EXCELLA First-in-Man (FIM) study: safety and efficacy of novolimus-eluting stent in de novo coronary lesions.
OBJECTIVE
First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS.


RESULTS
In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up.


CONCLUSIONS
In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.
Costa
J Ribamar
JR
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Abizaid
Alexandre
A
Feres
Fausto
F
Costa
Ricardo
R
Seixas
Ana Cristina
AC
Maia
Felipe
F
Abizaid
Andrea
A
Tanajura
Luis Fernando
LF
Staico
Rodolfo
R
Siqueira
Dimytri
D
Meredith
Lynn
L
Bhat
Vinayak
V
Yan
John
J
Ormiston
John
J
Sousa
Amanda G M R
AG
Fitzgerald
Peter
P
Sousa
J Eduardo
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018942:Macrolides / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D000903:Antibiotics, Antineoplastic; D002858:Chromium Alloys; D018942:Macrolides; C534800:novolimus; D020123:Sirolimus