BIOSTEMI ES: BIOSTEMI Extended Survival

Sponsor
University Hospital, Geneva (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05484310
Collaborator
University Hospital Inselspital, Berne (Other)
1,300
10
17.5
130
7.4

Study Details

Study Description

Brief Summary

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.

    • In the BIOSTEMI randomized controlled clinical trial, the Orsiro ultrathin-strut bio degradable polymer sirolimus-eluting stent was found superior to the best-in-class Xience thin-strut durable polymer everolimus-eluting stent with respect to target lesion failure at one-year follow-up among patients with STEMI undergoing primary PCI (Iglesias JF, et al., Lancet 2019). The difference was driven by a lower risk of clinically indicated target lesion revascularization with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent.

    • Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up.

    • As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years.

    • The long-term clinical benefits the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent over the Xience thin-strut durable polymer everolimus-eluting stent beyond the polymer degradation period remain uncertain.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Randomized Multicenter Comparison Between Ultrathin-strut Biodegradable Polymer Sirolimuseluting Stents and Durable Polymer Everolimus-eluting Stents for Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
    Actual Study Start Date :
    Oct 15, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization [5 years of follow-up]

      Clinical assessment

    Secondary Outcome Measures

    1. Cardiac death [5 years of follow-up]

      Clinical assessment

    2. All-cause death [5 years of follow-up]

      Clinical assessment

    3. Target vessel myocardial re-infarction [5 years of follow-up]

      Clinical assessment

    4. Any myocardial infarction (Q-wave and non-Q-wave) [5 years of follow-up]

      Clinical assessment

    5. Clinically indicated and not clinically indicated target lesion revascularization [5 years of follow-up]

      Clinical assessment

    6. Clinically indicated and not clinically indicated target vessel revascularization [5 years of follow-up]

      Clinical assessment

    7. Any revascularization [5 years of follow-up]

      Clinical assessment

    8. Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization [5 years of follow-up]

      Clinical assessment

    9. Definite stent thrombosis [5 years of follow-up]

      Clinical assessment

    10. Definite/probable stent thrombosis [5 years of follow-up]

      Clinical assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),

    • Subject willing and able to provide oral informed consent.

    Exclusion Criteria:
    • No specific exclusion criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kantonsspital Aarau Aarau Switzerland 5001
    2 Basel University Hospital Basel Switzerland 4031
    3 Inselspital, Bern University Hospital Bern Switzerland 3010
    4 Hôpital Cantonal de Fribourg Fribourg Switzerland 1700
    5 Geneva University Hospitals Geneva Switzerland 1205
    6 Lausanne University Hospitals Lausanne Switzerland 1011
    7 Kantonsspital Luzern Luzern Switzerland 6000
    8 Kantonsspital St.Gallen Saint Gallen Switzerland 9007
    9 Spital Wallis Sion Switzerland 1951
    10 Triemli Hospital Zürich Switzerland 8063

    Sponsors and Collaborators

    • University Hospital, Geneva
    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Thomas Pilgrim, Pr, University Hospital Inselspital, Berne
    • Principal Investigator: Juan F. Iglesias, PD Dr, University Hospital, Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    IGLESIAS Juan Fernando, PD Dr, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT05484310
    Other Study ID Numbers:
    • 2021-01928
    First Posted:
    Aug 2, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IGLESIAS Juan Fernando, PD Dr, University Hospital, Geneva
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2022