A randomised comparison between everolimus-eluting stent and sirolimus-eluting stent in chronic coronary total occlusions. Rationale and design of the CIBELES (non-acute Coronary occlusion treated by EveroLimus-Eluting Stent) trial.
Chronic total coronary occlusions constitute a sub-group of lesions at very high risk of restenosis after successful percutaneous coronary intervention. The sirolimus-eluting coronary stent is the only drugeluting stent that has demonstrated to reduce angiographic restenosis and the need for new revascularisation procedures in comparison with bare-metal stents in randomised clinical trials focusing on these lesions. Everolimus-eluting stents have shown to offer optimal angiographic and clinical outcomes in comparison with bare-metal stents and paclitaxel-eluting stents, but no randomised trials have tested the device in chronic total occlusions. The CIBELES (non-acute Coronary occlusIon treated By EveroLimus- Eluting Stent) will randomise 208 patients with chronic total coronary occlusions in 13 centres from Portugal and Spain to receive everolimus- or sirolimus-eluting coronary stents. The primary endpoint will be angiographic in-stent late loss.
Moreno
Raúl
R
University Hospital La Paz, Madrid, Spain. raulmorenog@terra.es
Garcia
Eulogio
E
Teles
Rui C
RC
Almeida
Manuel S
MS
Carvalho
Henrique Cyrne
HC
Sabate
Manel
M
Martin-Reyes
Roberto
R
Rumoroso
José Ramón
JR
Galeote
Guillermo
G
Goicolea
Francisco Javier
FJ
Moreu
José
J
Mainar
Vicente
V
Mauri
Josefa
J
Ferreira
Rui
R
Valdes
Mariano
M
Perez de Prado
Armando
A
Martin-Yuste
Victoria
V
Jimenez-Valero
Santiago
S
Sanchez-Recalde
Angel
A
Calvo
Luis
L
Lopez de Sa
Esteban
E
Macaya
Carlos
C
Lopez-Sendon
Jose-Luis
JL
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D011174:Portugal; D011474:Prosthesis Design; D012107:Research Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus