Direct stenting with sirolimus-eluting stents.

The sirolimus-eluting stent has been studied extensively in randomized controlled trials of patients with native de novo coronary lesions. Lesion predilation before stent placement has been the predominant implantation strategy in these trials. Direct implantation of the sirolimus-eluting stent without lesion predilation has been undertaken at the investigators' discretion in certain trials as well as in patients enrolled in a post-marketing surveillance registry, and was the intended implantation strategy in the DIRECT trial. Comparisons with patients receiving sirolimus-eluting stents after lesion predilation in the trials and the registry were all confounded by imbalances in patient, lesion, and/or procedural characteristics and point to the highly selective nature of the direct-stenting strategy. At present, direct implantation of the sirolimus-eluting stent appears to be safe and as effective as conventional (predilated) stenting, provided that the targeted coronary lesion is amenable to the direct approach. Since a randomized trial of implantation strategies is lacking, there is no conclusive evidence as to the hypothesized superiority of direct over predilated stenting in suitable coronary lesions.