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    Interventional procedure overview of bioresorbable stent implantation to treat coronary artery disease

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    Existing assessments of this procedure

    2018 European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines on myocardial revascularisation does not recommend BVS for use in clinical practice outside of clinical studies (class III recommendation, level of evidence C).

    Section 16.1.3 on bioresorbable scaffolds in the guideline states that 'bioresorbable scaffolds (BRS), which degrade to predominantly inert end products after fulfilling their scaffold function in the lesion site of the coronary vessel, have been developed with the goal of reducing or eliminating stent-related adverse events at long-term follow-up. Current scaffold platforms to have reached clinical testing are based on two different technologies: bioresorbable, polymer-based scaffolds (resorption up to 3–4 years) and resorbable, metallic (magnesium) scaffolds (resorption up to 1 year). Although a number of devices have received approval for use in Europe, randomized trial data are available only with the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular)'.

    'The safety and efficacy profile of the Absorb BVS has been compared with contemporary DES in several trials. Findings of these trials as well as meta-analyses consistently indicate the inferior efficacy and safety of Absorb BVS compared with contemporary DES during long-term follow-up. Specifically, the Absorb BVS is associated with a significantly increased risk of target lesion revascularization and device thrombosis, with numbers needed to harm of 40–60. Of note, commercial use of the Absorb BVS was stopped in 2017'.

    'Available evidence on the magnesium scaffold is limited to small observational studies. Initial results appear encouraging, but further evaluation is needed. Therefore, the Task Force endorses the recommendation of the recent ESC/European Association for Percutaneous Cardiovascular Interventions (EAPCI) document on bioresorbable scaffolds (Byrne RA 2018) that any BRS should not be used outside well-controlled clinical studies. In patients who have been treated with BRS, prolonged-duration DAPT for 3 years or longer may be considered' (Neumann FJ 2019).

    A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for bioresorbable scaffolds (BRS). It concluded that:

    • Five BRS have CE-mark approval for use in Europe, and only one device (the Absorb bioresorbable vascular scaffold) has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2–3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice.

    • On-going trials should be closely monitored for adverse events and data should be made available at regular intervals in the public domain, irrespective of the initial analysis plan.

    • It is not recommended to use BRS in patients who cannot tolerate or are unlikely to be compliant with extended duration DAPT or who require oral anticoagulants. (Byrne RA 2018).