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EXCELLA First-in-Man (FIM) study: safety and efficacy of novolimus-eluting stent in de novo coronary lesions.
- Source :
-
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology [EuroIntervention] 2008 May; Vol. 4 (1), pp. 53-8. - Publication Year :
- 2008
-
Abstract
- Aims: 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.<br />Methods and 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.<br />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.
- Subjects :
- Aged
Antibiotics, Antineoplastic adverse effects
Chromium Alloys
Coronary Angiography
Coronary Artery Disease diagnostic imaging
Feasibility Studies
Female
Follow-Up Studies
Humans
Macrolides adverse effects
Male
Middle Aged
Treatment Outcome
Ultrasonography, Interventional
Angioplasty, Balloon, Coronary
Antibiotics, Antineoplastic administration & dosage
Coronary Artery Disease therapy
Drug-Eluting Stents adverse effects
Macrolides administration & dosage
Sirolimus analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1774-024X
- Volume :
- 4
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 19112779
- Full Text :
- https://doi.org/10.4244/eijv4i1a10