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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, J. Eduardo Sousa, MD, PhD^_*

^_* Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Montreal Heart Institute, Montreal, Quebec, Canada

^_* Reprint requests and correspondence: Dr. Alexandre Abizaid, Instituto Dante Pazzanese De Cardiologia, Av. Dr. Dante Pazzanese, 500 Ibirapuera, São Paulo-SP, Brazil 04012-909 (Email: aabizaid{at}uol.com.br).

Objectives: We sought to investigate the performance and efficacy of the third-generation polymer-free Vestasync-eluting stent (VES).

Background: Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 µm).

Methods: In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and 14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up.

Results: Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 ± 0.32 mm and 9.98 ± 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 ± 0.25 mm and percent of stent obstruction was 2.8 ± 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered.

Conclusions: The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

Key Words: drug-eluting stents • Vestasync • hydroxyapatite

Abbreviations and Acronyms   CK = creatine kinase   CK-MB = creatine kinase-myocardial band   DES = drug-eluting stent   IVUS = intravascular ultrasound   QCA = quantitative coronary angiography   VES = Vestasync-eluting stent

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