A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (BIOSTEMI)

September 1, 2020 updated by: University Hospital Inselspital, Berne

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in MACE among patients with STEMI undergoing primary PCI with newer generation stents with enhanced biocompatibility.

The present trial aims at filling the current gap of evidence by providing randomized data to establish the superior clinical outcome with an ultrathin strut third-generation DES with biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing primary PCI, compared to the current state-of-the art second-generation DES with permanent polymer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background

Primary percutaneous coronary intervention (PCI) is considered nowadays as the reperfusion strategy of choice for patients with acute ST-segment elevation myocardial infarction (STEMI, owing to a lower risk of myocardial re-infarction and improved short- and long-term survival compared to fibrinolysis. However, STEMI is still associated with poorer clinical outcomes after PCI, compared to stable CAD, with higher rates of stent thrombosis and an increased risk of myocardial re-infarction persisting throughout long-term follow-up. recent data from randomized controlled trials and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in major adverse cardiac events among patients with STEMI undergoing primary PCI with third-generation DESs, compared with both first-generation and second-generation DESs with durable polymer. Importantly, this signal suggesting superiority of third-generation DESs in patients with STEMI has never been demonstrated with second-generation DESs. Third-generation DESs with enhanced biocompatibility may therefore have a particular clinical benefit in high-risk subgroups of patients with delayed vascular healing but these data warrants confirmation in appropriately designed randomized controlled trials.

Objective

The purpose of the study is to compare the safety and efficacy of a novel biodegradable-polymer sirolimus-eluting stent (Orsiro®) with a durable-polymer everolimus-eluting stent (Xience Xpedition or Xience Alpine®) in a superiority trial among patients presenting with acute STEMI and undergoing primary PCI.

Methods

Eligible patients with acute STEMI presenting within 24 hours of symptom onset will undergo primary PCI. At PCI, the randomly allocated stent has to be implanted in the culprit lesion of the target vessel.

Patients will be followed-up with a hospital visit at 12 months. Patients will be followed-up for clinical endpoints by telephone at 30 days and 2 years.

Study Type

Interventional

Enrollment (Actual)

1300

Phase

  • Not Applicable

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

  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital Aarau
      • Basel, Switzerland
        • Universitatsspital Basel
      • Bern, Switzerland, 3010
        • Bern University Hospital, Dep. of Cardiology
      • Freiburg, Switzerland
        • Universität Freiburg
      • Genf, Switzerland
        • HUG
      • Lausanne, Switzerland, 1011
        • Lausanne University Hospital
      • Luzern, Switzerland
        • Kantonsspital Luzern
      • Sion, Switzerland
        • Spital Wallis
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen
      • Zürich, Switzerland
        • Triemli

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • ST-segment elevation acute myocardial infarction
  • Primary PCI occurring within 24 hours of symptom onset
  • Presence of ≥1 acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple coronary stents

Exclusion Criteria

  • Known allergy to aspirin, Ticagrelor, Prasugrel, Clopidogrel, Sirolimus, Everolimus or contrast media
  • Planned surgery within 6 months of primary PCI, unless dual antiplatelet therapy could be maintained throughout the peri-surgical period
  • Currently participating in another trial before reaching the primary endpoint
  • Inability to provide informed consent
  • Non-cardiac comorbid conditions with life expectancy of less than 1 year
  • Mechanical complication of acute myocardial infarction
  • Acute myocardial infarction due to stent thrombosis

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Orsiro
Novel biodegradable-polymer sirolimus-eluting stent Orsiro
Device: Orsiro
Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention
Active Comparator: Xience
Durable-polymer everolimus-eluting stent Xience
Device: Xience
Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (Q-wave and non-Q-wave), or clinically driven target lesion revascularization
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with clinically indicated and not clinically indicated target lesion revascularization (TLR)
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with clinically indicated and not clinically indicated target vessel revascularization (TVR)
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with target vessel failure (TVF)
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with cardiac death
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with all-cause death (cardiac and non-cardiac)
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with myocardial infarction (Q-wave and non-Q-wave)
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years
Number of patients with definite stent thrombosis
Time Frame: up to 30 days, 1 and 2 years
up to 30 days, 1 and 2 years

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Thomas Pilgrim, Prof. Dr. med., Dep. of Cardiology, Bern University Hospital

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 (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 288/15

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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