1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial.
OBJECTIVE
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 microg).


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 <or=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.
Costa
J Ribamar
JR
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Abizaid
Alexandre
A
Costa
Ricardo
R
Feres
Fausto
F
Tanajura
Luiz Fernando
LF
Abizaid
Andréa
A
Maldonado
Galo
G
Staico
Rodolfo
R
Siqueira
Dimytri
D
Sousa
Amanda G M R
AG
Bonan
Raoul
R
Sousa
J Eduardo
JE
D015906:Angioplasty, Balloon, Coronary; D001241:Aspirin; D000077144:Clopidogrel; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000628:therapy; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D017886:Durapatite; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D014463:Ultrasonography
D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D017886:Durapatite; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus