Evidence map›Paper›PMID 34854580›Full record

ArticleKorean circulation journal2021

A First-in-Man Clinical Evaluation of Sirolimus and Ascorbic Acid-Eluting Stent Systems: a Multicenter, Subject-Blinded, Randomized Study.

Young-Hyo Lim, Ji Hyun Youn, Soon-Jun Hong, Tae-Hoon Ahn, Junghan Yoon, Jun-Kyu Park, Hyo-Soo Kim

Abstract read
In one paragraph

Article in Korean circulation journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

7 authors.

Young-Hyo Lim *Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-7203-7425
Ji Hyun Youn *CG Bio Co. Ltd., Seoul, Korea.ORCID https://orcid.org/0000-0003-2939-8457
Soon-Jun HongDivision of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0003-4832-6678
Tae-Hoon AhnDivision of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0003-1544-1784
Junghan YoonDepartment of Cardiology, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea.ORCID https://orcid.org/0000-0002-3363-2675
Jun-Kyu ParkCG Bio Co. Ltd., Seoul, Korea. pjk23@cgbio.co.kr.ORCID https://orcid.org/0000-0002-1587-5673
Hyo-Soo KimDepartment of Internal Medicine and Cardiovascular Center, Seoul National University College of Medicine, Seoul, Korea. hyosoo@snu.ac.kr.ORCID https://orcid.org/0000-0003-0847-5329

Funding

Medical Device Development Fund grantMinistry of Health and Welfare HI16C0994
6 · The paper itself

Abstract

BACKGROUND AND

objectivesThis clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES.

methodsThis study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5-4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks.

results57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32 mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES.

conclusionsThis study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.

Indexed as

Absorbable implantsAscorbic acidCoronary artery diseaseDrug-eluting stentsSirolimus

Identifiers

PMID34854580
PMCPMC8636762

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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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.