WITHDRAWN: What exactly, regression of atherosclerosis or foreign body reaction with hyaline arteriosclerosis, drives transient scaffolding of coronary arteries? A pooled analysis of observational ABSORB studies with a serial multimodality imaging substudy of ABSORB cohort B1 trial

Kharlamov, Alexander; Feinstein, John Alexander; Cramer, John Alexander; Boothroyd, John A

doi:10.1016/j.ijcard.2017.05.134

Cited by 1 publication

(6 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The story of BVS looks like a curve of the Gartner Hype Cycle[ 34 ] (Figure 1 ). The innovation trigger of BVS technology began in 1988 when the team of Professor Richard S Stack from Duke University (Durham, NC) first reported in the American Journal of Cardiology about a PLLA bioabsorbable stent.…”

Section: Resultsmentioning

confidence: 99%

“…The innovation trigger of BVS technology began in 1988 when the team of Professor Richard S Stack from Duke University (Durham, NC) first reported in the American Journal of Cardiology about a PLLA bioabsorbable stent. There were no usable products, but it brought us to the next stage[ 34 ], Gartner’s peak of inflated expectations. This stage started in 2006 with the first publication in the Journal of Catheterization and Cardiovascular Interventions from the team of Professor Patrick W Serruys from Erasmus MC (Rotterdam, The Netherlands).…”

Section: Resultsmentioning

confidence: 99%

“…The bottom panel shows an example of the grey scale- and virtual histology-IVUS analyses in the five-year time-frame of the ABSORB trial highlighting a clear reduction of the plaque area and artery remodeling with the lumen enlargement and positive expansive remodeling of the vessel at least until 24 mo with the further constrictive-like remodeling. The figure was adapted from reference [ 34 ].…”

Section: Resultsmentioning

confidence: 99%

“…The figure was adapted from ref. [ 34 ]. n : Number of patients; MPA: Mean plaque area; abs: Absolute; rel: Relative; VH-TCFA: Virtual histology-thin-cap fibroatheroma; PB: plaque burden; VH-IVUS: virtual histology-intravascular ultrasound.…”

Section: Resultsmentioning

confidence: 99%

“…The figure was adapted from ref. [ 34 ]. n : Number of observations; PAV: Percent atheroma volume; R2: Coefficient of determination; r: Pearson correlation (for linear regression); IQR: Interquartile range; NS: Non-significant ( P > 0.05); PBSA: Plaque behind stent area; TAV: Total atheroma volume; MPA: Mean plaque area.…”

Section: Resultsmentioning

confidence: 99%

See 4 more Smart Citations

Undiscovered pathology of transient scaffolding remains a driver of failures in clinical trials

Kharlamov¹

2018

WJC

View full text Add to dashboard Cite

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, P > 0.05]. The underpowered design was confirmed for some studies such as ABSORB Japan, ABSORB China, EVERBIO II, AIDA trials, and meta-analyses of Polimeni, Collet, and Mahmoud with some unintentional bias (judged by the asymmetrical Funnel plot). Scaffold thrombosis rates with Absorb BRS were comparable with DES performed with a so-called strategy of the BVS implantation with optimized pre-dilation (P), sizing (S) and post-dilation (P) (PSP) implantation (RR, PSP vs no PSP 0.37) achieving 0.35 per 100 patient-years, which is comparable to the RR 0.49 with bare-metal stents and the RR 1.06 with everolimus DES. Both ABSORB II and ABSORB III trials were powered enough for a five-year follow-up, but the results were not entirely conclusive due to the mostly non-significant fashion of data. The powered meta-analyses were built mostly on statistically poor findings.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.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations