Chicago, IL - Unresolved questions from the REALITY trial, appearing in the February 22, 2006 issue of the Journal of the American Medical Association [1], may be answered by extended follow-up, an editorial accompanying the study suggests [2]. Designed to determine whether the Cypher sirolimus-eluting stent and Taxus paclitaxel-eluting stent are similarly safe and efficacious, the REALITY trial left cardiologists with as many questions as it set out to answer, Dr Sorin J Brener (Cleveland Clinic, OH) writes in his editorial.

Lead investigator Dr Marie-Claude Morice (Institut Cardiovasculaire Paris Sud, Massy, France) first presented the REALITY trial results at the 2005 American College of Cardiology meeting, as reported by heartwire. At the time, Morice commented, "I need to make clear, there are not enough data to select one drug-eluting stent over the other. They are both very durable and very efficient to prevent restenosis, and this has been shown one time more. We would need much more data to dramatically change practice."

As Brener points out, REALITY cannot provide data on specific subgroups in whom practitioners might be especially interested in which stent to choose: too few diabetics, patients with long lesions, and patients with bifurcation lesions were included in the trial for adequate conclusions to be drawn.

REALITY also does not settle the question of stent thrombosis, which trended higher in the Taxus-treated patients. Much was made of this higher absolute number of stent thromboses when the trial was first presented, but it does not receive special attention in the published study.

"Further analyses and studies are needed to learn about the effect of stent choice in patients with diabetes and those with long or bifurcating lesions," Brener writes. "More important, extended follow-up over 24 months may answer two critical clinical questions: Will the better inhibition of neointimal proliferation with sirolimus-eluting stents eventually result in a clinically meaningful improvement in outcome? And will the choice of stent affect the incidence of late stent thrombosis after discontinuation of dual antiplatelet therapy? Answers to these two questions may well determine the specific way these very helpful devices can be used best."