Trial reportBMC cardiovascular disorders2022
Analysis of the incidence and influencing factors associated with binary restenosis of target lesions after drug-coated balloon angioplasty for patients with in-stent restenosis.
Trial report in BMC cardiovascular disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04213378 (Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis), which is not on this map. Cited by 1 paper.
What it found
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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.
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.
Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis: a Randomized, Open-label, Positive Parallel Controlled, Multicenter Clinical Trial
Who cites it
1 citing paper in PubMed, 6 citations in OpenAlex.
- Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty.Frontiers in cardiovascular medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed.
methodsThe data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors.
resultsAll patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups (p < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939-17.567 P < 0.001) and length of lesion (OR:1.046 95% CI: 1.001-1.093 P = 0.046) were associated risk factors.
conclusionsThe longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings.
trial registrationNo.: NCT04213378, first posted date (30/12/2019).
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