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

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00697372
First received: June 11, 2008
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

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.

Condition Intervention Phase
Coronary Artery Disease
Coronary Stenosis
Device: Sirolimus eluting stent
Device: Everolimus eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure) [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]
  • ACUTE ANGIOGRAPHIC RESULT [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]
    • "MV acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the MV.
    • "SB acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the SB.

  • SIDE BRANCH TROUBLE [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]

    "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 [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]
    - target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.


Secondary Outcome Measures:
  • TECHNICAL CHARACTERISTICS [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]
    comparison of procedural time, fluoroscopy time, total x-ray exposure, contrast media volume usage, number of guidewires used to wire the SB, direct stenting failure rate, kissing balloon rate, occurrence of transient deterioration of blood flow through the SB (TIMI<3)


Enrollment: 150
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SES
Patients with coronary bifurcation lesions treated by Sirolimus eluting stent
Device: Sirolimus eluting stent
Implantation of Sirolimus eluting stent
Other Name: Cypher stent - Cordis (Johnson&Johnson Company)
Active Comparator: EES
Patients with coronary bifurcation lesions treated by Everolimus eluting stent
Device: Everolimus eluting stent
Implantation of Everolimus eluting stent
Other Name: Xience stent - Abbot company

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).
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • de novo bifurcated lesions
  • lesions >50% located in a major bifurcation point
  • TIMI >2 on both main vessel and side branch
  • main vessel visual diameter >2.5 mm
  • side branch visual diameter >2.0 mm
  • >18 years of age
  • signed the informed consent to enter the study

Exclusion Criteria:

  • known hypersensitivity to Sirolimus, Everolimus, cobalt, chromium, nickel, tungsten acrylic and fluoro-polymers
  • contraindications to double antiplatelet therapy acute (within 48 hours) ST-elevation acute myocardial infarction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697372

Locations
Italy
Institute of Cardiology - Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Francesco Burzotta, MD,PhD,FESC Catholic University of Sacred Heart
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Burzotta MD PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00697372     History of Changes
Other Study ID Numbers: P648
Study First Received: June 11, 2008
Last Updated: June 14, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Angioplasty, Transluminal, Percutaneous Coronary
Drug-Eluting Stents

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pathological Conditions, Anatomical
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014