Elsevier

The Lancet

Volume 387, Issue 10018, 6–12 February 2016, Pages 537-544
The Lancet

Articles
Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials

https://doi.org/10.1016/S0140-6736(15)00979-4Get rights and content

Summary

Background

Bioresorbable coronary stents might improve outcomes of patients treated with percutaneous coronary interventions. The everolimus-eluting bioresorbable vascular scaffold is the most studied of these stent platforms; however, its performance versus everolimus-eluting metallic stents remains poorly defined. We aimed to assess 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.

Methods

We searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites for randomised trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was target lesion revascularisation and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischaemia-driven target lesion revascularisation), myocardial infarction, death, and in-device late lumen loss. We derived odds ratios (ORs) and weighted mean differences with 95% CIs, and calculated the risk estimates for the main outcomes according to a random-effects model. This study is registered with PROSPERO, number CRD42015026374.

Findings

We included six trials, comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or an everolimus-eluting metallic stent (n=1401). Median follow-up was 12 months (IQR 9–12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularisation (OR 0·97 [95% CI 0·66–1·43]; p=0·87), target lesion failure (1·20 [0·90–1·60]; p=0·21), myocardial infarction (1·36 [0·98–1·89]; p=0·06), and death (0·95 [0·45–2·00]; p=0·89) as those treated with metallic stents. Patients treated with a bioresorbable vascular scaffold had a higher risk of definite or probable stent thrombosis than those treated with a metallic stent (OR 1·99 [95% CI 1·00–3·98]; p=0·05), with the highest risk between 1 and 30 days after implantation (3·11 [1·24–7·82]; p=0·02). Lesions treated with a bioresorbable vascular scaffold had greater in-device late lumen loss than those treated with a metallic stent (weighted mean difference 0·08 [95% CI 0·05–0·12]; p<0·0001).

Interpretation

Compared with everolimus-eluting metallic stents, everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularisation at 1 year of follow-up, despite inferior mid-term angiographic performance. However, patients treated with a bioresorbable vascular scaffold had an increased risk of subacute stent thrombosis. Studies with extended follow-up in a larger number of patients are needed to fully assess the long-term advantages of everolimus-eluting bioresorbable vascular scaffolds.

Funding

None.

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

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