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

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    Additional information considered by IPAC

    Professional experts' opinions

    Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate. 2 professional expert questionnaires for bioresorbable stent implantation for treating coronary artery disease were submitted and can be found on the NICE website.

    Patient organisation opinions

    Patient organisation submissions for bioresorbable stent implantation for treating coronary artery disease were not received.

    Patient commentators' opinions

    NICE's Public Involvement Programme sent questionnaires to NHS trusts for distribution to patients who had the procedure (or their carers). When NICE has received the completed questionnaires, these will be discussed by the committee.

    Company engagement

    A structured information request was sent to 4 companies who manufacture a potentially relevant device for use in this procedure. NICE received 1 completed submission. This was considered by the IP team and any relevant points have been taken into consideration when preparing this overview.

    Issues for consideration by IPAC

    • Ongoing studies

    NCT02601781: A prospective evaluation of a standardised strategy for the use of bioresorbable vascular scaffold in ST-segment elevation myocardial infarction: the BVS STEMI STRATEGY-IT registry. Procedure: primary percutaneous coronary intervention (PPCI); Device (BVS ABSORB); single group assignment; n=500, primary outcome: device oriented composite end-point (DOCE) at 30 days; location: Italy; start date October 2015, completion date December 2021.

     NCT03112707: Performance of bioresorbable polymer-coated everolimus-eluting synergy® stent in patients at high bleeding risk having percutaneous coronary revascularisation followed by 1-month dual antiplatelet therapy. Single group assignment; n=1023 patients, primary outcome: MACE rate 1 year; location: Italy; start date April 2017, completion date May 2020.

    NCT01761578: First in man safety evaluation of the ART18Z bioresorbable stent for the treatment of single de novo lesion of a native coronary artery. Device: ART18Z bioresorbable stent; n=30; single group assignment; primary outcome: MACE rate at 6 months; location: France; start date June 2012, study completion date not available.

    NCT02067091: Performance of bioresorbable scaffold in primary percutaneous intervention of ST Elevation Myocardial Infarct (BVS in STEMI). Randomised clinical trial; n=120; Absorb BVS versus DES; primary outcome: coronary stent healing index at 12 months; location Denmark, Norway; start date August 2014, study completion date August 2020.

    • First-generation Absorb BVS is the only device that has FDA approval but has been withdrawn from the market since September 2017.However,long-term follow-up associated with this device have been published. A second-generation Absorb BVS and other new polymer-or magnesium based scaffolds (with thinner strut profiles, advanced mechanical properties and faster reabsorption) are under development.

    • Following current ESC guidelines, Magmaris BVS has only been used in clinical trials in the UK (BIOSOLVE VI).

    References

    1. IAMEV, SNSPMPDSB et al. Bioresorbable stents for the treatment of cardiovascular indications (coronary artery disease). Rapid assessment of other health technologies using the HTA Core Model for Rapid Relative Effectiveness Assessment. EUnetHTA Project ID: OTCA16. 2019.

    2. Ni L, Chen H, Luo Z et al. (2020) Bioresorbable vascular stents and drug-eluting stents in treatment of coronary heart disease: a meta-analysis. Journal of Cardiothoracic Surgery. 15:26, 1-7.

    3. Stone GW, Kimura T, Gao R et al. (2019) Time varying outcomes with the Absorb bioresorbable vascular scaffold during 5-year follow-up. A systematic meta-analysis and individual patient data pooled study. JAMA Cardiology; 4 (12): 1261-1269.

    4. Kang S-H, Gogas BD, Jeon K-H et al. (2018) Long-term safety of bioresorbable scaffolds: insights from a network meta-analysis including 91 trials. EuroIntervention;13:1904-1913.

    5. Baumbach A, Zaman A, West NEJ et al. (2018) Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry. EuroIntervention;13:1554-1560.

    6. Cakal S, Cakal B, Karaca O et al. (2021) Long-term outcomes of Absorb bioresorbable vascular scaffold using predilation, sizing, and postdilation protocol in a real-world patient population. Turk Kardiyol Dern Ars; 49(1):40-50.

    7. Costa JR, Abizaid A, Whitbourn R et al. (2019) Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv, 93 (1), pp.E1-E7. https://doi.org/10.1002/ccd.27715.

    8. Wiebe J, Hoppmann P, Cassese S et al. (2021) Outcomes after complete dissolution of everolimus-eluting bioresorbable scaffolds implanted during routine practice. Rev Esp Cardiol. 74(7):584–590.

    9. Sabate M, Alfonso F, Cequier A et al. (2019) Magnesium-based resorbable scaffold versus permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction the MAGSTEMI randomized clinical trial. Circulation.140:1904–1916.

    10. Haude M, Ince H, Kische S et al. (2020) Sustained safety and performance of the second-generation sirolimus-eluting absorbable metal scaffold: pooled outcomes of the BIOSOLVE-II and -III trials at 3 years. Cardiovascular Revascularization Medicine 21, 1150–1154.

    11. Chua SK and Cheng JJ (2017) Coronary artery aneurysm after implantation of a bioresorbable vascular scaffold: case report and literature review. Catheterization and Cardiovascular Interventions 90:E41–E45.

    12. Schinke K, Langwieser N, Laugwitz KL et al. (2015) A potential life-threatening complication after implantation of a bioresorbable scaffold for coronary stenting within a mechanically stressed region. Clin Res Cardiol (2015) 104:366–367.

    13. Neumann FJ, Saousa-Uva M, Ahlsson A et al. (2019) 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 40 (2):87 –165.

    Sousa-Uva M, Neumann F-J, Ahlsson A, Alfonso F, Banning AP, Benedetto U et al. (2019) 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg; 55:4–90.

    1. Byrne RA, Stefanini GG, Capodanno D, et al. Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. EuroIntervention. 2018;13:1574–1586.