Clinical Trials Day: How Trial Results Can Help Improve the Care Path of STEMI Patients
More than 200 years after James Lind experimented with citrus fruits as a way to fight scurvy in sailors – in what is thought to be the world’s first clinical trial – we mark May 20 as Clinical Trials Day. On this day, we spotlight and celebrate advances in clinical research. On top of the trials that led us to developments like the COVID-19 vaccine, the last few years have also seen studies that are particularly consequential for cardiovascular patients. One particular highlight is the BIOSTEMI trial.
BIOSTEMI: The First Published Randomized Superiority Trial Comparing Two Contemporary DES in STEMI Patients
2019’s BIOSTEMI trial, published in The Lancet, was the first direct comparison between two contemporary drug-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI), powered for superiority. STEMI patients can constitute up to 30 percent of cases needing a DES and the condition itself comes with high rates of morbidity and mortality. Unveiled at the 2019 ESC Congress, BIOSTEMI found that BIOTRONIK’s Orsiro® stent is superior to Abbott’s Xience stent when looking at target lesion failure (TLF) at 12 months1.
At a late-breaking session at CRT 2021, Co-Principal Investigator, Prof. Thomas Pilgrim, revealed that superiority continued at 24 months favoring the Orsiro DES that showed a TLF rate of 5.1%, compared to 8.1% for Xience. Thus, treatment with the Orsiro stent shows a 42% lower risk of TLF compared to the Xience stent and a 99.8% bayesian posterior probability of superiority in STEMI.2
In this patient group, vascular healing is a challenge due to the complex pro-thrombotic and inflammatory milieu.
BIOSTEMI included 1,300 patients across multiple centers in Switzerland and is the only recent trial to be powered for superiority assessing two contemporary DES in patients with STEMI.3
“In this patient group, vascular healing is a challenge due to the complex pro-thrombotic and inflammatory milieu. With Orsiro DES, we can incrementally improve their care path,” Co-Principal Investigator Dr. Juan F Iglesias originally noted in 2019.
“In contrast to the primary endpoint data at one-year, the two-year data show a significant difference between the two treatment arms, not only using Bayesian statistics incorporating a historical prior from the BIOSCIENCE trial, but also when analysed as an independent clinical trial,” added Co-Principal Investigator Prof. Thomas Pilgrim after recently presenting the updated data.
According to Prof. Pilgrim, the findings support the idea that even small differences in stent design may lead to important differences in clinical outcomes. He added that based upon the new data, Orsiro biodegradable polymer sirolimus-eluting stent “may be the new benchmark for drug-eluting stents.”
1 Iglesias JF, et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial. The Lancet. Published online: September 2, 2019. DOI: https://doi.org/10.1016/S0140- 6736(19)31877-X
2 Pilgrim T, Randomized Comparison Of Biodegradable Polymer Sirolimus-eluting Stents Versus Durable Polymer Everolimus-eluting Stents In Patients With ST-segment Elevation Myocardial Infarction: Final 2-year Outcomes Of The BIOSTEMI Randomized Trial. Presented at virtual CRT2021, March 13, 2021.
3 Pilgrim T, et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.
Orsiro DES is not currently indicated for STEMI patients.
Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
Xience is a trademark or registered trademark of the Abbott Group of Companies.