Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
ST-segment elevation myocardial infarction, Long-term outcomes, Primary PCI
Brief 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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization | 5 years of follow-up | Clinical assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Definite/probable stent thrombosis | 5 years of follow-up | Clinical assessment |
| Cardiac death | 5 years of follow-up | Clinical assessment |
| Clinically indicated and not clinically indicated target vessel revascularization | 5 years of follow-up | Clinical assessment |
| All-cause death | 5 years of follow-up | Clinical assessment |
| Definite stent thrombosis | 5 years of follow-up | Clinical assessment |
| Any revascularization | 5 years of follow-up | Clinical assessment |
| Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization | 5 years of follow-up | Clinical assessment |
| Any myocardial infarction (Q-wave and non-Q-wave) | 5 years of follow-up | Clinical assessment |
| Clinically indicated and not clinically indicated target lesion revascularization | 5 years of follow-up | Clinical assessment |
| Target vessel myocardial re-infarction | 5 years of follow-up | Clinical assessment |
Countries
Switzerland
Outcome results
None listed