BIOSTEMI Extended Survival
- Conditions
- Coronary Artery DiseaseAcute Coronary Syndrome
- Registration Number
- NCT05484310
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
- Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
- Subject willing and able to provide oral informed consent.
- No specific exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization 5 years of follow-up Clinical assessment
- Secondary Outcome Measures
Name Time Method Cardiac death 5 years of follow-up Clinical assessment
Target vessel myocardial re-infarction 5 years of follow-up Clinical assessment
Clinically indicated and not clinically indicated target lesion revascularization 5 years of follow-up Clinical assessment
All-cause death 5 years of follow-up Clinical assessment
Clinically indicated and not clinically indicated target vessel revascularization 5 years of follow-up Clinical assessment
Any revascularization 5 years of follow-up Clinical assessment
Any myocardial infarction (Q-wave and non-Q-wave) 5 years of follow-up Clinical assessment
Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization 5 years of follow-up Clinical assessment
Definite stent thrombosis 5 years of follow-up Clinical assessment
Definite/probable stent thrombosis 5 years of follow-up Clinical assessment
Trial Locations
- Locations (10)
Inselspital, Bern University Hospital
🇨🇭Bern, Switzerland
Basel University Hospital
🇨🇭Basel, Switzerland
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
Spital Wallis
🇨🇭Sion, Switzerland
Triemli Hospital
🇨🇭Zürich, Switzerland
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Hôpital Cantonal de Fribourg
🇨🇭Fribourg, Switzerland
Geneva University Hospitals
🇨🇭Geneva, Switzerland
Lausanne University Hospitals
🇨🇭Lausanne, Switzerland
Kantonsspital St.Gallen
🇨🇭Saint Gallen, Switzerland