CIBELES: Xience Stands Up to Cypher for CTO PCI

PARIS, France—A second-generation drug-eluting stent that releases everolimus performs just as well in treating chronic total occlusions (CTOs) as its sirolimus-eluting predecessor, according to findings presented Thursday, May 17, at EuroPCR 2012.

Raul Moreno, MD, of University Hospital La Paz (Madrid, Spain), shared results of the CIBELES trial, which enrolled 207 patients whose total coronary occlusions had been present at least 2 weeks, with approximately 80% having CTO lesions present 3 months or longer. Patients were randomized to receive a Cypher sirolimus-eluting stent (SES; n = 101; Cordis, Miami Lakes, FL) or Xience V everolimus-eluting stent (EES; n = 106; Abbott Vascular, Abbott, IL). Baseline characteristics were similar between the 2 groups.

In the 181 patients with angiographic follow-up available at 9 months, in-stent late loss (primary endpoint) was similar at 0.13 ± 0.69 with EES and 0.29 ± 0.60 mm with SES (P = 0.116). This fell within the prespecified margin for noninferiority of 0.20 mm. Binary restenosis  rates also were equivalent (9.1% EES vs. 10.5% SES; P = 0.709), as were reocclusion rates (1% EES vs. 3.2% SES; P = 0.339).

By 1 year, clinical outcomes were numerically higher with SES but statistically similar for the 2 stent designs. All deaths were cardiac. Stent thrombosis was only observed in the SES group, with events occurring in 3 patients: at 24 hours, 9 days, and 117 days (table 1).

Table 1. CIBELES: Adverse Events at 1 Year


(n = 101)

(n = 106)







Acute MI






Definite/Probable Stent Thrombosisa



Log-rank P value = 0.075.

So far, SES are the only DES to have been tested in large randomized trials against BMS for CTO lesions, Dr. Moreno reported. “Because of that, according to evidence-based medicine, the drug-eluting stent of choice in these patients should be [Cypher],” he said. However, Xience offers a better platform, low in-stent late loss, and a “very good safety profile,” Dr. Moreno added. “But no randomized trials have been performed evaluating the everolimus-eluting stent in these patients.”

CIBELES indicates that EES are noninferior to SES for CTO PCI, he concluded.

Session co-moderator Spencer B. King III, MD, of Saint Joseph's Heart and Vascular Institute (Atlanta, GA), asked for clarification as to whether the study was blinded.

“Physicians performing angiographic follow-up know the type of stent [not] because it was in the file of the patient but [because] it is impossible to [mask differences that appear on imaging],” Dr. Moreno replied. “Theoretically it is blinded, but it is difficult to maintain.”

Dr. King then referred to a slide presented by Dr. Moreno illustrating the cardiac event rate over follow-up, which reached 15.9% with SES and 11.1% with EES at 1 year (log-rank P value = 0.335). “It's always interesting to me to see these kind of curves that reflect the protocol-driven angiogram, which is obviously occurring here at 270 days,” Dr. King said, pointing out that EES showed a spike in events at that point whereas some SES-related events developed earlier. “It's just a question [of whether] there's any bias in the operator’s mind.”


Moreno R. Final results of the CIBELES trial: A randomised comparison between everolimus- and sirolimus-eluting stents in chronic coronary total occlusions.

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  • Dr. Moreno reports serving as a consultant to Abbott and Cordis.