First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries).
JACC Cardiovasc Interv
; 6(10): 1026-34, 2013 Oct.
Article
em En
| MEDLINE
| ID: mdl-24055443
ABSTRACT
OBJECTIVES:
This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.BACKGROUND:
Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.METHODS:
We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up.RESULTS:
The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction.CONCLUSIONS:
At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428).Palavras-chave
AP; APSES; BMS; CI; DAPT; DES; ISA; IVUS; LLL; MACE; MI; MLD; OCT; QCA; SES; ST; TLR; TVR; absorbable polymer; absorbable polymer(s); absorbable polymer-coated, sirolimus-eluting stent(s); bare-metal stent(s); confidence interval; coronary artery disease; coronary stent(s); drug-eluting stent(s); dual antiplatelet therapy; incomplete stent apposition; intravascular ultrasound; late lumen loss; major adverse cardiac event(s); minimal lumen diameter; myocardial infarction; optical coherence tomography; percutaneous coronary intervention; quantitative coronary angiography; sirolimus-eluting stent; sirolimus-eluting stent(s); stent thrombosis; target lesion revascularization; target vessel revascularization
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Polímeros
/
Doença da Artéria Coronariana
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Fármacos Cardiovasculares
/
Sirolimo
/
Implantes Absorvíveis
/
Estenose Coronária
/
Stents Farmacológicos
/
Intervenção Coronária Percutânea
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Aged80
País/Região como assunto:
Europa
/
Oceania
Idioma:
En
Revista:
JACC Cardiovasc Interv
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2013
Tipo de documento:
Article