Clinical trial NCT00793221: Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent
Official title: Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Occlusion
Percutaneous Coronary Intervention
Keywords: Coronary stent.
Restenosis.
Coronary artery disease.
Chronic total occlusion.
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demonstrated to significantly reduce the risk of restenosis and new revascularization procedures in comparison with bare-metal stents.

Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher stent is the only DES that has been randomly tested in CTO. Among second-generation DES, everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but this DES has not been studied in unfavourable scenario (such as CTO).

The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic efficacy considered as in-stent late lumen loss.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 year-old.
* A total occlusion (TIMI 0-1) with an estimated time of occlusion \> 2 weeks.
* Symptomatic or silent ischaemia, or viable myocardium.
* The occlusion is suitable for percutaneous coronary intervention.
* The guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.

Exclusion Criteria:

* Acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
* The lesion can not be crossed with the guidewire and balloon angioplasty.
* The vessel has been previously treated percutaneously.
* The lesion is not suitable for a 2.25-3.5 coronary stent implantation.
* The patient is not willing to undergo an angiographic follow-up.
* The patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
* Pregnancy or absence of pregnancy test in women of childbearing age.
* Chronic renal failure (creatinine plasmatic values \> 3.0 mg/dl).
* Plasmatic platelet count \< 100.000 mm-3 or \> 700.000 mm-3.
* The patient has a severe non-cardiac disease that limits his/her life expectancy to \< 1 year.
* The patient is currently included in other randomized trial.

Primary outcomes:
measure: In-stent late lumen loss at 9-month angiographic follow-up
timeFrame: 9 months
Secondary outcomes:
measure: Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months
timeFrame: 9 and 12 months
measure: Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.
timeFrame: 9 and 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Ruiz-Garcia J, Teles R, Rumoroso JR, Cyrne Carvalho H, Goicolea FJ, Moreu J, Mauri J, Mainar V, Garcia E, Moreno R; CIBELES investigators. Comparison between diabetic and non-diabetic patients after successful percutaneous coronary intervention for chronic total occlusions in the drug-eluting stent era. Rev Port Cardiol. 2015 Apr;34(4):263-70. doi: 10.1016/j.repc.2014.10.009. Epub 2015 Apr 1.
citation: Moreno R, Garcia E, Teles R, Rumoroso JR, Cyrne Carvalho H, Goicolea FJ, Moreu J, Mauri J, Sabate M, Mainar V, Patricio L, Valdes M, Fernandez Vazquez F, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Almeida M, Lopez de Sa E, Calvo L, Plaza I, Lopez-Sendon JL, Martin JL; CIBELES Investigators. Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial. Circ Cardiovasc Interv. 2013 Feb;6(1):21-8. doi: 10.1161/CIRCINTERVENTIONS.112.000076. Epub 2013 Feb 12.
citation: Moreno R, Garcia E, Teles RC, Almeida MS, Carvalho HC, Sabate M, Martin-Reyes R, Rumoroso JR, Galeote G, Goicolea FJ, Moreu J, Mainar V, Mauri J, Ferreira R, Valdes M, Perez de Prado A, Martin-Yuste V, Jimenez-Valero S, Sanchez-Recalde A, Calvo L, Lopez de Sa E, Macaya C, Lopez-Sendon JL. 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. EuroIntervention. 2010 May;6(1):112-6.