Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1300 participants
OBSERVATIONAL
2021-10-15
2023-10-28
Brief Summary
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Detailed Description
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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.
* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subject willing and able to provide oral informed consent.
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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IGLESIAS Juan Fernando
PD Dr
Principal Investigators
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Thomas Pilgrim, Pr
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Juan F. Iglesias, PD Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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Kantonsspital Aarau
Aarau, , Switzerland
Basel University Hospital
Basel, , Switzerland
Inselspital, Bern University Hospital
Bern, , Switzerland
Hôpital Cantonal de Fribourg
Fribourg, , Switzerland
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
Countries
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References
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Iglesias JF, Muller O, Zaugg S, Roffi M, Kurz DJ, Vuilliomenet A, Weilenmann D, Kaiser C, Tapponnier M, Heg D, Valgimigli M, Eeckhout E, Juni 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.
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, Juni 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.
Pilgrim T, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, Weilenmann D, Kaiser C, Tapponnier M, Losdat S, Eeckhout E, Valgimigli M, Juni 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.
Iglesias JF, Roffi M, Losdat S, Muller O, Degrauwe S, Kurz DJ, Haegeli L, Weilenmann D, Kaiser C, Tapponnier M, Cook S, Cuculi F, Heg D, Windecker S, Pilgrim T. Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial. Lancet. 2023 Nov 25;402(10416):1979-1990. doi: 10.1016/S0140-6736(23)02197-9. Epub 2023 Oct 25.
Other Identifiers
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2021-01928
Identifier Type: -
Identifier Source: org_study_id