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1-Year Results of the Hydroxyapatite Polymer-Free Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions

The VESTASYNC I Trial

J. Ribamar Costa, Jr, MD^_*, Alexandre Abizaid, MD, PhD^_*,_*, Ricardo Costa, MD^_*, Fausto Feres, MD, PhD^_*, Luiz Fernando Tanajura, MD, PhD^_*, Andréa Abizaid, MD, PhD^_*, Galo Maldonado, MD^_*, 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, Quebec, Canada

^_* Reprint requests and correspondence: Dr. Alexandre Abizaid, Av. Dr Dante Pazzanese, 500. Ibirapuera. São Paulo-SP, Brazil 04012-180 (Email: aabizaid{at}uol.com.br).

Objectives: We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 µg).

Background: Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.

Methods: A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and 14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.

Results: Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 ± 0.3 mm and 10 ± 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 ± 0.25 mm and 2.6 ± 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 ± 0.23 mm and 4.0 ± 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.

Conclusions: The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.

Key Words: polymer-free sirolimus eluting stent • intravascular ultrasound • quantitative coronary angiography

Abbreviations and Acronyms   DES = drug-eluting stent(s)   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MLD = minimum lumen diameter   QCA = quantitative coronary angiography

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