BIOSTEMI ES: BIOSTEMI Extended Survival
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
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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.
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Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up.
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As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years.
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Cardiac death [5 years of follow-up]
Clinical assessment
- All-cause death [5 years of follow-up]
Clinical assessment
- Target vessel myocardial re-infarction [5 years of follow-up]
Clinical assessment
- Any myocardial infarction (Q-wave and non-Q-wave) [5 years of follow-up]
Clinical assessment
- Clinically indicated and not clinically indicated target lesion revascularization [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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
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Subject willing and able to provide oral informed consent.
Exclusion Criteria:
- No specific exclusion criteria.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Kantonsspital Aarau | Aarau | Switzerland | 5001 | |
2 | Basel University Hospital | Basel | Switzerland | 4031 | |
3 | Inselspital, Bern University Hospital | Bern | Switzerland | 3010 | |
4 | Hôpital Cantonal de Fribourg | Fribourg | Switzerland | 1700 | |
5 | Geneva University Hospitals | Geneva | Switzerland | 1205 | |
6 | Lausanne University Hospitals | Lausanne | Switzerland | 1011 | |
7 | Kantonsspital Luzern | Luzern | Switzerland | 6000 | |
8 | Kantonsspital St.Gallen | Saint Gallen | Switzerland | 9007 | |
9 | Spital Wallis | Sion | Switzerland | 1951 | |
10 | Triemli Hospital | Zürich | Switzerland | 8063 |
Sponsors and Collaborators
- University Hospital, Geneva
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Thomas Pilgrim, Pr, University Hospital Inselspital, Berne
- Principal Investigator: Juan F. Iglesias, PD Dr, University Hospital, Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
- Iglesias JF, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, Weilenmann D, Kaiser C, Tapponnier M, Stortecky S, Losdat S, Eeckhout E, Valgimigli M, Odutayo A, Zwahlen M, Jüni P, Windecker S, Pilgrim T. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial. Lancet. 2019 Oct 5;394(10205):1243-1253. doi: 10.1016/S0140-6736(19)31877-X. Epub 2019 Sep 2.
- Iglesias JF, Muller O, Zaugg S, Roffi M, Kurz DJ, Vuilliomenet A, Weilenmann D, Kaiser C, Tapponnier M, Heg D, Valgimigli M, Eeckhout E, Jüni P, Windecker S, Pilgrim T. 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: rationale and design of the BIOSTEMI trial. EuroIntervention. 2018 Aug 20;14(6):692-699. doi: 10.4244/EIJ-D-17-00734.
- Pilgrim T, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, Weilenmann D, Kaiser C, Tapponnier M, Losdat S, Eeckhout E, Valgimigli M, Jüni P, Windecker S, Iglesias JF. Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial. JACC Cardiovasc Interv. 2021 Mar 22;14(6):639-648. doi: 10.1016/j.jcin.2020.12.011.
- 2021-01928