Data from Pharmawand - Curated by EPG Health - Date added 14 March 2018
Biotronik announced 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 2016.
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. 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 2017.