ArticlesEverolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials
Introduction
Contemporary high-performance metallic drug-eluting stents are the gold standard for percutaneous treatment of ischaemic heart disease.1 However, late adverse events related to the stented segment continue to accrue, and evidence suggests that accelerated atherosclerosis inside the stent represents an important underlying mechanism.2
In the past decade, fully bioresorbable stents eluting anti-restenotic drugs have attracted substantial interest. Indeed, these platforms offer a transient arterial support until the elution process is completed, potentially avoiding late vascular consequences due to permanent metal constraints.3 So far, two devices have received CE-mark approval: the Absorb everolimus-eluting bioresorbable scaffold (Abbott Vascular, Santa Clara, CA, USA) and the novolimus-eluting DESolve stent (Elixir Medical Corporation, Sunnyvale, CA, USA). Of these devices, the everolimus-eluting bioresorbable vascular scaffold—a balloon-expandable bioresorbable scaffold consisting of a poly-L-lactide backbone (150 μm in thickness) coated with a 1:1 mixture of poly-D,L-lactide and everolimus (8·2 μg/mm)—is the platform with the largest available preclinical and clinical evidence.3 Preclinical and imaging-based clinical findings have shown that this device has favourable healing characteristics, allows restored vasomotor function of the treated segment, and provides an increase in lumen calibre due to positive vessel remodelling once dissolved.4 However, data from routine clinical practice suggest that it is associated with a somewhat higher rate of adverse events than occur with contemporary metallic drug-eluting stents.5 In particular, rates of thrombosis after implantation of bioresorbable vascular scaffolds can be marginally greater.6
Findings from various randomised clinical trials7, 8, 9, 10, 11, 12 have shown similar mid-term outcomes between patients who receive everolimus-eluting bioresorbable vascular scaffolds and those who receive everolimus-eluting metallic stents. However, most of these trials were small and not adequately powered to assess clinical endpoints. Therefore, we undertook a meta-analysis of randomised trials investigating the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation.
Section snippets
Search strategy and selection criteria
In accordance with PRISMA guidelines,13 we searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites (www.cardiosource.com, www.clinicaltrialresults.org, www.escardio.org, www.tctmd.com, www.theheart.org) for articles published or posted between Nov 30, 2006, and Oct 12, 2015, with no restrictions on language or publication status. We checked the reference lists from all eligible studies to identify additional
Results
Figure 1 shows a flow diagram of the study selection process. We included six trials,7, 8, 9, 10, 11, 12 comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either everolimus-eluting bioresorbable vascular scaffolds (n=2337) or everolimus-eluting metallic stents (n=1401). The appendix shows the main characteristics of the trials. Patients randomised to receive a bioresorbable vascular scaffold were treated with the Absorb stent.4 Patients randomised
Discussion
To our knowledge, this is the first meta-analysis of randomised trials investigating the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation. Our findings show that bioresorbable vascular scaffolds had a similar risk of repeat revascularisation as metallic stents, a higher risk of stent (scaffold) thrombosis at 1 year of follow-up, and an inferior
References (23)
- et al.
Current status of bioresorbable scaffolds in the treatment of coronary artery disease
J Am Coll Cardiol
(2014) - et al.
Bioresorbable drug-eluting stents: an immature technology in need of mature application
JACC Cardiovasc Interv
(2015) - et al.
A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
Lancet
(2015) - et al.
Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds
J Am Coll Cardiol
(2015) - et al.
An international registry of systematic-review protocols
Lancet
(2011) - et al.
Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design
Am Heart J
(2014) - et al.
ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance
JACC Cardiovasc Interv
(2014) - et al.
2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI)
Eur Heart J
(2014) - et al.
Neoatherosclerosis: overview of histopathologic findings and implications for intravascular imaging assessment
Eur Heart J
(2015) - et al.
Bioresorbable scaffolds: rationale, current status, challenges, and future
Eur Heart J
(2014)
Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry
EuroIntervention
Cited by (320)
Comparison of acute versus stable coronary syndrome in patients treated with the Magmaris scaffold: Two-year results from the Magmaris Multicenter Italian Registry
2023, Cardiovascular Revascularization MedicinePreparation of fully bio-based multilayers composed of heparin-like carboxymethylcellulose sodium and chitosan to functionalize poly (L-lactic acid) film for cardiovascular implant applications
2023, International Journal of Biological MacromoleculesBioresorbable polymers for medical applications
2023, Handbook of Polymers in MedicineSustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry
2022, Cardiovascular Revascularization Medicine
- †
These authors contributed equally