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

June 14, 2010 updated by: Catholic University of the Sacred Heart

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Institute of Cardiology - Catholic University of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SES
Patients with coronary bifurcation lesions treated by Sirolimus eluting stent
Device: Sirolimus eluting stent
Implantation of Sirolimus eluting stent
Other Names:
  • 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 Names:
  • Xience stent - Abbot company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACUTE ANGIOGRAPHIC RESULT
Time Frame: 7 DAYS
  • "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.
7 DAYS
SIDE BRANCH TROUBLE
Time Frame: 7 DAYS

"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.
7 DAYS
TARGET BIFURCATION FAILURE
Time Frame: 18 MONTHS
- target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.
18 MONTHS
6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure)
Time Frame: 18 MONTHS
18 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TECHNICAL CHARACTERISTICS
Time Frame: 7 DAYS
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)
7 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Francesco Burzotta, MD,PhD,FESC, Catholic University Of Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2010

Last Update Submitted That Met QC Criteria

June 14, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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