The first patient has been enrolled in Biotronik’s new BIOSTEMI trial, which is evaluating the safety and efficacy of the Orsiro hybrid drug-eluting stent, compared with Xience Xpedition (Abbott Vascular), in patients with ST-segment elevation myocardial infarction (STEMI). The BIOSCIENCE trial, according to a Biotronik press release, has already shown “highly promising results” for the Orsiro stent.
The investigator-initiated, international multicentre BIOSTEMI superiority trial is currently in the process of enrolling 1,250 patients at 16 study centres in Switzerland and Italy. STEMI patients will be randomised to undergo percutaneous coronary intervention (PCI) with Orsiro (a sirolimus-eluting stent with a biodegradable polymer) or with Xience Xpedition (an everolimus-eluting stent with a permanent polymer). The 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. All patients will be followed for up to five years. It is the first trial to directly compare Orsiro with Xience in patients with STEMI.
Juan F Iglesias (Lausanne University Hospital (CHUV), Lausanne, Switzerland) says: “As we currently have limited data available on the clinical performance of newer generation drug-eluting stents in STEMI patients, the problem of optimal drug-eluting stent therapy in this challenging patient population remains unresolved. During 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 randomised trial.”