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)
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|ClinicalTrials.gov Identifier: NCT02579031|
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : September 2, 2020
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|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||1300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Orsiro
Novel biodegradable-polymer sirolimus-eluting stent Orsiro
Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention
Active Comparator: Xience
Durable-polymer everolimus-eluting stent Xience
Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention
- 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 ]
- Number of patients with clinically indicated and not clinically indicated target lesion revascularization (TLR) [ Time Frame: 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 ]
- Number of patients with target vessel failure (TVF) [ Time Frame: up to 30 days, 1 and 2 years ]
- Number of patients with cardiac death [ Time Frame: 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 ]
- Number of patients with myocardial infarction (Q-wave and non-Q-wave) [ Time Frame: 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 ]
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
|Bern University Hospital, Dep. of Cardiology|
|Bern, Switzerland, 3010|
|Lausanne University Hospital|
|Lausanne, Switzerland, 1011|
|Kantonsspital St. Gallen|
|St. Gallen, Switzerland|
|Principal Investigator:||Thomas Pilgrim, Prof. Dr. med.||Dep. of Cardiology, Bern University Hospital|