BIOSTEMI Extended Survival (BIOSTEMI ES)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 1300

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
  • Basel, Switzerland, 4031
    • Basel University Hospital
  • Bern, Switzerland, 3010
    • Inselspital, Bern University Hospital
  • Fribourg, Switzerland, 1700
    • Hôpital Cantonal de Fribourg
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals
  • Lausanne, Switzerland, 1011
    • Lausanne University Hospitals
  • Luzern, Switzerland, 6000
    • Kantonsspital Luzern
  • Saint Gallen, Switzerland, 9007
    • Kantonsspital St.Gallen
  • Sion, Switzerland, 1951
    • Spital Wallis
  • Zürich, Switzerland, 8063
    • Triemli Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Clinical assessment	5 years of follow-up
All-cause death	Clinical assessment	5 years of follow-up
Target vessel myocardial re-infarction	Clinical assessment	5 years of follow-up
Any myocardial infarction (Q-wave and non-Q-wave)	Clinical assessment	5 years of follow-up
Clinically indicated and not clinically indicated target lesion revascularization	Clinical assessment	5 years of follow-up
Clinically indicated and not clinically indicated target vessel revascularization	Clinical assessment	5 years of follow-up
Any revascularization	Clinical assessment	5 years of follow-up
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
Definite stent thrombosis	Clinical assessment	5 years of follow-up
Definite/probable stent thrombosis	Clinical assessment	5 years of follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Juan F. Iglesias, PD Dr, University Hospital, Geneva; Principal Investigator: Thomas Pilgrim, Pr, Insel Gruppe AG, University Hospital Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Primary PCI; ST-segment elevation myocardial infarction; Long-term outcomes
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: 2021-01928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing plan will depend on editorial publication policies requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No