SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis
Condition: Coronary Artery Disease; Coronary Stenosis
MeSH terms: Coronary Artery Disease; Coronary Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Bifurcated lesions are challenging target lesions in percutaneous coronary interventions
      (PCI) which may specifically benefit from the usage of drug-eluting stents (DES). However,
      the selection of the type of DES and the technique for DES implantation have not been
      clarified. In spite of the technique adopted, 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 as this is not associated with
      worse outcome compared to more complex stenting strategies. 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 (as a
           measure of the impact of stent design) and the late clinical outcome of
           Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES) obtained using a provisional
           TAP-stenting approach to treat bifurcated lesions.

        2. to prospectively assess the clinical relevance (in terms of inducible ischemia) of
           suboptimal angiographic result in the SB of bifurcated lesions treated by 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 details,
      post-PCI cardiac enzyme release, clinical outcome up to 1 year will be prospectively
      recorded. After the procedure, the subgroup of patients in which complete revascularization
      has been achieved (no untreated stenosis >50% in any other vessel, no residual stenosis >50%
      in any other treated vessel), will enter a systematic assessment of inducible ischemia by
      early (<8 days) and late (6-month) 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% and 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": comparison of the 3DQCA-estimated MLD and MLA in
                the SB.

             -  "SB trouble": composite of: 1. occurrence of SB TIMI flow <3 after MV stenting
                throughout the procedure; 2. need of guidewire(s) different from BMW to re-wire SB
                after MV stenting; 3. failure to re-wire the SB after MV stenting; 4. failure to
                dilate the SB after MV stenting and SB re-wiring.

             -  target bifurcation failure (TBF) defined as target bifurcation-related major
                adverse coronary events (MACE) or target bifurcation angiographic failure.

        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:
           inducible ischemia (diagnostic ST-segment changes) at the early (<8 days) exercise test
           or occurrence of early (<12 weeks) spontaneous ischemia related to the SB (any ischemic
           episode requiring unplanned coronary angiography with documentation of main vessel
           patency).
    

Intervention name(s): Sirolimus eluting stent; Everolimus eluting stent
Intervention type(s): Device; Device
Intervention description(s): Implantation of Sirolimus eluting stent; Implantation of Everolimus eluting stent
Other intervention name(s): Cypher stent - Cordis (Johnson&Johnson Company); Xience stent - Abbot company
Intervention MeSH terms: Sirolimus; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty, Transluminal, Percutaneous Coronary; Drug-Eluting Stents