Appropriate Surrogate Endpoint in Drug-Coated Balloon Trials for Coronary Artery Diseases.
coronary artery diseases
drug-coated balloons (DCBs)
late lumen loss (LLL)
minimal lumen diameter (MLD)
percentage diameter stenosis (%DS)
Journal
Frontiers in cardiovascular medicine
ISSN: 2297-055X
Titre abrégé: Front Cardiovasc Med
Pays: Switzerland
ID NLM: 101653388
Informations de publication
Date de publication:
2022
2022
Historique:
received:
16
03
2022
accepted:
24
05
2022
entrez:
11
7
2022
pubmed:
12
7
2022
medline:
12
7
2022
Statut:
epublish
Résumé
The appropriateness of using late lumen loss (LLL) as a surrogate endpoint was established in drug-eluting stent (DES) studies, but it was less supportive for drug-coated balloon (DCB) trials. Studies published until 23 June 2021 were searched from PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov. The correlation between LLL, MLD (minimal lumen diameter), and %DS (percentage diameter stenosis) and clinical endpoints was evaluated by linear regression. Standardized effect size and its 95% CIs were used to illustrate the difference among LLL, MLD, and %DS. A total of 24 clinical trials were eligible [16 DCB vs. DES, 7 DCB vs. plain old balloon angioplasty (POBA), and 1 DCB vs. DES vs. POBA]. Thirteen (54.2%) trials used LLL as the primary endpoint. LLL, MLD, and %DS all had significant associations with clinical endpoints. For DCB vs. DES trials, the number of studies that reported inconsistent results between LLL and MLD was 12/16 (75.0%) and between LLL and %DS was 10/15 (66.7%), while in MLD and %DS, it was 1/16 (6.3%). The difference of standardized effect size between LLL and MLD was -0.47 (95% CI, -0.69 to -0.25, For DCB trials, an appropriate surrogate is associated with the control device. The traditional LLL could be used in the DCB vs. POBA trials. However, MLD/%DS should be considered a more suitable surrogate endpoint when comparing DCB with DES.
Sections du résumé
Background
UNASSIGNED
The appropriateness of using late lumen loss (LLL) as a surrogate endpoint was established in drug-eluting stent (DES) studies, but it was less supportive for drug-coated balloon (DCB) trials.
Methods
UNASSIGNED
Studies published until 23 June 2021 were searched from PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov. The correlation between LLL, MLD (minimal lumen diameter), and %DS (percentage diameter stenosis) and clinical endpoints was evaluated by linear regression. Standardized effect size and its 95% CIs were used to illustrate the difference among LLL, MLD, and %DS.
Results
UNASSIGNED
A total of 24 clinical trials were eligible [16 DCB vs. DES, 7 DCB vs. plain old balloon angioplasty (POBA), and 1 DCB vs. DES vs. POBA]. Thirteen (54.2%) trials used LLL as the primary endpoint. LLL, MLD, and %DS all had significant associations with clinical endpoints. For DCB vs. DES trials, the number of studies that reported inconsistent results between LLL and MLD was 12/16 (75.0%) and between LLL and %DS was 10/15 (66.7%), while in MLD and %DS, it was 1/16 (6.3%). The difference of standardized effect size between LLL and MLD was -0.47 (95% CI, -0.69 to -0.25,
Conclusions
UNASSIGNED
For DCB trials, an appropriate surrogate is associated with the control device. The traditional LLL could be used in the DCB vs. POBA trials. However, MLD/%DS should be considered a more suitable surrogate endpoint when comparing DCB with DES.
Identifiants
pubmed: 35811708
doi: 10.3389/fcvm.2022.897365
pmc: PMC9256952
doi:
Types de publication
Journal Article
Langues
eng
Pagination
897365Informations de copyright
Copyright © 2022 Lang, Wang, Li, Liu, Zhao, Wang, Li, Zhu, Li, Song and Xu.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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