Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

doi:10.1056/NEJMoa2207899

Randomized Controlled Trial

. 2022 Dec 22;387(25):2305-2316.

doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

Alik Farber¹, Matthew T Menard¹, Michael S Conte¹, John A Kaufman¹, Richard J Powell¹, Niteesh K Choudhry¹, Taye H Hamza¹, Susan F Assmann¹, Mark A Creager¹, Mark J Cziraky¹, Michael D Dake¹, Michael R Jaff¹, Diane Reid¹, Flora S Siami¹, George Sopko¹, Christopher J White¹, Max van Over¹, Michael B Strong¹, Maria F Villarreal¹, Michelle McKean¹, Ezana Azene¹, Amir Azarbal¹, Andrew Barleben¹, David K Chew¹, Leonardo C Clavijo¹, Yvan Douville¹, Laura Findeiss¹, Nitin Garg¹, Warren Gasper¹, Kristina A Giles¹, Philip P Goodney¹, Beau M Hawkins¹, Christine R Herman¹, Jeffrey A Kalish¹, Matthew C Koopmann¹, Igor A Laskowski¹, Carlos Mena-Hurtado¹, Raghu Motaganahalli¹, Vincent L Rowe¹, Andres Schanzer¹, Peter A Schneider¹, Jeffrey J Siracuse¹, Maarit Venermo¹, Kenneth Rosenfield¹; BEST-CLI Investigators

Collaborators, Affiliations

Collaborators

BEST-CLI Investigators:
Mick Maurao, Satish Muluk, Michael Belkin, Sean Lyden, Mehdi Shishehbor, Danielle Bajakian, Philip Goodney, Yazan Duwayri, Nina Bowens, Timothy Nypaver, Dipankar Mukherjee, Daniel Obrand, Glenn LaMuraglia, Manju Kalra, Nelson Bernardo, Neal Barshes, Evan Lipsitz, J Stephen Jenkins, Warren Gasper, Christopher Owens, Frank Pomposelli, Kevin Rogers, Ageliki Vouyouka, Marc Passman, Constantino Pena, Venkatesh Ramaiah, John Hoch, Robert Bersin, Greg Hayes, Karen Ho, Aamir Shah, Ying Wei Lum, R Clement Darling 3rd, Oliver Aalami, Wei Zhou, Parag Patel, Abdulhameed Aziz, Brian Halloran, Enjae Jung, Erica Mitchell, Ulku Cenk Turba, Eric Choi, Jade Hiramoto, Ross Milner, Robert Crawford, Areck Ucuzian, Peter Henke, Rabih Chaer, Julie Lahiri Adams, Hugh Gelabert, Robert Safian, Carlos Mena-Hurtado, Daniel Ihnat, Vincent Rowe, Vikram Kashyap, Palma Shaw, Ethan Korngold, Thomas Lindsay, Gerrit Winkelaar, Matthew Mell, Bruce DuVal, Faisal Aziz, Amy Reed, Munier Nazzal, Andres Schanzer, Allen Hamdan, Matthew Smeds, Jeffrey Kalish, Jeffrey Slaiby, Mark Androes, Tod Hanover, Raghu Motaganahalli, Catherine Chang, Robert Hye, Jason Alexander, Gary Ansel, Todd Bohannon, Sapan Desai, Kim Hodgson, Douglas Hood, Randolph Pl Guzman, Kristina Giles, Samir Shah, Beau Hawkins, Thomas E Brothers, Ali Azizzadeh, Kristofer Charlton-Ouw, Sophia Khan, Benjamin S Brooke, Nii-Kabu Kabutey, Ravish Sachar, Hasan Dosluoglu, Scott Berman, John Blebea, Kevin Taubman, Yvan Douville, Mitchell W Cox, Joseph Davis, Michael Caps, Peter Schneider, Ahmed Abou-Zamzam, Robert Feldman, Gregory von Mering, Tze-Woei Tan, Chiranjiv S Virk, Wayne Zhang, Michael Bacharach, Craig Seidman, Mark Iafrati, Laura Findeiss, Charles Bailey, Murray Shames, John Lane, Donald Baril, Stephen Hass, Patrick Stone, Aditya Sharma, Margaret Tracci, Kent Mackenzie, Michael Stoner, Jean Starr, David McAllister, Niten Singh, Shirling Tsai, Scott Kinlay, Robyn Macsata, Richard Neville, John Rundback, Kate McGinigle, Raghu Vallabhaneni, Andrey Espinoza, Amir Azarbal, G Matthew Longo, Richard Kovach, Peter Soukas, Chris Metzger, Andre Artis, William Bachinsky, Ehrin Armstrong, Brack Hattler, Venita Chandra, Jonathan Schor, Christian Bianchi, Sharon Kiang, Eyal Ben-Arie, Michael Verta, Julia Wilkinson, Justin Hurie, David Kopriva, Robert Molnar, Linda Jun Chun, Ezana Azene, Clark Davis, Elizabeth Blazick, Steve Henao, Trent Proffitt, Christine Herman, Derek Nathan, Robert Chang, Leila Mureebe, Jerry Chen, Marcus Semel, Scott Fecteau, Manish Mehta, Sudhir Nagpal, Nicolas Shammas, Scott Kujath, Robert Beasley, Todd Vogel, Nasim Hedayati, James Brooks, Peter Nelson, Inkyong Parrack, Thomas Bernik, David Dexter, Kellie Brown, Joe Huang, Timothy Wu, Robert Hacker, Brandon Tyler Garland, Joseph Griffin, Igor Laskowski, Steven Pfau, Audra Duncan, Jeffrey Trachtenberg, Ian Gordon, Bernadette Aulivola, Mohamed Zayed, Maarit Venermo, Andrew Hill, Janaka Kesara Wickremesekera, Erika Ketteler, Stefano Michelagnoli, Ahmed Kayssi, Mohsen Bannazadeh, Nicholas Sikalas, Manar Khashram, Thodur Vasudevan, Justin Simmons, Nicholas Osborne, Charles Fox, Raghuveer Vallabhaneni

Affiliation

¹ From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F., M.F.V., J.A. Kalish, J.J.S.), the Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.) and the Department of Medicine (N.K.C.), Brigham and Women's Hospital, Harvard Medical School (M.R.J.), and the Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Boston, HealthCore, Watertown (T.H.H., S.F.A., M.J.C., M.O., M.M.), and the Division of Vascular Surgery, UMass Memorial Health, Worcester (A.S.) - all in Massachusetts; the Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco (M.S.C., W.G., P.A.S.), the Division of Vascular Surgery, UC San Diego Health, La Jolla (A.B.), Coastal Cardiology, French Hospital Medical Center, San Luis Obispo (L.C.C.), and the Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles (V.L.R.) - all in California; the Department of Interventional Radiology (J.A. Kaufman) and the Division of Vascular Surgery, School of Medicine (A.A.), Oregon Health and Science University, and the Operative Care Division, Portland VA Medical Center (M.C.K.) - all in Portland; the Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH (R.J.P., M.A.C., P.P.G.); the Department of Medical Imaging, University of Arizona Health Sciences, Tucson (M.D.D.), and the Division of Vascular Surgery, Peak Heart and Vascular, Glendale (N.G.) - both in Arizona; the National Heart, Lung, and Blood Institute, Bethesda, MD (D.R., G.S.); the Medical Device Innovation Consortium, National Evaluation System for Health Technology Coordinating Center, Arlington, VA (F.S.S.); the Department of Cardiovascular Diseases, Ochsner Clinical School, University of Queensland, Brisbane, Australia (C.J.W.); the Department of Interventional Radiology, Gundersen Health System, La Crosse, WI (E.A.); the Iowa Heart Center, Des Moines (D.K.C.); the Division of Vascular Surgery, Centre Hospitalier Universitaire de Quebec-Université Laval, Quebec City (Y.D.), and Dalhousie University, Division of Cardiac and Vascular Surgery, Department of Surgery, Nova Scotia Health Association, Halifax (C.R.H.) - both in Canada; the Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta (L.F.); the Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland (K.A.G.); the Cardiovascular Section, University of Oklahoma Health Sciences Center, Oklahoma City (B.M.H.); Westchester Medical Center and the Department of Surgery, Section of Vascular Surgery, New York Medical College - both in Valhalla, NY (I.A.L.); the Vascular Medicine Outcomes Program, Yale University, New Haven, CT (C.M.-H.); the Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis (R.M.); and the Department of Vascular Surgery, University of Helsinki, and Helsinki University Hospital - both in Helsinki (M.V.).

PMID: 36342173
DOI: 10.1056/NEJMoa2207899

Randomized Controlled Trial

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

Alik Farber et al. N Engl J Med. 2022.

. 2022 Dec 22;387(25):2305-2316.

doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7.

Authors

Collaborators

BEST-CLI Investigators:
Mick Maurao, Satish Muluk, Michael Belkin, Sean Lyden, Mehdi Shishehbor, Danielle Bajakian, Philip Goodney, Yazan Duwayri, Nina Bowens, Timothy Nypaver, Dipankar Mukherjee, Daniel Obrand, Glenn LaMuraglia, Manju Kalra, Nelson Bernardo, Neal Barshes, Evan Lipsitz, J Stephen Jenkins, Warren Gasper, Christopher Owens, Frank Pomposelli, Kevin Rogers, Ageliki Vouyouka, Marc Passman, Constantino Pena, Venkatesh Ramaiah, John Hoch, Robert Bersin, Greg Hayes, Karen Ho, Aamir Shah, Ying Wei Lum, R Clement Darling 3rd, Oliver Aalami, Wei Zhou, Parag Patel, Abdulhameed Aziz, Brian Halloran, Enjae Jung, Erica Mitchell, Ulku Cenk Turba, Eric Choi, Jade Hiramoto, Ross Milner, Robert Crawford, Areck Ucuzian, Peter Henke, Rabih Chaer, Julie Lahiri Adams, Hugh Gelabert, Robert Safian, Carlos Mena-Hurtado, Daniel Ihnat, Vincent Rowe, Vikram Kashyap, Palma Shaw, Ethan Korngold, Thomas Lindsay, Gerrit Winkelaar, Matthew Mell, Bruce DuVal, Faisal Aziz, Amy Reed, Munier Nazzal, Andres Schanzer, Allen Hamdan, Matthew Smeds, Jeffrey Kalish, Jeffrey Slaiby, Mark Androes, Tod Hanover, Raghu Motaganahalli, Catherine Chang, Robert Hye, Jason Alexander, Gary Ansel, Todd Bohannon, Sapan Desai, Kim Hodgson, Douglas Hood, Randolph Pl Guzman, Kristina Giles, Samir Shah, Beau Hawkins, Thomas E Brothers, Ali Azizzadeh, Kristofer Charlton-Ouw, Sophia Khan, Benjamin S Brooke, Nii-Kabu Kabutey, Ravish Sachar, Hasan Dosluoglu, Scott Berman, John Blebea, Kevin Taubman, Yvan Douville, Mitchell W Cox, Joseph Davis, Michael Caps, Peter Schneider, Ahmed Abou-Zamzam, Robert Feldman, Gregory von Mering, Tze-Woei Tan, Chiranjiv S Virk, Wayne Zhang, Michael Bacharach, Craig Seidman, Mark Iafrati, Laura Findeiss, Charles Bailey, Murray Shames, John Lane, Donald Baril, Stephen Hass, Patrick Stone, Aditya Sharma, Margaret Tracci, Kent Mackenzie, Michael Stoner, Jean Starr, David McAllister, Niten Singh, Shirling Tsai, Scott Kinlay, Robyn Macsata, Richard Neville, John Rundback, Kate McGinigle, Raghu Vallabhaneni, Andrey Espinoza, Amir Azarbal, G Matthew Longo, Richard Kovach, Peter Soukas, Chris Metzger, Andre Artis, William Bachinsky, Ehrin Armstrong, Brack Hattler, Venita Chandra, Jonathan Schor, Christian Bianchi, Sharon Kiang, Eyal Ben-Arie, Michael Verta, Julia Wilkinson, Justin Hurie, David Kopriva, Robert Molnar, Linda Jun Chun, Ezana Azene, Clark Davis, Elizabeth Blazick, Steve Henao, Trent Proffitt, Christine Herman, Derek Nathan, Robert Chang, Leila Mureebe, Jerry Chen, Marcus Semel, Scott Fecteau, Manish Mehta, Sudhir Nagpal, Nicolas Shammas, Scott Kujath, Robert Beasley, Todd Vogel, Nasim Hedayati, James Brooks, Peter Nelson, Inkyong Parrack, Thomas Bernik, David Dexter, Kellie Brown, Joe Huang, Timothy Wu, Robert Hacker, Brandon Tyler Garland, Joseph Griffin, Igor Laskowski, Steven Pfau, Audra Duncan, Jeffrey Trachtenberg, Ian Gordon, Bernadette Aulivola, Mohamed Zayed, Maarit Venermo, Andrew Hill, Janaka Kesara Wickremesekera, Erika Ketteler, Stefano Michelagnoli, Ahmed Kayssi, Mohsen Bannazadeh, Nicholas Sikalas, Manar Khashram, Thodur Vasudevan, Justin Simmons, Nicholas Osborne, Charles Fox, Raghuveer Vallabhaneni

Affiliation

¹ From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F., M.F.V., J.A. Kalish, J.J.S.), the Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.) and the Department of Medicine (N.K.C.), Brigham and Women's Hospital, Harvard Medical School (M.R.J.), and the Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Boston, HealthCore, Watertown (T.H.H., S.F.A., M.J.C., M.O., M.M.), and the Division of Vascular Surgery, UMass Memorial Health, Worcester (A.S.) - all in Massachusetts; the Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco (M.S.C., W.G., P.A.S.), the Division of Vascular Surgery, UC San Diego Health, La Jolla (A.B.), Coastal Cardiology, French Hospital Medical Center, San Luis Obispo (L.C.C.), and the Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles (V.L.R.) - all in California; the Department of Interventional Radiology (J.A. Kaufman) and the Division of Vascular Surgery, School of Medicine (A.A.), Oregon Health and Science University, and the Operative Care Division, Portland VA Medical Center (M.C.K.) - all in Portland; the Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH (R.J.P., M.A.C., P.P.G.); the Department of Medical Imaging, University of Arizona Health Sciences, Tucson (M.D.D.), and the Division of Vascular Surgery, Peak Heart and Vascular, Glendale (N.G.) - both in Arizona; the National Heart, Lung, and Blood Institute, Bethesda, MD (D.R., G.S.); the Medical Device Innovation Consortium, National Evaluation System for Health Technology Coordinating Center, Arlington, VA (F.S.S.); the Department of Cardiovascular Diseases, Ochsner Clinical School, University of Queensland, Brisbane, Australia (C.J.W.); the Department of Interventional Radiology, Gundersen Health System, La Crosse, WI (E.A.); the Iowa Heart Center, Des Moines (D.K.C.); the Division of Vascular Surgery, Centre Hospitalier Universitaire de Quebec-Université Laval, Quebec City (Y.D.), and Dalhousie University, Division of Cardiac and Vascular Surgery, Department of Surgery, Nova Scotia Health Association, Halifax (C.R.H.) - both in Canada; the Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta (L.F.); the Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland (K.A.G.); the Cardiovascular Section, University of Oklahoma Health Sciences Center, Oklahoma City (B.M.H.); Westchester Medical Center and the Department of Surgery, Section of Vascular Surgery, New York Medical College - both in Valhalla, NY (I.A.L.); the Vascular Medicine Outcomes Program, Yale University, New Haven, CT (C.M.-H.); the Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis (R.M.); and the Department of Vascular Surgery, University of Helsinki, and Helsinki University Hospital - both in Helsinki (M.V.).

PMID: 36342173
DOI: 10.1056/NEJMoa2207899

Abstract

Background: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes.

Methods: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause.

Results: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts.

Conclusions: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

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Surgery safer than endovascular therapy for CLTI.
Huynh K. Huynh K. Nat Rev Cardiol. 2023 Jan;20(1):5. doi: 10.1038/s41569-022-00817-3. Nat Rev Cardiol. 2023. PMID: 36418480 No abstract available.
Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) Trial: A Misleading Trial Name.
Takahashi EA, Lookstein RA, Misra S. Takahashi EA, et al. J Vasc Interv Radiol. 2023 Apr;34(4):718-719. doi: 10.1016/j.jvir.2023.01.005. Epub 2023 Jan 11. J Vasc Interv Radiol. 2023. PMID: 36639118 Free PMC article. No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia.
Roberts JD. Roberts JD. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920767 No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia.
Kida Y. Kida Y. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920768 No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia.
Farhan S, Vogel B, Krishnan P. Farhan S, et al. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920769 No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia.
Finn MT, Nair P, Walker C. Finn MT, et al. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920770 No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia.
Korosoglou G, Mustapha J, Zeller T. Korosoglou G, et al. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920771 No abstract available.
Surgery or Endovascular Therapy for Chronic Limb Ischemia. Reply.
Farber A, Rosenfield K, Menard MT. Farber A, et al. N Engl J Med. 2023 Mar 16;388(11):e37. doi: 10.1056/NEJMc2300713. N Engl J Med. 2023. PMID: 36920772 No abstract available.
The role of novel vascular conduits in the BEST-CLI trial era: An alternative for patients with inadequate saphenous vein.
Rasmussen TE, Shuja F, Cifuentes S. Rasmussen TE, et al. J Vasc Surg. 2023 May;77(5):1572. doi: 10.1016/j.jvs.2023.01.190. J Vasc Surg. 2023. PMID: 37087154 No abstract available.

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Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

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Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

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