A double-blind, randomized, placebo-controlled pilot trial to evaluate safety and efficacy of vorapaxar on arteriovenous fistula maturation.
Aged
Arteriovenous Shunt, Surgical
/ adverse effects
California
Double-Blind Method
Early Termination of Clinical Trials
Female
Hemorrhage
/ chemically induced
Humans
Kidney Failure, Chronic
/ diagnosis
Lactones
/ adverse effects
Male
Middle Aged
Pilot Projects
Platelet Aggregation Inhibitors
/ adverse effects
Pyridines
/ adverse effects
Receptor, PAR-1
/ antagonists & inhibitors
Renal Dialysis
/ adverse effects
Risk Factors
Time Factors
Treatment Outcome
Upper Extremity
/ blood supply
Arteriovenous fistula
VorapAccess
clinical trial
dialysis
thrombin
vorapaxar
Journal
The journal of vascular access
ISSN: 1724-6032
Titre abrégé: J Vasc Access
Pays: United States
ID NLM: 100940729
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
pubmed:
28
11
2019
medline:
29
9
2020
entrez:
28
11
2019
Statut:
ppublish
Résumé
Protease-activated receptor-1 antagonism by vorapaxar could facilitate arteriovenous fistula maturation but may increase bleeding risk. The primary objective of the Vorapaxar Study for Maturation of arteriovenous fistula for Hemodialysis Access (VorapAccess) was to determine if vorapaxar improves arteriovenous fistula functional maturation in patients with end-stage renal disease. VorapAccess was a randomized, placebo-controlled, double-blind pilot trial comparing 2.5 mg vorapaxar per day with placebo for twelve weeks starting on day two after arteriovenous fistula creation. The primary outcome was time to functional maturation defined as successful cannulation for six hemodialysis sessions within three weeks. The planned sample size was 50 participants. The study was terminated early after withdrawal of planned financial support. Given the small number of randomized patients, we performed descriptive analyses without inference testing. A total of 13 participants were randomly allocated study drug (six vorapaxar and seven placebo). The median age was 56 years and seven participants (54%) were female. The median (minimum-maximum) days to functional maturation were 169 (77-287) days in the vorapaxar group and 145 (48-198) days in the placebo group. Six of the 13 (46%) participants had arteriovenous fistula functional maturation within 180 days; two of six (33%) in the vorapaxar group and four of seven (57%) in the placebo group. There was one bleeding event in the placebo group. Fewer than half of participants had functional maturation within 180 days after surgery, suggesting a major need for agents or strategies that enhance arteriovenous fistula maturation.
Sections du résumé
BACKGROUND
BACKGROUND
Protease-activated receptor-1 antagonism by vorapaxar could facilitate arteriovenous fistula maturation but may increase bleeding risk.
OBJECTIVE
OBJECTIVE
The primary objective of the Vorapaxar Study for Maturation of arteriovenous fistula for Hemodialysis Access (VorapAccess) was to determine if vorapaxar improves arteriovenous fistula functional maturation in patients with end-stage renal disease.
METHODS
METHODS
VorapAccess was a randomized, placebo-controlled, double-blind pilot trial comparing 2.5 mg vorapaxar per day with placebo for twelve weeks starting on day two after arteriovenous fistula creation. The primary outcome was time to functional maturation defined as successful cannulation for six hemodialysis sessions within three weeks. The planned sample size was 50 participants. The study was terminated early after withdrawal of planned financial support. Given the small number of randomized patients, we performed descriptive analyses without inference testing.
RESULTS
RESULTS
A total of 13 participants were randomly allocated study drug (six vorapaxar and seven placebo). The median age was 56 years and seven participants (54%) were female. The median (minimum-maximum) days to functional maturation were 169 (77-287) days in the vorapaxar group and 145 (48-198) days in the placebo group. Six of the 13 (46%) participants had arteriovenous fistula functional maturation within 180 days; two of six (33%) in the vorapaxar group and four of seven (57%) in the placebo group. There was one bleeding event in the placebo group.
CONCLUSION
CONCLUSIONS
Fewer than half of participants had functional maturation within 180 days after surgery, suggesting a major need for agents or strategies that enhance arteriovenous fistula maturation.
Identifiants
pubmed: 31774037
doi: 10.1177/1129729819887269
pmc: PMC8063544
mid: NIHMS1682370
doi:
Substances chimiques
Lactones
0
Platelet Aggregation Inhibitors
0
Pyridines
0
Receptor, PAR-1
0
vorapaxar
ZCE93644N2
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
467-474Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK116074
Pays : United States
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