Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

Matthew T. Menard; Alik Farber; Richard J. Powell; Kenneth Rosenfield; Michael S. Conte; Taye H. Hamza; John A. Kaufman; Mark J. Cziraky; Mark A. Creager; Michael D. Dake; Michael R. Jaff; Diane Reid; George Sopko; Christopher J. White; Michael B. Strong; Max Van Over; Emiliano Chisci; Philip P. Goodney; Bruce Gray; Ahmed Kayssi; Jeffrey J. Siracuse; Niteesh K. Choudhry; Mick Maurao; Satish Muluk; Michael Belkin; Sean Lyden; Mehdi Shishehbor; Danielle Bajakian; 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 Wie Lum; R. Clement Darling; 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; 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 Edward 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; Mohsen Bannazadeh; Nicholas Sikalas; Manar Khashram; Thodur Vasudevan; Justin Simmons; Nicholas Osborne; Charles Fox; Raghuveer Vallabhaneni

doi:10.1161/CIRCULATIONAHA.123.065277

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

Matthew T. Menard, Alik Farber, Richard J. Powell, Kenneth Rosenfield, Michael S. Conte, Taye H. Hamza, John A. Kaufman, Mark J. Cziraky, Mark A. Creager, Michael D. Dake, Michael R. Jaff, Diane Reid, George Sopko, Christopher J. White, Michael B. Strong, Max Van Over, Emiliano Chisci, Philip P. Goodney, Bruce Gray, Ahmed KayssiJeffrey J. Siracuse, Niteesh K. Choudhry, Mick Maurao, Satish Muluk, Michael Belkin, Sean Lyden, Mehdi Shishehbor, Danielle Bajakian, 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 Wie Lum, R. Clement Darling, 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, 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 Edward 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, Mohsen Bannazadeh, Nicholas Sikalas, Manar Khashram, Thodur Vasudevan, Justin Simmons, Nicholas Osborne, Charles Fox, Raghuveer Vallabhaneni

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Original language	English (US)
Pages (from-to)	1241-1253
Number of pages	13
Journal	Circulation
Volume	149
Issue number	16
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.123.065277
State	Published - Apr 16 2024

Keywords

critical limb-threatening ischemia
minimal clinically important difference
peripheral arterial disease
quality of life
randomized controlled trial
saphenous vein

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

Access to Document

10.1161/CIRCULATIONAHA.123.065277

Cite this

Menard, M. T., Farber, A., Powell, R. J., Rosenfield, K., Conte, M. S., Hamza, T. H., Kaufman, J. A., Cziraky, M. J., Creager, M. A., Dake, M. D., Jaff, M. R., Reid, D., Sopko, G., White, C. J., Strong, M. B., Van Over, M., Chisci, E., Goodney, P. P., Gray, B., ... Vallabhaneni, R. (2024). Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization. Circulation, 149(16), 1241-1253. https://doi.org/10.1161/CIRCULATIONAHA.123.065277

Menard, MT, Farber, A, Powell, RJ, Rosenfield, K, Conte, MS, Hamza, TH, Kaufman, JA, Cziraky, MJ, Creager, MA, Dake, MD, Jaff, MR, Reid, D, Sopko, G, White, CJ, Strong, MB, Van Over, M, Chisci, E, Goodney, PP, Gray, B, Kayssi, A, Siracuse, JJ, Choudhry, NK, Maurao, M, Muluk, S, Belkin, M, Lyden, S, Shishehbor, M, Bajakian, D, Duwayri, Y, Bowens, N, Nypaver, T, Mukherjee, D, Obrand, D, Lamuraglia, G, Kalra, M, Bernardo, N, Barshes, N, Lipsitz, E, Jenkins, JS, Gasper, W, Owens, C, Pomposelli, F, Rogers, K, Vouyouka, A, Passman, M, Pena, C, Ramaiah, V, Hoch, J, Bersin, R, Hayes, G, Ho, K, Shah, A, Lum, YW, Darling, RC, Aalami, O, Zhou, W, Patel, P, Aziz, A, Halloran, B, Jung, E, Mitchell, E, Turba, UC, Choi, E, Hiramoto, J, Milner, R, Crawford, R, Ucuzian, A, Henke, P, Chaer, R, Lahiri, J, Gelabert, H, Safian, R, Mena-Hurtado, C, Ihnat, D, Rowe, V, Kashyap, V, Shaw, P, Korngold, E, Lindsay, T, Winkelaar, G, Mell, M, Duval, B, Aziz, F, Reed, A, Nazzal, M, Schanzer, A, Hamdan, A, Smeds, M, Kalish, J, Slaiby, J, Androes, M, Hanover, T, Motaganahalli, R, Chang, C, Hye, R, Alexander, J, Ansel, G, Bohannon, T, Desai, S, Hodgson, K, Hood, D, Guzman, RP, Giles, K, Shah, S, Hawkins, B, Brothers, TE, Azizzadeh, A, Charlton-Ouw, K, Khan, S, Brooke, BS, Kabutey, NK, Sachar, R, Dosluoglu, H, Berman, S, Blebea, J, Taubman, K, Douville, Y, Cox, MW, Davis, J, Caps, M, Schneider, P, Abou-Zamzam, A, Feldman, R, Von Mering, G, Tan, TW, Virk, CS, Zhang, W, Bacharach, M, Seidman, C, Iafrati, M, Findeiss, L, Bailey, C, Shames, M, Lane, J, Baril, D, Hass, S, Stone, P, Sharma, A, Tracci, M, Mackenzie, K, Stoner, M, Starr, J, Mcallister, D, Singh, N, Tsai, S, Kinlay, S, Macsata, R, Neville, R, Rundback, J, Mcginigle, K, Vallabhaneni, R, Espinoza, A, Azarbal, A, Longo, GM, Kovach, R, Soukas, P, Metzger, C, Artis, A, Bachinsky, W, Armstrong, E, Hattler, B, Chandra, V, Schor, J, Bianchi, C, Kiang, S, Ben-Arie, E, Verta, M, Wilkinson, J, Hurie, J, Kopriva, D, Molnar, R, Chun, LJ, Azene, E, Davis, C, Blazick, E, Henao, S, Proffitt, T, Herman, C, Nathan, D, Chang, R, Mureebe, L, Chen, J, Semel, M, Fecteau, S, Mehta, M, Nagpal, S, Shammas, N, Kujath, S, Beasley, R, Vogel, T, Hedayati, N, Brooks, J, Nelson, P, Parrack, I, Bernik, T, Dexter, D, Brown, K, Huang, J, Wu, T, Hacker, R, Garland, BT, Griffin, J, Laskowski, I, Pfau, S, Duncan, A, Trachtenberg, J, Gordon, I, Aulivola, B, Zayed, M, Venermo, M, Hill, A, Wickremesekera, JK, Ketteler, E, Michelagnoli, S, Bannazadeh, M, Sikalas, N, Khashram, M, Vasudevan, T, Simmons, J, Osborne, N, Fox, C & Vallabhaneni, R 2024, 'Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization', Circulation, vol. 149, no. 16, pp. 1241-1253. https://doi.org/10.1161/CIRCULATIONAHA.123.065277

@article{8dae4c3098a845bc84d17f847c85288e,

title = "Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization",

abstract = "Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.",

keywords = "critical limb-threatening ischemia, minimal clinically important difference, peripheral arterial disease, quality of life, randomized controlled trial, saphenous vein",

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

year = "2024",

month = apr,

day = "16",

doi = "10.1161/CIRCULATIONAHA.123.065277",

language = "English (US)",

volume = "149",

pages = "1241--1253",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "16",

}

TY - JOUR

T1 - Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

AU - Menard, Matthew T.

AU - Farber, Alik

AU - Powell, Richard J.

AU - Rosenfield, Kenneth

AU - Conte, Michael S.

AU - Hamza, Taye H.

AU - Kaufman, John A.

AU - Cziraky, Mark J.

AU - Creager, Mark A.

AU - Dake, Michael D.

AU - Jaff, Michael R.

AU - Reid, Diane

AU - Sopko, George

AU - White, Christopher J.

AU - Strong, Michael B.

AU - Van Over, Max

AU - Chisci, Emiliano

AU - Goodney, Philip P.

AU - Gray, Bruce

AU - Kayssi, Ahmed

AU - Siracuse, Jeffrey J.

AU - Choudhry, Niteesh K.

AU - Maurao, Mick

AU - Muluk, Satish

AU - Belkin, Michael

AU - Lyden, Sean

AU - Shishehbor, Mehdi

AU - Bajakian, Danielle

AU - Duwayri, Yazan

AU - Bowens, Nina

AU - Nypaver, Timothy

AU - Mukherjee, Dipankar

AU - Obrand, Daniel

AU - Lamuraglia, Glenn

AU - Kalra, Manju

AU - Bernardo, Nelson

AU - Barshes, Neal

AU - Lipsitz, Evan

AU - Jenkins, J. Stephen

AU - Gasper, Warren

AU - Owens, Christopher

AU - Pomposelli, Frank

AU - Rogers, Kevin

AU - Vouyouka, Ageliki

AU - Passman, Marc

AU - Pena, Constantino

AU - Ramaiah, Venkatesh

AU - Hoch, John

AU - Bersin, Robert

AU - Hayes, Greg

AU - Ho, Karen

AU - Shah, Aamir

AU - Lum, Ying Wie

AU - Darling, R. Clement

AU - Aalami, Oliver

AU - Zhou, Wei

AU - Patel, Parag

AU - Aziz, Abdulhameed

AU - Halloran, Brian

AU - Jung, Enjae

AU - Mitchell, Erica

AU - Turba, Ulku Cenk

AU - Choi, Eric

AU - Hiramoto, Jade

AU - Milner, Ross

AU - Crawford, Robert

AU - Ucuzian, Areck

AU - Henke, Peter

AU - Chaer, Rabih

AU - Lahiri, Julie

AU - Gelabert, Hugh

AU - Safian, Robert

AU - Mena-Hurtado, Carlos

AU - Ihnat, Daniel

AU - Rowe, Vincent

AU - Kashyap, Vikram

AU - Shaw, Palma

AU - Korngold, Ethan

AU - Lindsay, Thomas

AU - Winkelaar, Gerrit

AU - Mell, Matthew

AU - Duval, Bruce

AU - Aziz, Faisal

AU - Reed, Amy

AU - Nazzal, Munier

AU - Schanzer, Andres

AU - Hamdan, Allen

AU - Smeds, Matthew

AU - Kalish, Jeffrey

AU - Slaiby, Jeffrey

AU - Androes, Mark

AU - Hanover, Tod

AU - Motaganahalli, Raghu

AU - Chang, Catherine

AU - Hye, Robert

AU - Alexander, Jason

AU - Ansel, Gary

AU - Bohannon, Todd

AU - Desai, Sapan

AU - Hodgson, Kim

AU - Hood, Douglas

AU - Guzman, Randolph Pl

AU - Giles, Kristina

AU - Shah, Samir

AU - Hawkins, Beau

AU - Brothers, Thomas Edward

AU - Azizzadeh, Ali

AU - Charlton-Ouw, Kristofer

AU - Khan, Sophia

AU - Brooke, Benjamin S.

AU - Kabutey, Nii Kabu

AU - Sachar, Ravish

AU - Dosluoglu, Hasan

AU - Berman, Scott

AU - Blebea, John

AU - Taubman, Kevin

AU - Douville, Yvan

AU - Cox, Mitchell W.

AU - Davis, Joseph

AU - Caps, Michael

AU - Schneider, Peter

AU - Abou-Zamzam, Ahmed

AU - Feldman, Robert

AU - Von Mering, Gregory

AU - Tan, Tze Woei

AU - Virk, Chiranjiv S.

AU - Zhang, Wayne

AU - Bacharach, Michael

AU - Seidman, Craig

AU - Iafrati, Mark

AU - Findeiss, Laura

AU - Bailey, Charles

AU - Shames, Murray

AU - Lane, John

AU - Baril, Donald

AU - Hass, Stephen

AU - Stone, Patrick

AU - Sharma, Aditya

AU - Tracci, Margaret

AU - Mackenzie, Kent

AU - Stoner, Michael

AU - Starr, Jean

AU - Mcallister, David

AU - Singh, Niten

AU - Tsai, Shirling

AU - Kinlay, Scott

AU - Macsata, Robyn

AU - Neville, Richard

AU - Rundback, John

AU - Mcginigle, Kate

AU - Vallabhaneni, Raghu

AU - Espinoza, Andrey

AU - Azarbal, Amir

AU - Longo, G. Matthew

AU - Kovach, Richard

AU - Soukas, Peter

AU - Metzger, Chris

AU - Artis, Andre

AU - Bachinsky, William

AU - Armstrong, Ehrin

AU - Hattler, Brack

AU - Chandra, Venita

AU - Schor, Jonathan

AU - Bianchi, Christian

AU - Kiang, Sharon

AU - Ben-Arie, Eyal

AU - Verta, Michael

AU - Wilkinson, Julia

AU - Hurie, Justin

AU - Kopriva, David

AU - Molnar, Robert

AU - Chun, Linda Jun

AU - Azene, Ezana

AU - Davis, Clark

AU - Blazick, Elizabeth

AU - Henao, Steve

AU - Proffitt, Trent

AU - Herman, Christine

AU - Nathan, Derek

AU - Chang, Robert

AU - Mureebe, Leila

AU - Chen, Jerry

AU - Semel, Marcus

AU - Fecteau, Scott

AU - Mehta, Manish

AU - Nagpal, Sudhir

AU - Shammas, Nicolas

AU - Kujath, Scott

AU - Beasley, Robert

AU - Vogel, Todd

AU - Hedayati, Nasim

AU - Brooks, James

AU - Nelson, Peter

AU - Parrack, Inkyong

AU - Bernik, Thomas

AU - Dexter, David

AU - Brown, Kellie

AU - Huang, Joe

AU - Wu, Timothy

AU - Hacker, Robert

AU - Garland, Brandon Tyler

AU - Griffin, Joseph

AU - Laskowski, Igor

AU - Pfau, Steven

AU - Duncan, Audra

AU - Trachtenberg, Jeffrey

AU - Gordon, Ian

AU - Aulivola, Bernadette

AU - Zayed, Mohamed

AU - Venermo, Maarit

AU - Hill, Andrew

AU - Wickremesekera, Janaka Kesara

AU - Ketteler, Erika

AU - Michelagnoli, Stefano

AU - Bannazadeh, Mohsen

AU - Sikalas, Nicholas

AU - Khashram, Manar

AU - Vasudevan, Thodur

AU - Simmons, Justin

AU - Osborne, Nicholas

AU - Fox, Charles

AU - Vallabhaneni, Raghuveer

PY - 2024/4/16

Y1 - 2024/4/16

N2 - Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

AB - Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

KW - critical limb-threatening ischemia

KW - minimal clinically important difference

KW - peripheral arterial disease

KW - quality of life

KW - randomized controlled trial

KW - saphenous vein

UR - http://www.scopus.com/inward/record.url?scp=85190901618&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85190901618&partnerID=8YFLogxK

U2 - 10.1161/CIRCULATIONAHA.123.065277

DO - 10.1161/CIRCULATIONAHA.123.065277

M3 - Article

C2 - 38597097

AN - SCOPUS:85190901618

SN - 0009-7322

VL - 149

SP - 1241

EP - 1253

JO - Circulation

JF - Circulation

IS - 16

ER -

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

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