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.
OBJECTIVE
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 mum).


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 < or =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.
Costa
J Ribamar
JR
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Abizaid
Alexandre
A
Costa
Ricardo
R
Feres
Fausto
F
Tanajura
Luís Fernando
LF
Abizaid
Andréa
A
Mattos
Luiz Alberto
LA
Staico
Rodolfo
R
Siqueira
Dimytri
D
Sousa
Amanda G M R
AG
Bonan
Raoul
R
Sousa
J Eduardo
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001241:Aspirin / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D017886:Durapatite; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D013193:Stainless Steel; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D013193:Stainless Steel; D017886:Durapatite; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus