ArticleWorld journal of cardiology2018
Undiscovered pathology of transient scaffolding t1remains a driver of failures in clinical trials.
Article in World journal of cardiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Sirolimus Release from Biodegradable Polymers for Coronary Stent Application: A Review.Pharmaceutics · 2022Review
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Authors and funding
1 author.
Funding
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Abstract
aimTo statistically examine the released clinical trials and meta-analyses of polymeric bioresorbable scaffolds resuming the main accomplishments in the field with a translation to the routine clinical practice.
methodsThe statistical power in clinical trials such as ABSORB Japan, ABSORB China, EVERBIO II, AIDA, and few meta-analyses by the post hoc odds ratio-based sample size calculation, and the patterns of artery remodeling published in papers from ABSORB A and B trials were evaluated.
resultsThe phenomenal admiration from the first ABSORB studies in 2006-2013 was replaced by the tremendous disappointment in 2014-2017 due to reported relatively higher rates of target lesion failure (a mean prevalence of 9.16%) and device thrombosis (2.38%) in randomized controlled trials. Otherwise, bioresorbable vascular scaffold (BVS) performs as well as the metallic drug-eluting stent (DES) with a trend toward some benefits for cardiac mortality [risk ratio (RR), 0.58-0.94,
conclusionThe misunderstanding of the pathology of transient scaffolding drives the failures of the clinical trials. More bench studies of the vascular response are required. Several next-generation BVS including multifunctional electronic scaffold grant cardiology with a huge promise to make BVS technology great again.
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Registered trials
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