First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis

Elwany, Mostafa; Latini, Roberto; Palma, Gaetano Di; Orrego, Pedro Silva

doi:10.1016/j.carrev.2017.03.020

Cited by 6 publications

(7 citation statements)

References 13 publications

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“…Understanding the fundamental pathophysiological mechanism underlying BRS failure is of key importance to guide proper subsequent treatment. 54) Therefore, intracoronary imaging study is highly recommended in cases of BRS failure. 55) Multiple treatment strategy for treating BRS failure was proposed including DES, plane balloon angioplasty, drug-coated balloon, or BRS.…”

Section: Treatment For Brs Failure (Scaffold Thrombosis and In-scaffomentioning

confidence: 99%

Bioresorbable Vascular Scaffold Korean Expert Panel Report

et al. 2017

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Bioresorbable vascular scaffold (BRS) is an innovative device that provides structural support and drug release to prevent early recoil or restenosis, and then degrades into nontoxic compounds to avoid late complications related with metallic drug-eluting stents (DESs). BRS has several putative advantages. However, recent randomized trials and registry studies raised clinical concerns about the safety and efficacy of first generation BRS. In addition, the general guidance for the optimal practice with BRS has not been suggested due to limited long-term clinical data in Korea. To address the safety and efficacy of BRS, we reviewed the clinical evidence of BRS implantation, and suggested the appropriate criteria for patient and lesion selection, scaffold implantation technique, and management.

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Section: Treatment For Brs Failure (Scaffold Thrombosis and In-scaffomentioning

confidence: 99%

Bioresorbable Vascular Scaffold Korean Expert Panel Report

et al. 2017

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“…Limited data are available in the literature on this topic (14,15). IScaR may be attributed to multiple factors which include: geographical miss (edge effect) defined as failure of the device to appropriately scaffold a balloon-injured vessel or to fully cover the lesion, scaffold underexpansion, scaffold gap (missing overlap of several mm), uneven scaffold implantation in tight stenosis, small target vessel diameter (<2 mm) (strut overcrowding), delayed scaffold resorption, excessive neointimal proliferation, neoatherosclerosis and resistance to antiproliferative drugs (16,17).…”

Section: Clinical Datamentioning

confidence: 99%

“…Follow-up coronary angiography at 12 months revealed failure in two patients which experienced type III restenosis. Both patients were treated with DES implantation (14).…”

Section: Treatment Of Bvs Failurementioning

confidence: 99%

Occurrence and management of bioresorbable vascular scaffold failure in real-life studies

Cortese

Elwany

2017

J. Thorac. Dis.

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Bioresorbable vascular scaffold (BVS) has emerged as a new technology aiming at overcoming some drawbacks of the conventional metallic stent. In spite of the initial promising results, this technology stumbled upon numerous challenges, which were revealed in the real world studies. Thanks to real world trials and registries findings, our knowledge about the BVS has grown over time, thus we have understood on BVS behavior in various settings and formulated better implantation techniques. In this article, we will review the incidence of BVS failure in real world studies, its different etiologies and management strategies.

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“…Furthermore, the Australian Therapeutic Goods Administration (TGA) on May 2, 2017[ 4 ] issued a hazard alert as well and recalled all BVS from medical centers not studying the device. These reactions[ 5 - 15 ] of the healthcare authorities amid few recently published meta-analyses[ 16 - 25 ] wreck confusion[ 26 - 37 ] among physicians[ 38 - 45 ] about when and if they will ever be using the device again, jeopardizing the future of BVS and further development of bioresorbable devices. Notwithstanding, did we clear the situation with causes of these trends toward increased MACE and ST in the case of BVS?…”

Section: Introductionmentioning

confidence: 99%

“…The running fourth industrial revolution[ 23 - 38 ] supports us with the remarkable idea of the transient scaffolding[ 39 - 51 ] and a dream of the vascular restoration therapy[ 25 ] of coronary atherosclerosis that has a potential to revolutionize cardiology providing physicians with a tackle for both to revitalize a circulation[ 20 - 36 ] in the coronary pool tailoring atheroregression[ 37 - 52 ]. Since 2006 the multimodality imaging studies of ABSORB[ 31 ] and ABSORB B[ 53 - 56 ] clinical trials that examined BVS have crashed to perform significant regression of atherosclerosis but with a trend toward absolute reduction of the percent atheroma volume (PAV) at 60 mo (at least -2.62%), which claims further research efforts.…”

Section: Introductionmentioning

confidence: 99%

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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First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis

Cited by 6 publications

References 13 publications

Bioresorbable Vascular Scaffold Korean Expert Panel Report

Bioresorbable Vascular Scaffold Korean Expert Panel Report

Occurrence and management of bioresorbable vascular scaffold failure in real-life studies

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

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