BIOSTEMI Extended Survival

Coronary Artery Disease Clinical Trial

— BIOSTEMI ES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484310
• Other study ID #: 2021-01928
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: October 28, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: October 28, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
Switzerland	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	Luzern
Switzerland	Kantonsspital St.Gallen	Saint Gallen
Switzerland	Spital Wallis	Sion
Switzerland	Triemli Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years of follow-up
Secondary	Cardiac death	Clinical assessment	5 years of follow-up
Secondary	All-cause death	Clinical assessment	5 years of follow-up
Secondary	Target vessel myocardial re-infarction	Clinical assessment	5 years of follow-up
Secondary	Any myocardial infarction (Q-wave and non-Q-wave)	Clinical assessment	5 years of follow-up
Secondary	Clinically indicated and not clinically indicated target lesion revascularization	Clinical assessment	5 years of follow-up
Secondary	Clinically indicated and not clinically indicated target vessel revascularization	Clinical assessment	5 years of follow-up
Secondary	Any revascularization	Clinical assessment	5 years of follow-up
Secondary	Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization	Clinical assessment	5 years of follow-up
Secondary	Definite stent thrombosis	Clinical assessment	5 years of follow-up
Secondary	Definite/probable stent thrombosis	Clinical assessment	5 years of follow-up