Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02579031
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Device: Orsiro Device: Xience Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of patients with clinically indicated and not clinically indicated target lesion revascularization (TLR) [ Time Frame: up to 30 days, 1 and 2 years ]
  2. Number of patients with clinically indicated and not clinically indicated target vessel revascularization (TVR) [ Time Frame: up to 30 days, 1 and 2 years ]
  3. Number of patients with target vessel failure (TVF) [ Time Frame: up to 30 days, 1 and 2 years ]
  4. Number of patients with cardiac death [ Time Frame: up to 30 days, 1 and 2 years ]
  5. Number of patients with all-cause death (cardiac and non-cardiac) [ Time Frame: up to 30 days, 1 and 2 years ]
  6. Number of patients with myocardial infarction (Q-wave and non-Q-wave) [ Time Frame: up to 30 days, 1 and 2 years ]
  7. Number of patients with definite stent thrombosis [ Time Frame: up to 30 days, 1 and 2 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579031


Locations
Layout table for location information
Switzerland
Kantonsspital Aarau
Aarau, Switzerland
Universitätsspital Basel
Basel, Switzerland
Bern University Hospital, Dep. of Cardiology
Bern, Switzerland, 3010
Universität Freiburg
Freiburg, Switzerland
HUG
Genf, Switzerland
Lausanne University Hospital
Lausanne, Switzerland, 1011
Kantonsspital Luzern
Luzern, Switzerland
Spital Wallis
Sion, Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland
Triemli
Zürich, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Lausanne Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Thomas Pilgrim, Prof. Dr. med. Dep. of Cardiology, Bern University Hospital
Publications of Results:
Kolh P, Windecker S, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; European Society of Cardiology Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol Ç, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; EACTS Clinical Guidelines Committee, Sousa Uva M, Achenbach S, Pepper J, Anyanwu A, Badimon L, Bauersachs J, Baumbach A, Beygui F, Bonaros N, De Carlo M, Deaton C, Dobrev D, Dunning J, Eeckhout E, Gielen S, Hasdai D, Kirchhof P, Luckraz H, Mahrholdt H, Montalescot G, Paparella D, Rastan AJ, Sanmartin M, Sergeant P, Silber S, Tamargo J, ten Berg J, Thiele H, van Geuns RJ, Wagner HO, Wassmann S, Wendler O, Zamorano JL; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions. 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg. 2014 Oct;46(4):517-92. doi: 10.1093/ejcts/ezu366. Epub 2014 Aug 29.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02579031    
Other Study ID Numbers: 288/15
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Keywords provided by University Hospital Inselspital, Berne:
Percutaneous Coronary Intervention
Stents
Drug-Eluting Stents
Coronary Artery Disease
Acute Coronary Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Pathologic Processes
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases