BIOSTEMI Extended Survival

NCT05484310 | Completed DMC

• 1 other identifier: 2021-01928
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 10

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

ST-segment elevation myocardial infarction; Long-term outcomes; Primary PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Cardiac death

  5 years of follow-up

• All-cause death

  5 years of follow-up

• Target vessel myocardial re-infarction

  5 years of follow-up

• Any myocardial infarction (Q-wave and non-Q-wave)

  5 years of follow-up

• Clinically indicated and not clinically indicated target lesion revascularization

  5 years of follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
• Subject willing and able to provide oral informed consent.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (10)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Basel University Hospital

Basel, 4031, Switzerland

Location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Hôpital Cantonal de Fribourg

Fribourg, 1700, Switzerland

Location

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Lausanne University Hospitals

Lausanne, 1011, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Spital Wallis

Sion, 1951, Switzerland

Location

Triemli Hospital

Zurich, 8063, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 29205157 BACKGROUND

• 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.

  PMID: 31488372 BACKGROUND

• 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.

  PMID: 33727005 BACKGROUND

• 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.

  PMID: 37898137 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Thomas Pilgrim, Pr

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Juan F. Iglesias, PD Dr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: October 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: October 28, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CH (10)