Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.
OBJECTIVE
To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.


METHODS
This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.


RESULTS
After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.


CONCLUSIONS
The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.
Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, SP, Brazil.
Pedro A
PA
Lemos
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil.
Alexandre A C
AA
Abizaid
Hospital do Servidor Público Estadual - IAMSPE, São Paulo, SP, Brazil.
George C
GC
Meireles
Institute of Cardiology/Fundação Universitária de Cardiologia de Porto Alegre, Porto Alegre, RS, Brazil.
Rogério
R
Sarmento-Leite
Hospital Encore, Aparecida de Goiania, GO, Brazil.
Mauricio
M
Prudente
Hospital Bandeirantes, São Paulo, SP, Brazil.
Marcelo
M
Cantarelli
Hospital Santa Izabel, Salvador, BA, Brazil.
Adriano D
AD
Dourado
Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, SP, Brazil.
Jose
J
Mariani
Hospital Santa Marcelina, Sao Paulo, SP, Brazil.
Marco A
MA
Perin
Hospital Cardiológico Costantini, Curitiba, PR, Brazil.
Costantino
C
Costantini
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil.
Ricardo A
RA
Costa
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil.
José Ribamar
JR
Costa
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil.
Daniel
D
Chamie
Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, SP, Brazil.
Carlos A
CA
Campos
Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, SP, Brazil.
Expedito
E
Ribeiro
D020341:Absorbable Implants; D000368:Aged; D001938:Brazil; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; C518022:umirolimus; D020123:Sirolimus
Atherosclerosis; Coronary; Drug-eluting stents; Stent