BIOSTEMI Trial to Establish Orsiro’s Enhanced Efficacy and Safety in Challenging Indication

BUELACH, Switzerland, May 11, 2016 – BIOTRONIK announced today the first patient enrolment in the BIOSTEMI trial. The randomized, controlled superiority trial is the first to directly compare the safety and efficacy of the Orsiro hybrid drug-eluting stent (DES) with Xience Xpedition in treating ST-segment elevation myocardial infarction (STEMI). STEMI is a potentially fatal type of heart attack caused by a prolonged obstruction of blood supply in the heart. Every year nearly 250,000 people experience STEMI heart attacks.

“As we currently have limited data available on the clinical performance of newer generation DES in STEMI patients, the problem of optimal DES therapy in this challenging patient population remains unresolved,” commented principal investigator Dr. Juan F. Iglesias, Lausanne University Hospital (CHUV), Lausanne, Switzerland. “During the earlier BIOSCIENCE trial, Orsiro was associated with a reduced risk of the primary endpoint, target lesion failure (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.”

BIOSCIENCE is the largest investigator-initiated study to date evaluating the safety and efficacy of Orsiro, a bioabsorbable polymer DES, in comparison to the durable polymer Xience Xpedition DES. Results from the multi-center, randomized, controlled non-inferiority trial were first published in The Lancet. A subanalysis of 407 STEMI patients revealed that Orsiro was associated with better clinical outcomes than Xience Prime/Xpedition for this indication. At one year, BIOSCIENCE’s primary endpoint TLF occurred in just seven (3.3 percent) STEMI patients treated with Orsiro compared with 17 (8.7 percent) patients treated with the durable polymer DES.

The investigator-initiated, international multi-center BIOSTEMI superiority trial is currently in the process of enrolling 1,250 patients at 16 study centers in Switzerland and Italy. STEMI patients will be randomized for treatment with either Orsiro or Xience Xpedition. BIOSTEMI’s primary endpoint is TLF at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization (CD-TLR). All patients will be followed for up to five years.

“Following the extremely promising results seen in the BIOSCIENCE trial’s STEMI subgroup, we intend to prove Orsiro’s far-reaching capabilities with a trial focused on this challenging indication,” stated Dr. Alexander Uhl, Vice President Marketing, Vascular Intervention at BIOTRONIK. “In addition, this trial represents an excellent opportunity to gather vitally important data on a complex patient population. We greatly look forward to the results.”