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Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries
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 le...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693734/ https://www.ncbi.nlm.nih.gov/pubmed/37844137 http://dx.doi.org/10.1177/1358863X231199489 |
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author | van Overhagen, Hans Nakamura, Masato Geraghty, Patrick J Rao, Sid Arroyo, Max Soga, Yoshimitsu Iida, Osamu Armstrong, Ehrin Nakama, Tatsuya Fujihara, Masahiko Ansari, Mohammad M Mathews, Santhosh J Gouëffic, Yann Jaff, Michael R Weinberg, Ido Pinto, Duane S Ohura, Norihiko Couch, Kara Mustapha, Jihad A |
author_facet | van Overhagen, Hans Nakamura, Masato Geraghty, Patrick J Rao, Sid Arroyo, Max Soga, Yoshimitsu Iida, Osamu Armstrong, Ehrin Nakama, Tatsuya Fujihara, Masahiko Ansari, Mohammad M Mathews, Santhosh J Gouëffic, Yann Jaff, Michael R Weinberg, Ido Pinto, Duane S Ohura, Norihiko Couch, Kara Mustapha, Jihad A |
author_sort | van Overhagen, Hans |
collection | PubMed |
description | 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) |
format | Online Article Text |
id | pubmed-10693734 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-106937342023-12-04 Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries van Overhagen, Hans Nakamura, Masato Geraghty, Patrick J Rao, Sid Arroyo, Max Soga, Yoshimitsu Iida, Osamu Armstrong, Ehrin Nakama, Tatsuya Fujihara, Masahiko Ansari, Mohammad M Mathews, Santhosh J Gouëffic, Yann Jaff, Michael R Weinberg, Ido Pinto, Duane S Ohura, Norihiko Couch, Kara Mustapha, Jihad A Vasc Med Original Research Articles 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) SAGE Publications 2023-10-16 2023-12 /pmc/articles/PMC10693734/ /pubmed/37844137 http://dx.doi.org/10.1177/1358863X231199489 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Research Articles van Overhagen, Hans Nakamura, Masato Geraghty, Patrick J Rao, Sid Arroyo, Max Soga, Yoshimitsu Iida, Osamu Armstrong, Ehrin Nakama, Tatsuya Fujihara, Masahiko Ansari, Mohammad M Mathews, Santhosh J Gouëffic, Yann Jaff, Michael R Weinberg, Ido Pinto, Duane S Ohura, Norihiko Couch, Kara Mustapha, Jihad A Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title | Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title_full | Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title_fullStr | Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title_full_unstemmed | Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title_short | Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
title_sort | primary results of the saval randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries |
topic | Original Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693734/ https://www.ncbi.nlm.nih.gov/pubmed/37844137 http://dx.doi.org/10.1177/1358863X231199489 |
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