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BIOSTEMI Extended Survival (BIOSTEMI ES)

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Coronary Artery Disease
Acute Coronary Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT05484310
2021-01928

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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