BIOTRONIK Announces Completion of Patient Enrollment in BIOSTEMI Study
Trial set to Evaluate Superiority of Orsiro DES vs Xience EES in patients with ST-Elevation Myocardial Infarction (STEMI)
BIOTRONIK announced today that patient enrollment for the BIOSTEMI study has been completed. STEMI is a potentially fatal type of heart attack, caused by prolonged obstruction of blood supply in the heart. More than 730,000 cardiac artery disease (CAD) patients globally lost their lives to STEMI heart attacks in 20161.
BIOSTEMI, a randomized, controlled superiority study, is the first trial intended to confirm the superiority of the Orsiro2 hybrid drug-eluting stent (DES) to the Xience Xpedition3 (EES) in patients with ST-Elevation Myocardial Infarction (STEMI), after a statistically significant difference was seen in the STEMI subgroup of the BIOSCIENCE trial in a smaller cohort (n=407). Indeed, results from the STEMI subgroup show that the target lesion failure rate at 24 months was 5.4% vs. 10.8% in Orsiro and Xience respectively. The difference was significant: p=0.043.
“In the earlier BIOSCIENCE trial, Orsiro was associated with a reduced risk of the primary endpoint TLF, for a subgroup of 407 STEMI patients. Once we became aware of Orsiro’s potential benefit for such patients, the next logical step was to attempt to extend these results in a dedicated randomized trial. Today we are proud to announce that the last patient of the BIOSTEMI trial has been enrolled; the 1-year results of the study are expected for EuroPCR 2019,” commented principal investigator Dr. Juan F. Iglesias, Geneva University Hospital (HUG), Geneva, Switzerland.
The investigator-initiated, international multi-center BIOSTEMI trial has currently enrolled 1,250 patients in 16 study centers across Switzerland and Italy. STEMI patients were randomized to receive treatment with either Orsiro or Xience Xpedition. BIOSTEMI’s primary endpoint is Target Lesion Failure (TLF) at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization. Follow up is planned at five years. More details of the trial design were published in EuroIntervention at the beginning of December 20174.
“After the extremely promising result of the BIOSCIENCE STEMI subgroup, we are confident that the BIOSTEMI trial will confirm Orsiro’s effectiveness in the challenging STEMI indication.” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK.
2CAUTION - Investigational device in the United States. Limited by US law to investigational use.
3Xience/Xience Xpedition are registered trademarks of Abbott Cardiovascular Systems.
4Iglesias J.F. et al. EuroIntervention 2017: DOI:10.4244/EIJ-D-17-00734
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.