EES Noninferior to SES for Treating Total Coronary Occlusions

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Everolimus-eluting stents (EES) are noninferior to sirolimus-eluting stents (SES) for preventing late luminal loss in chronic coronary occlusions, according to the results of a randomized trial published online February 12, 2013, ahead of print in Circulation: Cardiovascular Interventions. Taking into account a trend for reduced stent thrombosis with EES, the authors recommend the newer devices as the first choice in treating such lesions.

For the CIBELES trial, researchers led by Raul Moreno, MD, of the University Hospital La Paz (Madrid, Spain), randomized 207 patients with coronary total occlusions present for more than 2 weeks to PCI with EES (n = 106; Xience V, Abbott Vascular, Santa Clara, CA) or SES (n = 101, Cypher, Cordis, Warren, NJ) at 13 centers in Spain and Portugal.

At 9-month angiographic follow-up, the difference in in-stent late loss between the 2 stent types (-0.16 mm; 95% CI 0.04 to -0.36) met the criterion for noninferiority with EES vs. SES by falling within a margin of 0.20 mm (P < 0.01). Other angiographic endpoints including binary restenosis and vessel reocclusion were also equivalent (table 1).

Table 1. Nine-Month Angiographic Outcomes

At 1 year clinical follow-up, rates of death, TVR,and stroke were similar between the 2 stent types, with EES showing trends for fewer MIs and definite or probable stent thromboses (table 2).

Table 2. One-Year Clinical Outcomes

The overall incidence of MACE at 12 months was 15.9% with SES vs. 11.1% with EES (P = 0.335).

The study authors note that true chronic total occlusions (CTOs) are present for over 3 months. In the CIBELES trial, 80% of patients had actual CTO lesions. Patients with and without CTOs had similar rates of freedom from MACE at 12 months (85.8% vs. 92.3%; P = 0.256), binary angiographic restenosis (9.7% vs. 2.4%; P = 0.234), and vessel reocclusion (1.8% vs. 2.0%; P = 0.469).

In real-world practice, 13% to 18% of patients undergoing coronary angiography have total coronary occlusions, the researchers report, noting that this population represents “one of the most difficult scenarios for interventional cardiologists.” CIBELES, they add, is the largest trial thus far to compare DES in this patient group.

The results, they conclude, “support the use of [EES] as the first-choice device in successfully recanalized chronic coronary occlusions.”

Dr. Moreno and colleagues note that EES hold 2 distinct advantages compared with older first-generation stents: a more flexible platform due to thinner struts and a cobalt-chromium alloy, and a thinner, more biocompatible polymer.

Study Details

In addition to occlusion time of more than 2 weeks, eligible patients had to have TIMI flow grade 0 or 1 as well as angina, silent ischemia, or viable myocardium at the area supplied by the target vessel.

Source:

Moreno R, García E, Teles R, et al. 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;Epub ahead of print.

Disclosure:

• The study was supported by the Spanish Society of Cardiology, with an unrestricted grant by Abbott Vascular.
• Dr. Moreno reports no relevant conflicts of interest.

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