Clinical trial NCT02579031: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: Percutaneous Coronary Intervention
Stents
Drug-Eluting Stents
Coronary Artery Disease
Acute Coronary Syndrome
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2015-10-19
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: up to 12 months
Secondary outcomes:
measure: Number of patients with clinically indicated and not clinically indicated target lesion revascularization (TLR)
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with clinically indicated and not clinically indicated target vessel revascularization (TVR)
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with target vessel failure (TVF)
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with cardiac death
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with all-cause death (cardiac and non-cardiac)
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with myocardial infarction (Q-wave and non-Q-wave)
timeFrame: up to 30 days, 1 and 2 years
measure: Number of patients with definite stent thrombosis
timeFrame: up to 30 days, 1 and 2 years
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Bern University Hospital, Dep. of Cardiology
city: Freiburg
country: Switzerland
facility: Universität Freiburg
city: Genf
country: Switzerland
facility: HUG
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Sion
country: Switzerland
facility: Spital Wallis
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Triemli
Study officials:
affiliation: Dep. of Cardiology, Bern University Hospital
name: Thomas Pilgrim, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
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