Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial.
OBJECTIVE
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.


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.
Onuma
Yosinobu
Y
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
Serruys
Patrick W
PW
Ormiston
John A
JA
Regar
Evelyn
E
Webster
Mark
M
Thuesen
Leif
L
Dudek
Dariusz
D
Veldhof
Susan
S
Rapoza
Richard
R
D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus