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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,300
Kantonsspital Aarau
Aarau, Switzerland
Basel University Hospital
Basel, Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland
Hôpital Cantonal de Fribourg
Fribourg, Switzerland
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
Time frame: 5 years of follow-up
Cardiac death
Clinical assessment
Time frame: 5 years of follow-up
All-cause death
Clinical assessment
Time frame: 5 years of follow-up
Target vessel myocardial re-infarction
Clinical assessment
Time frame: 5 years of follow-up
Any myocardial infarction (Q-wave and non-Q-wave)
Clinical assessment
Time frame: 5 years of follow-up
Clinically indicated and not clinically indicated target lesion revascularization
Clinical assessment
Time frame: 5 years of follow-up
Clinically indicated and not clinically indicated target vessel revascularization
Clinical assessment
Time frame: 5 years of follow-up
Any revascularization
Clinical assessment
Time frame: 5 years of follow-up
Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization
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Geneva University Hospitals
Geneva, Switzerland
Lausanne University Hospitals
Lausanne, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Spital Wallis
Sion, Switzerland
Triemli Hospital
Zurich, Switzerland
Clinical assessment
Time frame: 5 years of follow-up
Definite stent thrombosis
Clinical assessment
Time frame: 5 years of follow-up
Definite/probable stent thrombosis
Clinical assessment
Time frame: 5 years of follow-up