In:
Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 8, No. 2 ( 2019-01-22)
Abstract:
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 . Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01408901.
Type of Medium:
Online Resource
ISSN:
2047-9980
DOI:
10.1161/JAHA.118.011001
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2019
detail.hit.zdb_id:
2653953-6
