BIOTRONIK Announces Completion of Patient Enrollment in BIOSTEMI Study

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.

References:

^{1https://vizhub.healthdata.org/gbd-compare}

^{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}