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J Am Coll Cardiol Intv, 2008; 1:545-551, doi:10.1016/j.jcin.2008.07.003
© 2008 by the American College of Cardiology Foundation
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Preliminary Results of the Hydroxyapatite Nonpolymer-Based Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions

A First-in-Human Analysis of a Third-Generation Drug-Eluting Stent System

J. Ribamar Costa, Jr, MD*, Alexandre Abizaid, MD, PhD*,*, Ricardo Costa, MD*, Fausto Feres, MD, PhD*, Luís Fernando Tanajura, MD, PhD*, Andréa Abizaid, MD, PhD*, Luiz Alberto Mattos, MD, PhD*, Rodolfo Staico, MD*, Dimytri Siqueira, MD*, Amanda G.M.R. Sousa, MD, PhD*, Raoul Bonan, MD{dagger}, J. Eduardo Sousa, MD, PhD*

* Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
{dagger} Montreal Heart Institute, Montreal, Quebec, Canada


Figure 1
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Figure 1 Main Components of the Vestasync Sirolimus-Eluting Stent System

Scanning electron micrographs of (A) microporous hydroxyapatite coating, (B) cross section of the hydroxyapatite coating, (C) final coating, including the hydroxyapatite filled with sirolimus formulation, and (D) cross section of the final coating.

 

Figure 2
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Figure 2 Examples From Our Initial Experience

Two examples of our first-in-human series of patients treated with the Vestasync stent. Panel A demonstrates the case with higher late lumen loss at 4 months (0.80 mm). Panel B demonstrates our best results (late lumen loss of –0.1 mm). FU = follow-up; POST = post-procedure; PRE = pre-procedure.

 

Figure 3
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Figure 3 Late Lumen Loss of Vestasync Stent Versus the FDA-Approved DES

Late loss results reported for the Food and Drug Administration (FDA)–approved drug-eluting stent (DES) in contrast to the findings of the current analysis. When compared to the published results of other DES tested in similar scenarios, the in-stent late loss of the Vestasync stent is equivalent to that of the Endeavor and Taxus stents and slightly higher than that of the Cypher and Xience/Promus stents. *Invasive follow-up done at 4 months. **Invasive follow-up done at 6 months. FIM = first-in-man; SPIRIT = Stroke Prevention in Reversible Ischemia Trial.

 




 
   
 
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