Vasorreatividade Coronariana após Reabsorção Total do Absorb BVS no Seguimento de 5 Anos

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

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Mid-term outcomes of the Absorb BVS versus second-generation DES: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0197119 ◽

2018 ◽

Vol 13 (5) ◽

pp. e0197119 ◽

Cited By ~ 11

Author(s):

Cordula M. Felix ◽

Victor J. van den Berg ◽

Sanne E. Hoeks ◽

Jiang Ming Fam ◽

Mattie Lenzen ◽

...

Keyword(s):

Systematic Review ◽

Second Generation ◽

Meta Analysis ◽

Absorb Bvs

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CRT-300.05 Impact of Intravascular Imaging Methods for Optimal Scaffold Implantation Reducing Thrombosis After Absorb Bvs in a Real World Setting: Identification of Factors Related to Stent Failure

JACC Cardiovascular Interventions ◽

10.1016/j.jcin.2018.01.120 ◽

2018 ◽

Vol 11 (4) ◽

pp. S37

Author(s):

Sergio G. Tarbine ◽

Costantino R. Costantini ◽

Costantino O. Costantini ◽

Marcelo F. Santos ◽

Daniel Anibal Zanuttini ◽

...

Keyword(s):

Real World ◽

Intravascular Imaging ◽

Imaging Methods ◽

Real World Setting ◽

Absorb Bvs

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Pre-Emptive OCT-Guided Angioplasty of Vulnerable Intermediate Coronary Lesions: Results from the Prematurely Halted PECTUS-Trial

Journal of Interventional Cardiology ◽

10.1155/2020/8821525 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Jan-Quinten Mol ◽

Michiel J. Bom ◽

Peter Damman ◽

Paul Knaapen ◽

Niels van Royen

Keyword(s):

Composite Endpoint ◽

Coronary Intervention ◽

Future Research ◽

Fractional Flow ◽

Bioresorbable Vascular Scaffold ◽

Flow Reserve ◽

Vulnerable Plaques ◽

Vascular Scaffolds ◽

Bioresorbable Vascular Scaffolds ◽

Absorb Bvs

Objectives. To assess the safety and efficacy of pre-emptive treatment of optical coherence tomography- (OCT-) derived vulnerable, non-flow-limiting, non-culprit lesions in patients with myocardial infarction (MI). Background. Intracoronary imaging with OCT can aid in the decision to treat non-flow-limiting lesions by identifying vulnerable plaques. Pre-emptive treatment of these lesions might improve patient outcome by “sealing” these plaques. Bioresorbable vascular scaffolds (BVS) have theoretical benefit for this treatment because they dissolve completely over time. Methods. In patients presenting with MI, non-culprit lesions with a fractional flow reserve ≥0.8 were imaged with OCT. Vulnerable plaques were randomised to either percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) placement or optimal medicinal therapy (OMT). The primary outcome was a composite of all-cause mortality, non-fatal MI, and unplanned revascularisation at 1-year follow-up. Results. The trial was stopped prematurely after retraction from the market of the Absorb BVS. At that time, a total of 34 patients were randomised. At two years, the composite endpoint occurred 3 times (18.8%) in the BVS group and 1 time (6.3%) in the OMT group. Apart from one elective PCI for stable angina in the OMT group, no target lesions in any group were revascularised. Conclusions. Pre-emptive stenting of vulnerable plaques had no evident benefit compared to conservative treatment. However, due to the low number of included patients, no definite conclusions could be drawn. Identifying and potentially treating vulnerable plaques remains an important target for future research. This trial is registered under https://www.trialregister.nl/trial/NL4177 on 08-12-2015.

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TCT-194 Impact of Intravascular Imaging Methods for Optimal Scaffold Implantation Reducing Thrombosis After Absorb BVS in a Real World Setting: Identification of Probable Factors Related to Stent Failure

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2018.08.1311 ◽

2018 ◽

Vol 72 (13) ◽

pp. B82

Author(s):

Costantino Costantini ◽

Sergio Tarbine ◽

Costantino Ortiz ◽

Marcelo Santos ◽

Marcos Denk ◽

...

Keyword(s):

Real World ◽

Intravascular Imaging ◽

Imaging Methods ◽

Real World Setting ◽

Absorb Bvs

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Understanding the Impact of Stent and Scaffold Material and Strut Design on Coronary Artery Thrombosis from the Basic and Clinical Points of View

Bioengineering ◽

10.3390/bioengineering5030071 ◽

2018 ◽

Vol 5 (3) ◽

pp. 71 ◽

Cited By ~ 19

Author(s):

Atsushi Sakamoto ◽

Hiroyuki Jinnouchi ◽

Sho Torii ◽

Renu Virmani ◽

Aloke Finn

Keyword(s):

Material Design ◽

Coronary Intervention ◽

Radial Force ◽

Late Time ◽

Clinical Complications ◽

Scaffold Thrombosis ◽

Absorb Bvs ◽

One Year ◽

The Impact

The technology of percutaneous coronary intervention (PCI) is constantly being refined in order to overcome the shortcomings of present day technologies. Even though current generation metallic drug-eluting stents (DES) perform very well in the short-term, concerns still exist about their long-term efficacy. Late clinical complications including late stent thrombosis (ST), restenosis, and neoatherosclerosis still exist and many of these events may be attributed to either the metallic platform and/or the drug and polymer left behind in the arterial wall. To overcome this limitation, the concept of totally bioresorbable vascular scaffolds (BRS) was invented with the idea that by eliminating long-term exposure of the vessel wall to the metal backbone, drug, and polymer, late outcomes would improve. The Absorb-bioabsorbable vascular scaffold (Absorb-BVS) represented the most advanced attempt to make such a device, with thicker struts, greater vessel surface area coverage and less radial force versus contemporary DES. Unfortunately, almost one year after its initial approval by the U.S. Food and Drug Administration, this scaffold was withdrawn from the market due to declining devise utilization driven by the concerns about scaffold thrombosis (ScT) seen in both early and late time points. Additionally, the specific causes of ScT have not yet been fully elucidated. In this review, we discuss the platform, vascular response, and clinical data of past and current metallic coronary stents with the Absorb-BVS and newer generation BRS, concentrating on their material/design and the mechanisms of thrombotic complications from the pre-clinical, pathologic, and clinical viewpoints.

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Scaffold Resorption Process Is Not the Achilles’ Heel of the Absorb BVS

JACC Basic to Translational Science ◽

10.1016/j.jacbts.2020.05.001 ◽

2020 ◽

Vol 5 (6) ◽

pp. 630-631

Author(s):

Laura S.M. Kerkmeijer ◽

Joanna J. Wykrzykowska

Keyword(s):

Absorb Bvs

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Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

Journal of Endovascular Therapy ◽

10.1177/1526602820922524 ◽

2020 ◽

Vol 27 (4) ◽

pp. 616-622

Author(s):

Steven Kum ◽

Jetty Ipema ◽

Derek Ho Chun-yin ◽

Darryl M. Lim ◽

Yih Kai Tan ◽

...

Keyword(s):

Wound Healing ◽

Primary Patency ◽

Tissue Loss ◽

Lesion Length ◽

Technical Success ◽

Bioresorbable Vascular Scaffold ◽

Index Procedure ◽

Free Survival ◽

Vascular Scaffold ◽

Absorb Bvs

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR ( Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

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