TCT-527 Long-term Clinical Outcomes of Patients Treated With The Everolimus-eluting Bioresorbable Vascular Scaffold. The BVS Expand Study

Felix, Cordula; Fam, Jiang-Ming; Onuma, Yoshinobu; Ishibashi, Yutaka; Everaert, Bert; Diletti, Roberto; Regar, Evelyn; Mieghem, Nicolás M. Van; Daemen, Joost; Jaegere, Peter de; Zijlstra, Felix; Geuns, Robert J. Van

doi:10.1016/j.jacc.2015.08.544

Cited by 9 publications

(11 citation statements)

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“…In a large, single-centre registry (BVS EXPAND) which reported outcomes with BVS beyond 1 year (median follow-up 622 days), major adverse cardiovascular events (MACE) at 18 months were 6.8% driven by MI 5.2%. Definite scaffold thrombosis was 1.9% with very late scaffold thrombosis rate of 1.3% 25. Under-expansion of BVS was a frequent finding (26%) with a trend towards increased MACE (HR 2.25, p=0.16).…”

Section: Discussionmentioning

confidence: 92%

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Nairooz

Saad

Sardar

et al. 2017

Heart

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Section: Discussionmentioning

confidence: 92%

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Nairooz

Saad

Sardar

et al. 2017

Heart

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“…Some recent studies have reported acceptable outcomes of BVS implantation in an extended population of candidates (i.e., patients with ST-elevation myocardial infarction or with complex lesions such as bifurcation or left main disease), indicating that the spectrum of BVS indication may be wider. 35 Regarding long lesions (>24 mm), in 1,002 patients the 1-year follow-up showed that DOCE antiplatelet therapy should be more actively considered because of the concern related to higher risk of ST in patients implanted with a BVS. Although various studies currently support the use of DAPT for <12 months after implantation of 2nd-generation DES, the same strategy should not be applied to patients implanted with a BVS.…”

Section: Bvs Implantation For Complex Lesionsmentioning

confidence: 99%

Bioresorbable Vascular Scaffolds　― Are We Facing a Time of Crisis or One of Breakthrough? ―

Kang

Han

Yang

et al. 2017

Circ J

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Current 2nd-generation drug-eluting stents (DES) have dramatically improved clinical outcomes after percutaneous coronary intervention for coronary artery disease. However, DES implantation has major long-term limitations related to the permanent presence of foreign material in the coronary artery. Bioresorbable vascular scaffolds (BVS) were designed to overcome this limitation of permanent metal-based DES. However, because of immature manufacturing technology, BVS have several drawbacks, such as the thicker strut, poor deliverability, poor radio-opacity, poor radial strength, and cumbersome procedure to meet the principle of PSP (Preparation, Sizing, and Post-dilatation). Initial studies indicated that BVS outcomes were non-inferior to those of current DES and recent follow-up data of trials have revealed an additional critical drawback, higher rate of scaffold thrombosis, on the top of the existing limitations of BVS. Thus attention must be paid to the appropriate BVS-specific implantation protocols (i.e., PSP), as well as adequate intensity and duration of dual antiplatelet therapy. In any case, current BVS need further technical evolution to replace current metallic DES in routine clinical use.

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“…To expand the spectrum of BVS, some recent studies have shown acceptable results of BVS in extended candidates (i.e., patients with ST elevation myocardial infarction or complex lesions such as bifurcation and left main diseases) (12,13 …”

Section: Bvs To Complex Lesionsmentioning

confidence: 99%

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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TCT-527 Long-term Clinical Outcomes of Patients Treated With The Everolimus-eluting Bioresorbable Vascular Scaffold. The BVS Expand Study

Cited by 9 publications

References 0 publications

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Bioresorbable Vascular Scaffolds　― Are We Facing a Time of Crisis or One of Breakthrough? ―

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

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TCT-527 Long-term Clinical Outcomes of Patients Treated With The Everolimus-eluting Bioresorbable Vascular Scaffold. The BVS Expand Study

Cited by 9 publications

References 0 publications

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis

Bioresorbable Vascular Scaffolds ― Are We Facing a Time of Crisis or One of Breakthrough? ―

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

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Product

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Bioresorbable Vascular Scaffolds　― Are We Facing a Time of Crisis or One of Breakthrough? ―