Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: The ABSORB trial
EuroIntervention , Volume 6 - Issue 4 p. 447- 453
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.
|Organisation||Erasmus MC: University Medical Center Rotterdam|
Onuma, Y, Serruys, P.W.J.C, Ormiston, J.A, Regar, E.S, Webster, M, Thuesen, L, … Rapoza, R. (2010). Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: The ABSORB trial. EuroIntervention, 6(4), 447–453. Retrieved from http://hdl.handle.net/1765/82824