BIOSTEMI Extended Survival

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization | Clinical assessment | 5 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | Clinical assessment | 5 years of follow-up | 
| All-cause death | Clinical assessment | 5 years of follow-up | 
| Target vessel myocardial re-infarction | Clinical assessment | 5 years of follow-up | 
| Any myocardial infarction (Q-wave and non-Q-wave) | Clinical assessment | 5 years of follow-up | 
| Clinically indicated and not clinically indicated target lesion revascularization | Clinical assessment | 5 years of follow-up | 
| Clinically indicated and not clinically indicated target vessel revascularization | Clinical assessment | 5 years of follow-up | 
| Any revascularization | Clinical assessment | 5 years of follow-up | 
| Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization | Clinical assessment | 5 years of follow-up | 
| Definite stent thrombosis | Clinical assessment | 5 years of follow-up | 
| Definite/probable stent thrombosis | Clinical assessment | 5 years of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-segment elevation myocardial infarction, Long-term outcomes, Primary PCI