Biotronik has announced that patient enrolment for the BIOSTEMI study has been completed. A press release explains that BIOSTEMI—a randomised, controlled superiority study—is the first trial intended to confirm the superiority of the Orsiro (Biotronik) hybrid drug-eluting stent to the Xience Xpedition (Abbott) in patients with ST-segment 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).
The press release adds that result 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.
The investigator-initiated, international multicentre BIOSTEMI trial has currently enrolled 1,250 patients in 16 study centres across Switzerland and Italy. STEMI patients were randomised to receive treatment with either Orsiro or Xience Xpedition. BIOSTEMI’s primary endpoint is target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularisation. Follow up is planned at five years. More details of the trial design were published in EuroIntervention at the beginning of December 2017.
Principal investigator Juan F Iglesias (Geneva University Hospital (HUG), Geneva, Switzerland) comments: “In the earlier BIOSCIENCE trial, Orsiro was associated with a reduced risk of the primary endpoint target lesion failure, 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. We are proud to announce that the last patient of the BIOSTEMI trial has been enrolled; the one-year results of the study are expected for EuroPCR 2019.”
Alexander Uhl (senior vice president Corporate Marketing, Biotronik) states: “After the extremely promising results of the BIOSCIENCE STEMI subgroups, we are confident that the BIOSTEMI trial will confirm Orsiro’s effectiveness in the challenging STEMI indication.”