Acute and long-term outcomes of the novel side access (SLK-View™) stent for bifurcation coronary lesions:: A multicenter nonrandomized feasibility study

Objective: To evaluate technical feasibility and procedural safety of SLK-View (TM) stent for treating bifurcation lesions. Background: Percutaneous treatment of coronary bifurcation lesions represents a technical challenge. Several stenting techniques and dedicated devices have proven unsuccessful, with high rates of side branch occlusion at index procedure and follow-up. Methods: Eighty one patients with 84 de novo coronary artery lesions involving a major side branch underwent SLK-View (TM) (Advanced Stent Technologies, Inc., Pleasanton, CA) stent implantation with subsequent kissing balloon post dilatation. SLK-View (TM) stent is a new scaffolding device incorporating a side aperture that allows access to the side-branch of a bifurcation after deployment of the stent in main vessel. All patients underwent angiographic follow-up at 6 months. Procedural, in-hospital, and 6-month follow-up outcomes were examined. Results: The lesions were located in left main (n = 11), left anterior descending (n = 50), left circumflex (n 8), right coronary artery (n 7), and 1 ramus intermedius. The most frequent lesions (44.1%) were true bifurcations. Successful stent delivery to bifurcation was accomplished in 82/84 of the cases (97.6%). Technical success was obtained in 99 and 94% of main vessel and side branches, respectively. Stenting in side-branch was performed in 21 lesions (25%). Side-branches were accessed effectively in 100% of bifurcations postprocedurally. Binary restenosis rate at 6-month follow-up was 28.3% and 37.7% for main vessel and side-branch, respectively. TLR rate at 6-month follow-up was 21% and CABG rate of 6%. Conclusion: In this consecutive multicenter series of patients with coronary bifurcation lesions, this novel side-branch access stent proved feasible, with a high procedural success rate, while maintaining side-branch access. (c) 2006 Wiley-Liss, Inc.