Scaffold thrombosis: Exaggerated illusion, or when statistics rules

Kharlamov, Alexander

doi:10.1016/j.ijcard.2016.02.054

Cited by 3 publications

(2 citation statements)

References 10 publications

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“…Current RCTs are being conducted with an underpowered design. In our previous analysis[ 12 ], we concluded that the meta-analyses were built on the non-significant data. Only a combo analysis of ABSORB III and ABSORB IV has a chance to clear those trends with ST in the near future (one-year results of ABSORB IV trial are expected before Spring 2018).…”

Section: Resultsmentioning

confidence: 99%

“…Our previous analysis[ 12 ] with a Funnel plot of the existing observational and randomized trials demonstrated that there is an unintentional bias with a lack of data from patients with metallic DES in order to compare and judge BVS properly. The meta-analysis of Polimeni et al[ 6 ] (five RCTs with 5219 patients) and Sorrentino et al[ 9 ] (seven RCTs with 5583 patients) observed similar trends of clinical outcomes and another Funnel plot analysis.…”

Section: Resultsmentioning

confidence: 99%

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

Kharlamov¹

2018

WJC

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

Kharlamov¹

2018

WJC

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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

Kharlamov¹,

Feinstein²,

Cramer³

et al. 2017

International Journal of Cardiology

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How Bioresorbable Vascular Can Be Beneficial for Patients in the Long-Term

2015

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Coronary artery disease (CAD) is the leading cause of mortality in patients ≥60 years old worldwide, and may result in stable angina, acute coronary syndromes (unstable angina or acute myocardial infarction), congestive heart failure, cardiac arrhythmia, or sudden death. A variety of medical therapies can treat the symptoms and arrest progression of CAD, but mechanical revascularisation of affected arteries is widely employed to ameliorate the symptoms of angina and improve prognosis, particularly in situations of multivessel disease, significant ischaemia, and in the setting of acute myocardial infarction. Rates of surgical revascularisation by coronary artery bypass graft surgery have gradually fallen over recent decades, with a concomitant rise in percutaneous coronary intervention procedures. Such minimally invasive techniques have evolved considerably in the last four decades, from plain old balloon angioplasty, through initial use of bare-metal stents to mitigate acute vessel closure, to the advent of drug-eluting stents designed and proven to reduce rates of restenosis. Bioresorbable vascular scaffolds/bioabsorbable stents are a new and promising generation of intravascular devices that may potentially circumvent many of the problems associated with such permanent metallic implants. This article will review available clinical trial and real-life data on the Absorb™ Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, California, USA), and highlight the potential utility of this novel class of devices in the management of patients with CAD.

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Scaffold thrombosis: Exaggerated illusion, or when statistics rules

Cited by 3 publications

References 10 publications

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

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

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

How Bioresorbable Vascular Can Be Beneficial for Patients in the Long-Term

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