TY - JOUR
T1 - No benefit of vorapaxar on walking performance in patients with intermittent claudication
AU - Tsai, Shirling
AU - Liu, Yulun
AU - Alaiti, Mohamad Amer
AU - Gutierrez, Jorge Antonio
AU - Brilakis, Emmanouil S.
AU - Banerjee, Subhash
N1 - Funding Information:
The authors disclosed receipt of the following financial support for research, authorship, and/or publication of this article: This work was supported by a research grant from Merck & Co., Inc. and Aralez Pharmaceuticals R&D, Inc. All data analysis and manuscript preparation was performed independently of the sponsors.
Funding Information:
This material is the result of work supported with resources and the use of facilities at the VA North Texas Health Care Systems. The contents do not represent the views of the US Department of Veterans Affairs or the United States Government. We would like to acknowledge all of the participating site investigators and study coordinators who contributed to this work. This work was supported by a research grant from Merck & Co., Inc. and Aralez Pharmaceuticals R&D, Inc. All data analysis and manuscript preparation was performed independently of the sponsors.
Funding Information:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Shirling Tsai: none. Yulun Liu: none. Mohamad Amer Alaiti: none. Jorge Antonio Gutierrez: none. Emmanouil S Brilakis: consulting/speaker honoraria from Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens; owner: Hippocrates LLC; shareholder: MHI Ventures. Subhash Banerjee: consulting honoraria from Medtronic, Cordis, AngioSafe and Kaneka; research grants (institutional) from Boston Scientific Corporation, and Chiesi.
Publisher Copyright:
© The Author(s) 2021.
PY - 2022/2
Y1 - 2022/2
N2 - Background: The effect of pharmacologic agents in improving walking and quality of life measures in patients with intermittent claudication (IC) is variable. The objective of this study was to investigate the effect of the novel antithrombotic vorapaxar on symptom status in patients with IC. Methods: The study was a multicenter, randomized, placebo-controlled trial wherein patients with IC were treated with either vorapaxar or placebo in addition to a home exercise program for 6 months. Walking performance and quality of life were assessed by graded treadmill test (GTT) and 12-Item Short-Form Survey (SF-12), respectively, at baseline and at 6 months. A total of 102 subjects were randomized across 12 centers. Results: Of the subjects randomized, 66 completed all study assessments and comprised the dataset that was analyzed. After 6 months, there was no significant difference between the vorapaxar and placebo groups in walking performance, as reflected by the GTT, or in quality of life, as reflected by the SF-12. There were no severe bleeding events in either group. Conclusion: This study found no benefit of vorapaxar in patients with IC and reiterates the need for future drug therapy studies that expand the benefits of supervised exercise therapy in patients with IC. ClinicalTrials.gov Identifier: NCT02660866
AB - Background: The effect of pharmacologic agents in improving walking and quality of life measures in patients with intermittent claudication (IC) is variable. The objective of this study was to investigate the effect of the novel antithrombotic vorapaxar on symptom status in patients with IC. Methods: The study was a multicenter, randomized, placebo-controlled trial wherein patients with IC were treated with either vorapaxar or placebo in addition to a home exercise program for 6 months. Walking performance and quality of life were assessed by graded treadmill test (GTT) and 12-Item Short-Form Survey (SF-12), respectively, at baseline and at 6 months. A total of 102 subjects were randomized across 12 centers. Results: Of the subjects randomized, 66 completed all study assessments and comprised the dataset that was analyzed. After 6 months, there was no significant difference between the vorapaxar and placebo groups in walking performance, as reflected by the GTT, or in quality of life, as reflected by the SF-12. There were no severe bleeding events in either group. Conclusion: This study found no benefit of vorapaxar in patients with IC and reiterates the need for future drug therapy studies that expand the benefits of supervised exercise therapy in patients with IC. ClinicalTrials.gov Identifier: NCT02660866
KW - claudication
KW - peripheral artery disease (PAD)
KW - randomized controlled trial
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U2 - 10.1177/1358863X211042082
DO - 10.1177/1358863X211042082
M3 - Article
C2 - 34609939
AN - SCOPUS:85116496892
SN - 1358-863X
VL - 27
SP - 33
EP - 38
JO - Vascular Medicine (United Kingdom)
JF - Vascular Medicine (United Kingdom)
IS - 1
ER -