Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization
Authors: Menard Matthew T. , Farber Alik , Powell Richard J. , Rosenfield Kenneth , Conte Michael S. , Hamza Taye H. , Kaufman John A. , Cziraky Mark J. , Creager Mark A. , Dake Michael D. , Jaff Michael R. , Reid Diane , Sopko George , White Christopher J. , Strong Michael B. , van Over Max , Chisci Emiliano , Goodney Philip P. , Gray Bruce , Kayssi Ahmed , Siracuse Jeffrey J. , Choudhry Niteesh K. , Maurao Mick , Muluk Satish , Belkin Michael , Lyden Sean , Shishehbor Mehdi , Bajakian Danielle , Duwayri Yazan , Bowens Nina , Nypaver Timothy , Mukherjee Dipankar , Obrand Daniel , LaMuraglia Glenn , Kalra Manju , Bernardo Nelson , Barshes Neal , Lipsitz Evan , Jenkins J. Stephen , Gasper Warren , Owens Christopher , Pomposelli Frank , Rogers Kevin , Vouyouka Ageliki , Passman Marc , Pena Constantino , Ramaiah Venkatesh , Hoch John , Bersin Robert , Hayes Greg , Ho Karen , Shah Aamir , Lum Ying Wie , Darling R. Clement , Aalami Oliver , Zhou Wei , Patel Parag , Aziz Abdulhameed , Halloran Brian , Jung Enjae , Mitchell Erica , Turba Ulku Cenk , Choi Eric , Hiramoto Jade , Owens Christopher , Milner Ross , Crawford Robert , Ucuzian Areck , Henke Peter , Chaer Rabih , Lahiri (Adams) Julie , Gelabert Hugh , Safian Robert , Mena-Hurtado Carlos , Ihnat Daniel , Rowe Vincent , Kashyap Vikram , Shaw Palma , Korngold Ethan , Lindsay Thomas , Winkelaar Gerrit , Mell Matthew , DuVal Bruce , Aziz Faisal , Reed Amy , Nazzal Munier , Schanzer Andres , Hamdan Allen , Smeds Matthew , Kalish Jeffrey , Slaiby Jeffrey , Androes Mark , Hanover Tod , Motaganahalli Raghu , Chang Catherine , Hye Robert , Alexander Jason , Ansel Gary , Bohannon Todd , Desai Sapan , Hodgson Kim , Hood Douglas , Guzman Randolph Pl , Giles Kristina , Shah Samir , Hawkins Beau , Brothers Thomas Edward , Azizzadeh Ali , Charlton-Ouw Kristofer , Khan Sophia , Brooke Benjamin S. , Kabutey Nii-Kabu , Sachar Ravish , Dosluoglu Hasan , Berman Scott , Blebea John , Taubman Kevin , Douville Yvan , Cox Mitchell W. , Davis Joseph , Caps Michael , Schneider Peter , Abou-Zamzam Ahmed , Feldman Robert , von Mering Gregory , Tan Tze-Woei , Virk Chiranjiv S. , Zhang Wayne , Bacharach Michael , Seidman Craig , Iafrati Mark , Findeiss Laura , Bailey Charles , Shames Murray , Lane John , Baril Donald , Hass Stephen , Stone Patrick , Sharma Aditya , Tracci Margaret , Mackenzie Kent , Stoner Michael , Starr Jean , McAllister David , Singh Niten , Tsai Shirling , Kinlay Scott , Macsata Robyn , Neville Richard , Rundback John , McGinigle Kate , Vallabhaneni Raghu , Espinoza Andrey , Azarbal Amir , Longo G. Matthew , Kovach Richard , Soukas Peter , Metzger Chris , Artis Andre , Bachinsky William , Armstrong Ehrin , Hattler Brack , Chandra Venita , Schor Jonathan , Bianchi Christian , Kiang Sharon , Ben-Arie Eyal , Verta Michael , Wilkinson Julia , Hurie Justin , Kopriva David , Molnar Robert , Chun Linda Jun , Azene Ezana , Davis Clark , Blazick Elizabeth , Henao Steve , Proffitt Trent , Herman Christine , Nathan Derek , Chang Robert , Lane John , Mureebe Leila , Chen Jerry , Semel Marcus , Fecteau Scott , Mehta Manish , Nagpal Sudhir , Shammas Nicolas , Kujath Scott , Beasley Robert , Vogel Todd , Hedayati Nasim , Brooks James , Nelson Peter , Parrack Inkyong , Bernik Thomas , Dexter David , Brown Kellie , Huang Joe , Wu Timothy , Hacker Robert , Garland Brandon Tyler , Griffin Joseph , Laskowski Igor , Pfau Steven , Duncan Audra , Trachtenberg Jeffrey , Gordon Ian , Tan Tze-Woei , Aulivola Bernadette , Zayed Mohamed , Venermo Maarit , Hill Andrew , Wickremesekera Janaka Kesara , Ketteler Erika , Michelagnoli Stefano , Bannazadeh Mohsen , Sikalas Nicholas , Khashram Manar , Vasudevan Thodur , Simmons Justin , Osborne Nicholas , Fox Charles , Vallabhaneni Raghuveer 
Published: April 2024

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.