BIOSTEMI Extended Survival (BIOSTEMI ES)

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.