The project was executed by the Institute for General Practice and Evidence-based Health Service Research (IAMEV), Medical University of Graz (Austria) and National School of Public Health, Management and Professional Development Bucharest (SNSPMPDSB), Romania. The dedicated reviewers come from the French High Authority for Health (HAS) and Health Service of Canary Islands (SESCS), and the whole project was managed by the Austria Ludwig-Boltzmann institute.
Fully bioresorbable stents or scaffolds (BRS) represent the latest generation of devices for myocardial revascularization strategies. These could be either drug-coated or drug-free. They are mainly built to overcome the risk of late complications, such as scaffold thrombosis or restenosis, which can occur when the rigid metal backbone of a conventional metal stent remains permanently embedded in the diseased vessel. To date, five devices (Absorb® , DESolve® , ART Pure, Fantom®, and Magmaris) have received Conformité Européenne (CE) marking for their use in adult patients with coronary artery disease (CAD). The two main options currently available for revascularization in patients with CAD are percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG).
The HTA Core Model Application for Rapid Relative Effectiveness Assessments (REA, v 4.2) was followed for the selection of assessment elements. This assessment was based on a systematic review of the same topic authored by the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) in 2015. To identify primary studies for effectiveness and safety, a systematic literature search was conducted on the 10th of September 2018 in databases such as Medline, PubMed, Embase, and various Cochrane websites. Furthermore, a search for relevant ongoing studies was carried out of the clinical trial registries ClinicalTrials.gov and World Health Organisation (WHO)-International Clinical Trials Registry Platform (ICTRP).
Results - effectiveness
Eight relevant RCTs (n=5683), reported in 18 publications, were identified. In 7 of those, an everolimus-eluting permanent metal stent (Xience® or Synergy®) was the comparator device. All studies assessed the everolimus-eluting BRS Absorb®. No RCTs investigating one of the other CE-certificated fully BRS (DESolve® , Magmaris, ART Pure or Fantom®)
- What is the expected beneficial effect of fully BRS on mortality?
- A meta-analysis including results from the maximum length of follow-up in RCTs showed no significant difference between Absorb® BVS and permanent metal drug-eluting stents (DES) [RR 0.84 (95% CI 0.63– 1.11); p=0.22; 0% heterogeneity]
- How does fully BRS affect symptoms and findings (severity and frequency) of CAD?
- The meta-analysis for the maximum length of follow-up showed statistically significant higher rates of MIs for patients treated with Absorb® BVS compared with patients treated with permanent metal DES [RR 1.49 (95% CI 1.21– 1.84); p=0.0002; 0% heterogeneity]
- What is the effect of fully BRS on patients’ body functions?
- No evidence was identified to answer the research question ‘patients’ body functions’ for the fully BRS
- How does the use of fully BRS affect activities of daily living?
- There was no significant difference between patients in the Absorb® BVS group and patients in the DES group
- What is the effect of fully BRS on generic health-related quality of life?
- No evidence was identified in any of the trials to answer the research question on generic health-related quality of life
- What is the effect of fully BRS on disease-specific quality of life?
- No difference between the Absorb® BVS and DES was identified
Results - safety
In addition to the RCTs, 45 prospective single-arm studies (observational studies and registries; n>15,000) were considered.
- How safe is BRS in relation to the comparators?
- The meta-analysis showed no statistical difference between Absorb® BVS and permanent metal DES [RR 1.22 (95% CI 0.82–1.82); p=0.32; 0% heterogeneity]
- However, the meta-analysis resulted in a statistically significant higher risk for very late scaffold thrombosis in patients treated with the Absorb® BVS [RR 5.09 (95% CI 1.97–13.17); p=0.0008; 0% heterogeneity]
- How does the frequency or severity of harm change over time or in different settings?
- No evidence identified in the RCTs
- No association could be found between the rate of bleeding as a result of antiplatelet therapy or the rate of death as a result of bleeding or stroke and the length of follow-up in prospective uncontrolled studies
- What are the susceptible patient groups that are more likely to be harmed through the use of fully BRS?
- No difference was found regarding the rates of safety events
- What kind of data/records and/or registry is needed to monitor the use of BVS and the comparators?
- No evidence was identified to answer this question.
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