ArticlesA 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
Introduction
The implantation of a bioresorbable scaffold is a new approach that provides transient vessel support with drug delivery capability, potentially without the limitations of permanent metallic implants.1, 2 By liberating the coronary artery from the metallic caging, the vessel recovers pulsatility and becomes responsive to shear stress and physiological cyclic strain.3, 4, 5 The vessel wall, theoretically, can remodel and exhibit plaque reduction in response to pharmacological treatment and physiological stimuli. The potential of this technology has been shown in some studies with up to 3-year follow-up with several imaging modalities.6, 7, 8, 9, 10, 11
The use of bioresorbable scaffolds has several challenges that justify careful assessment of this technology. First, the mechanical property of the polymeric scaffold should match that of metallic stents; the acute recoil of the scaffold has previously been reported to be similar to that noted with an equivalent device in metal.12 The mechanical integrity and the absence of recoil has to be maintained for 6 months, during which time the biological process of restenosis (consisting of neointimal formation and constrictive remodelling) fully subsides, therefore not justifying a permanent prosthesis beyond this time.13 The second challenge to be taken into consideration is that the bioresorption of the polymeric scaffold should not trigger an inflammatory reaction that could result in late renarrowing of the vessel. Over time, the polymer is replaced by a provisional matrix made of proteoglycan that evolves into de-novo connective tissue.14 Eventual late enlargement of the scaffold and lumen has been documented at 2–3 years, compensating for the intraluminal growth of the neointima.15
In a randomised, single-blind, active-controlled trial (the ABSORB II study), we aimed to compare a bioresorbable everolimus-eluting scaffold with a metallic everolimus-eluting stent to treat ischaemic heart disease. Because the bioresorbable scaffold has been commercially available since August, 2012, and has been widely and rapidly disseminated in the absence of comparative data from randomised trials, the steering committee and trial funder decided to report secondary clinical and procedural endpoints at 1 year. Hence, we report secondary endpoints for clinical, procedural, anginal, and disease-related quality-of-life outcomes.
Section snippets
Study design and participants
The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. Eligible participants were aged 18–85 years with evidence of myocardial ischaemia, were suitable for coronary artery bypass graft surgery, and had one or two de-novo native lesions in different epicardial vessels. Patients with acute myocardial infarction before the procedure without normalised cardiac enzymes, evidence of ongoing acute myocardial infarction before
Results
Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients from 46 sites in Europe and New Zealand, and randomly assigned them to the bioresorbable scaffold group (335 patients) or the metallic stent group (166 patients; figure 1).
Table 1 shows patient demographics, risk factors, and use of antianginal drugs and antiplatelet therapy at baseline. The prevalence of diabetes was 24%, with more than a quarter of these patients being insulin dependent. Roughly 20% of patients presented with
Discussion
The main findings of this interim report of secondary outcomes and post-hoc analysis of 1-year follow-up data are that the device success rate of the bioresorbable scaffold matched that of the metallic stent; acute recoil of both devices were similar; the procedural lumen gain was slightly less with the bioresorbable scaffold than with the metallic stent because of the use of smaller balloons at lower pressure for deployment and dilatation of the bioresorbable scaffold; and that functional
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2023, Bioactive MaterialsCitation Excerpt :Stone GW(2016, NEW ENGL J MED) [90], belonging to cluster #8 with the co-occurrence frequency of 135, showed that PCI with EES was non-inferior to CABG in terms of the 3-year composite endpoint incidence of death, stroke, or myocardial infarction in patients with left main stem coronary artery disease and a low or moderate SYNTAX score by site assessment. Serruys PW(2015, LANCET) [92], belonging to cluster #10 with the co-occurrence frequency of 157, secondary clinical and surgical outcomes were compared after a 1-year follow-up between everolimus-eluting bioresorbable stents and everolimus-eluting metallic stents and found that everolimus-eluting bioresorbable stents had similar 1-year composite secondary clinical outcomes as everolimus-eluting metallic stents. Von Birgelen C (2016, LANCET) [106], belonging to cluster #14 with the co-occurrence frequency of 108, demonstrated that two very thin strut DES with different biodegradable polymer coatings (eluting everolimus or sirolimus) were not inferior to the durable polymer stent (eluting zotamox) in terms of 1-year safety and efficacy in treating a high proportion of patients with acute coronary syndromes in all patients.
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