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Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial.
- Source :
-
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2014 Dec 01; Vol. 84 (7), pp. 1073-9. Date of Electronic Publication: 2014 Aug 22. - Publication Year :
- 2014
-
Abstract
- Aim: We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 μg).<br />Methods: The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients.<br />Results: Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%).<br />Conclusion: The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.<br /> (© 2013 Wiley Periodicals, Inc.)
- Subjects :
- Coronary Artery Disease diagnostic imaging
Double-Blind Method
Drug-Eluting Stents
Electrocardiography
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
Treatment Outcome
Coated Materials, Biocompatible
Coronary Angiography methods
Coronary Artery Disease surgery
Percutaneous Coronary Intervention methods
Stents
Ultrasonography, Interventional methods
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 84
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 23460415
- Full Text :
- https://doi.org/10.1002/ccd.24909