Evidence mapPaperPMID 35811708Full record

ArticleFrontiers in cardiovascular medicine2022

Appropriate Surrogate Endpoint in Drug-Coated Balloon Trials for Coronary Artery Diseases.

Xinyue Lang, Yang Wang, Wei Li, Xiaoyun Liu, Yanyan Zhao, Chuangshi Wang, Xiaocong Li, Yingxuan Zhu, Mengya Li, Lei Song and 1 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in cardiovascular medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Xinyue LangMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yang WangMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Wei LiMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xiaoyun LiuDepartment of Phase I Clinical Trail Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yanyan ZhaoMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Chuangshi WangMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xiaocong LiMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yingxuan ZhuMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Mengya LiMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lei SongDepartment of Cardiology, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Fu Wai Hospital, Beijing, China.
Bo XuDepartment of Cardiology, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Fu Wai Hospital, Beijing, China.
Fu Wai Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNCapital Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: 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: 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: 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: 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.

Indexed as

coronary artery diseasesdrug-coated balloons (DCBs)late lumen loss (LLL)minimal lumen diameter (MLD)percentage diameter stenosis (%DS)

Identifiers

PMID35811708
PMCPMC9256952
OpenAlexW4283259840

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.