida, Ehrin Armstrong, Tatsuya Nakama, Masahiko Fujihara, Mohammad M. Ansari, Santhosh J. Mathews, Yann Gouëffic, Michael R. Jaff, Ido Weinberg, Duane S. Pinto, Norihiko Ohura, Kara Couch, Jihad A. Mustapha

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

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 (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 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

Original languageEnglish
Pages (from-to)571-580
Number of pages10
JournalVascular Medicine (United Kingdom)
Volume28
Issue number6
DOIs
StatePublished - Dec 2023

Keywords

  • chronic limb-threatening ischemia (CLTI)
  • endovascular therapy
  • peripheral artery disease (PAD)
  • stent

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