Clinical trial NCT05484310: BIOSTEMI Extended Survival
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: ST-segment elevation myocardial infarction
Long-term outcomes
Primary PCI
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2022-08-02
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BIOSTEMI ES includes only participants of the BIOSTEMI trial, i.e. patients with acute STEMI presenting within 24 hours of symptom onset undergoing primary PCI. At PCI, the randomly allocated stent (Orsiro® vs Xience®) was implanted in the culprit lesion of the target vessel.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization
timeFrame: 5 years of follow-up
Secondary outcomes:
measure: Cardiac death
timeFrame: 5 years of follow-up
measure: All-cause death
timeFrame: 5 years of follow-up
measure: Target vessel myocardial re-infarction
timeFrame: 5 years of follow-up
measure: Any myocardial infarction (Q-wave and non-Q-wave)
timeFrame: 5 years of follow-up
measure: Clinically indicated and not clinically indicated target lesion revascularization
timeFrame: 5 years of follow-up
measure: Clinically indicated and not clinically indicated target vessel revascularization
timeFrame: 5 years of follow-up
measure: Any revascularization
timeFrame: 5 years of follow-up
measure: Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization
timeFrame: 5 years of follow-up
measure: Definite stent thrombosis
timeFrame: 5 years of follow-up
measure: Definite/probable stent thrombosis
timeFrame: 5 years of follow-up
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Basel University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
city: Fribourg
country: Switzerland
facility: Hôpital Cantonal de Fribourg
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lausanne
country: Switzerland
facility: Lausanne University Hospitals
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Sion
country: Switzerland
facility: Spital Wallis
city: Zürich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Thomas Pilgrim, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Juan F. Iglesias, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.