1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

Stone, Gregg W.; Gao, Runlin; Kimura, Takeshi; Kereiakes, Dean J.; Ellis, Stephen G.; Onuma, Yoshinobu; Cheong, Wai-Fung; Jones-McMeans, Jennifer; Su, Xiaolu; Zhang, Zhen; Serruys, Patrick W.

doi:10.1016/s0140-6736(15)01039-9

Cited by 257 publications

(145 citation statements)

References 30 publications

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“…The risk for TLF was neutral between BVS and EES. In the 24 studies pooled, the estimated incidence rates of VLST, and ST through 2 years were higher in BVS than in EES (13).…”

Section: Clinical Datamentioning

confidence: 91%

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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“…The risk for TLF was neutral between BVS and EES. In the 24 studies pooled, the estimated incidence rates of VLST, and ST through 2 years were higher in BVS than in EES (13).…”

Section: Clinical Datamentioning

confidence: 91%

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

Cortese

Elwany

2017

J. Thorac. Dis.

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“…Also, the 1-year relative rates of the patientoriented composite endpoint did not differ significantly between BVS and EES in a recent patient-level, pooled meta-analysis including 3,389 patients with stable CAD or stabilized acute coronary syndrome (6). Despite the current promising results, there exists a concern of the increased rate of ST. For example, several registry based results, such as the GHOST-EU and BVS-EXAMINATION registry, have reported numerically higher thrombosis rates after BVS implantation [2.1% in the GHOST-EU registry (7), 2.4% in the BVS-EXAMINATION registry (8)].…”

Section: Bioresorbable Vascular Scaffolds (Bvs) As the Next Revolutiomentioning

confidence: 93%

How far have we come with bioresorbable vascular scaffolds, and where should we go?

Kang

Park

Kim

2017

Cardiovasc. Diagn. Ther.

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Bioresorbable vascular scaffolds (BVS) as the next revolution in interventional cardiologyTechnical advances in percutaneous coronary intervention (PCI) have had huge impact on the treatment of coronary artery disease (CAD). Current guidelines recommend drugeluting stent (DES) implantation as the standard care in CAD patients (1). However, even the newest generation DES have intrinsic limitations, such as the persistent risk of late stent failure, delayed chronic inflammation due to the polymer or metal components of stent, and loss of physiologic vasomotor function induced by the metal cage. Recently, BVS have emerged as an innovative tool to overcome the long-term complications of DESs. By applying a temporary scaffold, BVS provides adequate radial support to seal dissection, limit acute recoil and constrictive remodeling, whilst restoring normal vascular function after absorption.To date, a number of BVS have been tested in clinical trials (2), among which, the Absorb is the most-studied BVS. After safety confirmation by cohort based studies (3,4), a series of registry studies and randomized clinical trials (RCTs) have shown promising results for the Absorb BVS, being non-inferior to the everolimus-eluting stent (EES). BVS proved to have comparable safety and effectiveness outcomes at 1-year follow up. However interventional cardiologists are not yet comfortable in applying this novel technology daily practice because of several issues. First, there are concerns of an increased rate of scaffold thrombosis (ST). This may have been caused not only by the property of the scaffold, such as its thick 150 μm strut, but also by suboptimal deployment techniques such as the lack of intravascular imaging tool use or lack of postdilatation. Second, every doctor must pay attention to and adhere to the specific protocol of BVS deployment, which may be cumbersome and thus act as a practical hurdle in daily practice. Third, the indication for BVS is limited not only by lesion complexity but also by patients' general or local complexity. The performance of BVS has not been well tested in the complex lesions such as bifurcation or calcified tortuous lesions, or in the patients with diabetes or STEMI.Regarding the unsolved issues discussed above, Kraak et al. discussed the 2-year outcomes of Absorb BVS in a PCI population reflecting daily clinical practice (5). Of the 135 patients analyzed, 8% had chronic renal failure, 26% had previous PCI and 51% initially presented as acute coronary syndrome. Also, lesions included bifurcation (15%) and calcified lesions (11%). During the 2-year follow up period, event rates were cardiac death 0.7%, MI 5.3%, definite ST 3.0% and TVF 14.4%, respectively. By stratified analysis, patients who met the ABSORB II criteria and those with a SYNTAX score lower than the median value (11.5) had a significantly lower event rate. ST after BVS implantation

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“…Also, the available follow up was shorter in the meta-analysis of Lipinski et al (11), and in some cases there was a variation in endpoint definitions (i.e., myocardial infarction as opposed to target-vessel myocardial infarction; target lesion revascularization as opposed to ischemia-driven target lesion revascularization). The device-oriented clinical endpoint of TLF was appraised by only two meta-analyses (10,12) and shown to be similar between BVSs and EESs. Similarly, none of the meta-analyses displayed a difference in all-cause and cardiac death.…”

Section: Editorialmentioning

confidence: 99%

“…These latter include generating time-toevent curves, identifying independent prognostic factors, and testing for interaction effects. As such, the meta-analysis from Stone et al provides the reader with unique insightsfor example, over the distribution of TLF events at followup (i.e., with a steep rise in the first month, followed by continuous increase up to 12 months) and the detrimental impact of baseline conditions (i.e., diabetes, small vessels, and/or complex angiographic features) (10 their study with a trial sequential analysis indicating the lack of a strong evidence for a hypothetical 30% increase in device thrombosis with BVSs when compared with EESs, thus concluding that the current accumulated information size is underpowered to make any firm conclusions (13). Lipinski et al included more patients than did the other meta-analyses, extending their inclusion criteria to singlearm and case-control observational studies reflecting less selected populations than in the trial setting (11).…”

Section: Al ("Bvs Did Not Lead To Different Rates Of Composite Patiementioning

confidence: 99%

Overlapping meta-analyses of bioresorbable vascular scaffolds versus everolimus-eluting stents: bringing clarity or confusion?

Capodanno¹

2016

J. Thorac. Dis.

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1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

Cited by 257 publications

References 30 publications

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

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

How far have we come with bioresorbable vascular scaffolds, and where should we go?

Overlapping meta-analyses of bioresorbable vascular scaffolds versus everolimus-eluting stents: bringing clarity or confusion?

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