NCT05484310

BIOSTEMI Extended Survival

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Timeline

• Start date: 2021-10-15
• Primary completion: 2023-04-30
• Completion: 2023-10-28
• First posted: 2022-08-02
• Last updated: 2023-11-29

Locations

10 sites across 1 country: Switzerland