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Coronary Artery DiseaseBIOSTEMI ESNCT05484310

BIOSTEMI Extended Survival

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University Hospital, Geneva at 10 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,300 participants
Where
10 sitesSwitzerland
Study dates
15 Oct 2021to 28 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • No specific exclusion criteria.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Switzerland10 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Basel University Hospital

    Basel, 4031

  • Inselspital, Bern University Hospital

    Bern, 3010

  • Hôpital Cantonal de Fribourg

    Fribourg, 1700

  • Geneva University Hospitals

    Geneva, 1205

  • Lausanne University Hospitals

    Lausanne, 1011

  • Kantonsspital Luzern

    Lucerne, 6000

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • Spital Wallis

    Sion, 1951

  • Triemli Hospital

    Zurich, 8063

Other trials in Switzerland

About this study

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

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.

Read the 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.
Keywords
ST-segment elevation myocardial infarction, Long-term outcomes, Primary PCI
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years of follow-up

Secondary outcomes (10)

  1. Cardiac death

    Clinical assessment

    Measured: 5 years of follow-up

  2. All-cause death

    Clinical assessment

    Measured: 5 years of follow-up

  3. Target vessel myocardial re-infarction

    Clinical assessment

    Measured: 5 years of follow-up

  4. Any myocardial infarction (Q-wave and non-Q-wave)

    Clinical assessment

    Measured: 5 years of follow-up

  5. Clinically indicated and not clinically indicated target lesion revascularization

    Clinical assessment

    Measured: 5 years of follow-up

  6. Clinically indicated and not clinically indicated target vessel revascularization

    Clinical assessment

    Measured: 5 years of follow-up

  7. Any revascularization

    Clinical assessment

    Measured: 5 years of follow-up

  8. Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization

    Clinical assessment

    Measured: 5 years of follow-up

  9. Definite stent thrombosis

    Clinical assessment

    Measured: 5 years of follow-up

  10. Definite/probable stent thrombosis

    Clinical assessment

    Measured: 5 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start15 Oct 2021
  3. Primary completion30 Apr 2023
  4. Study completion28 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484310
Sponsor's protocol ID
2021-01928
Acronym
BIOSTEMI ES
Status last verified
Nov 2023
First submitted
29 Jul 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD sharing plan will depend on editorial publication policies requirements.

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.

    PubMed 29205157

  • 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.

    PubMed 31488372

  • 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.

    PubMed 33727005

  • Iglesias JF, Roffi M, Heg D, Muller O, Kurz DJ, Haegeli L, Rigger J, Kaiser C, Girod G, Cook S, Bossard M, Losdat S, Windecker S, Pilgrim T. Impact of total stent length on long-term outcomes with different newer-generation drug-eluting stent designs in ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI ES randomized trial. Am Heart J. 2026 Jul;297:107421. doi: 10.1016/j.ahj.2026.107421. Epub 2026 Mar 10.

    PubMed 41812965

  • 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.

    PubMed 37898137

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University Hospital, Geneva at 10 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 5 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484310, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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BIOSTEMI Extended Survival (NCT05484310) | AzTrials