CTU Bern


02.11.2023 – Final five-year follow-up results of a randomized trial in patients with ST elevation Myocardial infarction (STEMI) in need of catheter-directed revascularization have now been published.

Patients presenting with STEMI are in urgent need of re-opening the coronary artery causing the myocardial infarction; and this is often performed with a coronary stenting technique. The aim of the BIOSTEMI trial was to assess whether the use of biodegradable polymer sirolimus eluting stents (BP-SES) could improve clinical outcomes over two years; and now this follow-up has been extended (BIOSTEMI ES) to five years to evaluate longer term outcomes. The comparator stent was a durable polymer everolimus-eluting stent (DP-SES).

The BIOSTEMI ES study was investigator initiated and funded by Biotronik. It was designed as a randomized, superiority, multi-center trial and enrolled 1300 adults with STEMI in Switzerland. Patients were randomized to receive treatment with either BP-SES (used in 816 coronary lesions) or DP-SES (used in 806 coronary lesions). The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularization, at 5 years. Historical data on STEMI patients from the Bioscience randomized trial were used as prior information in a Bayesian design.

Primary endpoint data were less complete for 196 patients (98 patients BP-SES and DP-EES each), due to the extra consenting needed for ES and earlier consent withdrawals, in these cases only the BIOSTEMI follow-up data could be used (up to 2 years). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with BP-SES, and in 72 (11%) patients treated with DP-EES (difference of –3%; RR 0·70, 95% Bayesian credible interval 0·51–0·95; Bayesian posterior probability for superiority 0·988).

CTU Bern and Webspirit (Ulm) were heavily involved from the planning until the publication of the trial; Webspirit was responsible for the trial database (Data Management); CTU Bern was responsible for the quality of the data (Central Data Monitoring and on-site Monitoring) and the full statistical analysis process (Statistics and Methodology).

Please find the publication here: https://doi.org/10.1016/S0140-6736(23)02197-9