Absorb (everolimus-eluting bioresorbable vascular scaffold) / Abbott - LARVOL DELTA

Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. (PubMed, JACC Cardiovasc Interv) - P=N/A | "Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold [Absorb™ BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379)."

Clinical • Journal • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Myocardial Infarction • Thrombosis

Five-year clinical outcomes of STEMI patients treated with a pre-specified bioresorbable vascular scaffold implantation technique: Final results of the BVS STEMI STRATEGY-IT. (PubMed, Cardiovasc Revasc Med) - P4 | "This study shows favorable 5-year outcomes for BVS in selected STEMI patients with an optimized implantation strategy. Prolonged DAPT further improved outcomes, emphasizing its role in reducing adverse events during scaffold resorption. Further research is needed to assess newer-generation bioresorbable devices."

Clinical data • Journal • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

A Decade Later: Unveiling Long-Term Coronary Artery healing with Optical Coherence Tomography Following Bioresorbable-Scaffold Implantation. (PubMed, Can J Cardiol) - No abstract available

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia

Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial. (PubMed, Front Cardiovasc Med) - P4 | "The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blinded, randomized controlled trial that enrolled 240 patients allocated in a 1:1:1 ratio to receive BVSs, everolimus-eluting stents, or biolimus-eluting stents (BESs). Over 10 years, the rates of clinical DOCE and POCE were similar between the BVS and DES groups but individual outcomes of stent thrombosis were higher (3%) in the BVS group compared to the DES group. ClinicalTrials.gov, identifier (NCT01711931)."

Clinical data • Journal • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Myocardial Infarction • Thrombosis

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease: A Literature Review of New Developments. (PubMed, Rev Cardiovasc Med) - "The ABSORB BVS is the most studied BVS in cardiovascular disease (CAD)...However, current evidence does not yet allow for a universal recommendation for their use. Thus, ongoing, and future studies, such as those examining the newer generation of bioresorbable scaffolds (BRSs) with improved mechanical properties and resorption profiles, will be crucial in defining the role of BRSs in managing PAD."

Journal • Review • Cardiovascular • Hematological Disorders • Peripheral Arterial Disease • Thrombosis

Long-term outcomes following bioresorbable vascular scaffolds. (PubMed, Expert Rev Cardiovasc Ther) - "It updates the long-term clinical outcomes of trials evaluating the ABSORB BVS and metallic alloy based BRS. In addition, it reviews the next-generation BRSs manufactured in Asia. Critical areas to improve the performance and safety of biodegradable scaffolds include further development in material science, surface modification, delivery systems, and long-term follow-up studies."

Journal • Review • Cardiovascular • Hematological Disorders • Thrombosis

Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART). (PubMed, Clin Res Cardiol) - P4 | "BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents."

Journal • Cardiovascular • Transplantation

The COBRA II (COmplex Bifurcation lesions: RAndomized comparison of a fully bioresorbable modified-T stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds) study: Final 5-year follow-up. (PubMed, Indian Heart J) - "In this small RCT bifurcation study, BVS luminal dimensions were significantly smaller at 30 months, with acute strut discontinuities and late Intraluminal dismantling frequently observed, although acceptable clinical outcomes were noted at 5 years."

Combination therapy • Journal • Cardiovascular • Hematological Disorders • Thrombosis

Five-Year Clinical Outcomes After Coronary Bioresorbable Scaffolds and Drug-Eluting Stents: The ABSORB IV Randomized Trial. (PubMed, J Am Coll Cardiol) - "In this large-scale, blinded randomized trial, despite improved implantation technique the absolute 5-year rate of TLF was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was restricted to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices."

Clinical data • Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Thrombosis

Long-Term Results of a Prospective, Single-Arm Evaluation of Everolimus-Eluting Bioresorbable Vascular Scaffolds in Infrapopliteal Arteries (NCVH 2023) - No abstract available

Clinical

Bioresorbable Vascular Scaffolds: A Disappearing Technology, But Should We Let It Vanish? (PubMed, J Invasive Cardiol) - "Absorb bioresorbable vascular scaffolds were designed to overcome the limitations imposed by drug-eluting stents; however, the Absorb BVS showed a 2% very late thrombosis rate...This case acts as a proof of concept demonstrating advantages of BVS, namely, the ability to image the target vessel non-invasively and revascularize percutaneously or surgically if required. We advocate continued research and development in this technology given the attractive advantages, particularly in younger patients who are likely to require future coronary intervention and imaging."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model. (PubMed, Tissue Eng Regen Med) - "BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted."

Journal • Preclinical

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. (PubMed, J Korean Med Sci) - P=N/A | "With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES."

Journal • Real-world • Real-world evidence • Cardiovascular • Hematological Disorders • Thrombosis

FRANCE-ABSORB: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS (clinicaltrials.gov) - P=N/A | N=2072 | Completed | Sponsor: French Cardiology Society | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ May 2022

Trial completion • Trial completion date

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry. (PubMed, Arch Cardiovasc Dis) - "Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years."

Clinical data • Journal • Acute Coronary Syndrome • Cardiovascular • Diabetes • Hematological Disorders • Metabolic Disorders • Thrombosis

Challenges of the newer generation of Resorbable magnesium scaffolds: Lessons from failure mechanisms of the past generation. (PubMed, J Cardiol) - "A recent clinical study demonstrated that magnesium-based BRS seems to be promising with regards to the risk of scaffold thrombosis. In this review, our aim is to describe the issues that prevented Absorb BVS from achieving favorable outcomes, provide current status of existing BRS technologies and the challenges that newer generation BRSs need to overcome, and the results of clinical studies for commercially available magnesium-based BRS, which remain the only BRS actively studied in clinical practice."

Journal • Review • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Thrombosis

Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up. (PubMed, Am J Cardiol) - "Epicardial endothelium-dependent vasomotion was defined as any vasodilatation after intracoronary acetylcholine (ACh), whereas endothelium-independent vasomotion was defined as any vasodilatation after intracoronary nitroglycerine (NTG), using quantitative coronary angiography. In conclusion, complete ABSORB-BVS resorption was demonstrated at 5-year follow-up. However, this healing response was associated with endothelium-dependent vasomotor dysfunction within the BVS segment."

Journal

Absorb IV Randomized Controlled Trial (clinicaltrials.gov) - P=N/A | N=2604 | Completed | Sponsor: Abbott Medical Devices | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease

Bioresorbable stents: Is the game over? (PubMed, Int J Cardiol) - "Newer generation BRS are under development targeting the main limitations of the ABSORB BVS, mainly focusing on reducing strut thickness, improving the mechanical structure with faster resorption times, and a better crossing profile. The story of BRS is not over yet, with ongoing refinements in the quest for the ideal stent."

Journal • Review • Cardiovascular • Hematological Disorders • Inflammation • Ischemic stroke • Thrombosis

Long-Term Results of a Prospective, Single-Arm Evaluation of Everolimus-Eluting Bioresorbable Vascular Scaffolds in Infrapopliteal Arteries (NCVH 2022) - No abstract available

Clinical

Efficacy and Safety of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Peripheral Artery Disease: A Single-Arm Meta-Analysis. (PubMed, J Endovasc Ther) - "The Absorb everolimus-eluting BVS was safe and showed the favorable clinical outcomes in both patency and TLR, especially in infrapopliteal disease with heavy calcification. The conclusions of this meta-analysis still needed to be verified by more relevant studies with more careful design, more rigorous execution, and larger sample size."

Journal • Retrospective data • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Nephrology • Peripheral Arterial Disease • Renal Disease

GABI-R: Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold (clinicaltrials.gov) - P=N/A | N=3330 | Completed | Sponsor: IHF GmbH - Institut für Herzinfarktforschung | Active, not recruiting ➔ Completed | Trial completion date: Oct 2021 ➔ Jul 2021

Trial completion • Trial completion date • Cardiovascular

Coronary artery perforation after bioresorbable scaffold implantation treated with a new generation covered stent-OCT insights. (PubMed, BMC Cardiovasc Disord) - "The utility of bioresorbable scaffold technology remains controversial although meticulous implantation techniques are associated with improved clinical outcomes. Adoption of the Pre-dilatation, Sizing and Post-dilatation ('PSP') method of BVS implantation with routine aggressive vessel preparation and scaffold optimization however may contribute to a higher risk of vessel perforation. The case emphasises the importance of accurate sizing of the vessel with intracoronary imaging and demonstrates the value of newer generation covered stents with single-layer design and slimmer crossing profile producing improved deliverability and procedural success."

Journal • Cardiovascular

Very long-term follow-up of patients with coronary bifurcation lesions treated with bioresorbable scaffolds. (PubMed, Kardiol Pol) - "Stenting of coronary bifurcation lesions of low-to moderate complexity with BVS was feasible with good acute performance and acceptable results. However, the risk of death and major adverse cardiovascular events was higher as compared with DES."

Journal • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

Long-Term Intracoronary Structural and Vasomotor Assessment of the ABSORB Bioresorbable Vascular Scaffold. (PubMed, Am J Cardiol) - "Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction."

Journal • Acute Coronary Syndrome • Cardiovascular • Fibrosis • Hypertension