Key result
A fully resorbable everolimus-eluting scaffold demonstrated a sustained low ischaemia-driven major adverse cardiac event rate of 3.4% at 3 years without any late stent thrombosis.
Why the study?
Does a fully resorbable everolimus-eluting scaffold prevent ID-MACE in patients with a single de novo native coronary artery lesion?
Does a fully resorbable everolimus-eluting scaffold prevent ID-MACE in patients with a single de novo native coronary artery lesion?
Three-year clinical follow-up of the first-in-man trial of a bioresorbable everolimus-eluting scaffold showed a sustained low MACE rate of 3.4% without late complications such as stent thrombosis.
Supports further scaffold development in de novo lesions; leaves open need for randomized confirmation before practice change.
AIMS: Multimodality imaging of the first-in-man trial using a fully resorbable everolimus-eluting scaffold (BVS, Abbott Vascular, Santa Clara, CA, USA) demonstrated at two years the bioresorption of the device while preventing restenosis. Nevertheless, the long-term safety and efficacy of this novel therapy remain to be documented. METHODS AND RESULTS: The ABSORB trial completed in July 2006 at four clinical sites in Europe and New Zealand the enrolment of 30 patients with a single de novo native coronary artery lesion. The major clinical endpoint was ischaemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularisation. Clinical follow-up was available in 29 patients since one patient withdrew consent. At 46 days, one patient experienced a single episode of chest pain and underwent a diagnostic optical coherence tomography and subsequently a target lesion revascularisation with slight troponin rise after the procedure. At 3-year the hierarchical ID-MACE of 3.4% remained unchanged. Clopidogrel therapy was discontinued in all but one patient. There has been no stent thrombosis reported. Two non-cardiac deaths were reported; one from duodenal perforation, the other from Hodgkin disease. Two patients underwent non-ischaemia driven target vessel revascularisation. CONCLUSIONS: Three-year clinical results have demonstrated a sustained low MACE rate (3.4%) without any late complication such as stent thrombosis.
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Onuma et al. (2010) studied de novo coronary artery disease (n=30). Bioresorbable everolimus-eluting scaffold (BVS) was evaluated on Ischaemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularisation. A fully resorbable everolimus-eluting scaffold demonstrated a sustained low ischaemia-driven major adverse cardiac event rate of 3.4% at 3 years without any late stent thrombosis.
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