SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

Detailed Summary

BACKGROUND: Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of DES and the technique for stent implantation have not been clarified. The side-branch (SB) is emerging as critical point, accounting for more than a third of the significant restenosis in the DES era. A series of data supports the adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a conservative approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal angiographic result has not been clarified. AIMS OF THE STUDY: The aims of the present study are: 1. to compare in a prospective randomized study the acute 3D angiographic results and the late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES) obtained using a provisional TAP-stenting technique. 2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal angiographic result in the SB after stenting. METHODS TO BE APPLIED: 150 consecutive patients with bifurcated lesions undergoing PCI with the provisional TAP-stenting technique will be randomized to SES or EES implantation. Procedural and post-PCI details will be prospectively recorded. The subgroup of patients in which complete revascularization has been achieved will enter a systematic assessment of inducible ischemia by early and late exercise tests. Off line 3D QCA assessment will be performed and used to divide the study population in 2 groups according to the SB residual stenosis: * Group O (optimal SB angiographic result): post-PCI SB area stenosis\<50% * Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis\>50%. PRIMARY STUDY END-POINTS. 1. COMPARISON BETWEEN SES AND EES: SB acute angiographic result; SB trouble; target bifurcation failure. 2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization: inducible ischemia at the early exercise test or occurrence of early spontaneous ischemia related to the SB.

Study Details

Timeline

Interventions