Racial differences in the effect of granulocyte macrophage colony-stimulating factor on improved walking distance in peripheral artery disease: The PROPEL randomized clinical trial
JournalJournal of the American Heart Association
PublisherAmerican Heart Association Inc.
MetadataShow full item record
AbstractBackground The effects of race on response to medical therapy in people with peripheral artery disease (PAD) are unknown. Methods and Results In the PROPEL (Progenitor Cell Release Plus Exercise to Improve Functional Performance in PAD) Trial, PAD participants were randomized to 1 of 4 groups for 6 months: supervised treadmill exercise+granulocyte‐macrophage colony‐stimulating factor (GM‐CSF) (Group 1), exercise+placebo (Group 2), attention control+GM‐CSF (Group 3), or attention control+placebo (Group 4). Change in 6‐minute walk distance was measured at 12‐ and 26‐week follow‐up. In these exploratory analyses, groups receiving GM‐CSF (Groups 1 and 3), placebo (Groups 2 and 4), exercise (Groups 1 and 2), and attention control (Groups 2 and 4) were combined, maximizing statistical power for studying the effects of race on response to interventions. Of 210 PAD participants, 141 (67%) were black and 64 (30%) were white. Among whites, GM‐CSF improved 6‐minute walk distance by +22.0 m (95% CI: −4.5, +48.5, P=0.103) at 12 weeks and +44.4 m (95% CI: +6.9, +82.0, P=0.020) at 26 weeks, compared with placebo. Among black participants, there was no effect of GM‐CSF on 6‐minute walk distance at 12‐week (P=0.26) or 26‐week (−5.0 m [−27.5, +17.5, P=0.66]) follow‐up, compared with placebo. There was an interaction of race on the effect of GM‐CSF on 6‐minute walk change at 26‐week follow‐up (P=0.018). Exercise improved 6‐minute walk distance in black (P=0.006) and white (P=0.034) participants without interaction. Conclusions GM‐CSF improved 6‐minute walk distance in whites with PAD but had no effect in black participants. Further study is needed to confirm racial differences in GM‐CSF efficacy in PAD. Copyright 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
SponsorsThis work was funded by the National Heart, Lung, and Blood Institute (R01-HL107510), was also supported by the intramural division of the National Institute on Aging and by Jesse Brown VA Medical Center.
Identifier to cite or link to this itemhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85060151089&doi=10.1161%2fJAHA.118.011001&partnerID=40&md5=5d818f426288ea8c6514c2ed66ba3b0a; http://hdl.handle.net/10713/8685
- Effect of Granulocyte-Macrophage Colony-Stimulating Factor With or Without Supervised Exercise on Walking Performance in Patients With Peripheral Artery Disease: The PROPEL Randomized Clinical Trial.
- Authors: McDermott MM, Ferrucci L, Tian L, Guralnik JM, Lloyd-Jones D, Kibbe MR, Polonsky TS, Domanchuk K, Stein JH, Zhao L, Taylor D, Skelly C, Pearce W, Perlman H, McCarthy W, Li L, Gao Y, Sufit R, Bloomfield CL, Criqui MH
- Issue date: 2017 Dec 5
- Effect of progenitor cell mobilization with granulocyte-macrophage colony-stimulating factor in patients with peripheral artery disease: a randomized clinical trial.
- Authors: Poole J, Mavromatis K, Binongo JN, Khan A, Li Q, Khayata M, Rocco E, Topel M, Zhang X, Brown C, Corriere MA, Murrow J, Sher S, Clement S, Ashraf K, Rashed A, Kabbany T, Neuman R, Morris A, Ali A, Hayek S, Oshinski J, Yoon YS, Waller EK, Quyyumi AA
- Issue date: 2013 Dec 25
- Progenitor cell release plus exercise to improve functional performance in peripheral artery disease: the PROPEL Study.
- Authors: Domanchuk K, Ferrucci L, Guralnik JM, Criqui MH, Tian L, Liu K, Losordo D, Stein J, Green D, Kibbe M, Zhao L, Annex B, Perlman H, Lloyd-Jones D, Pearce W, Taylor D, McDermott MM
- Issue date: 2013 Nov
- Durability of Benefits From Supervised Treadmill Exercise in People With Peripheral Artery Disease.
- Authors: McDermott MM, Kibbe MR, Guralnik JM, Ferrucci L, Criqui MH, Domanchuk K, Tian L, Zhao L, Li L, Patel K, Polonsky TS
- Issue date: 2019 Jan 8
- Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.
- Authors: Mehta A, Mavromatis K, Ko YA, Rogers SC, Dhindsa DS, Goodwin C, Patel R, Martini MA, Prasad M, Mokhtari A, Hesaroieh IG, Frohwein SC, Kutner MH, Harzand A, Wells BJ, Duwayri Y, Alabi O, Rajani RR, Brewster LP, Waller EK, Quyyumi AA
- Issue date: 2020 Apr