Biotronik said today it enrolled the 1st patient in its BiostemI trial looking to compare the safety and efficacy of its Orsiro hybrid drug-eluting stent with Abbott‘s (NYSE:ABT) Xience Xpedition in treating ST-segment elevation myocardial infarction.
The company is touting the trial as the largest investigator-initiated study pitting the Orsiro stent against the Xience Xpedition. The randomized, multi-center trial is slated to enroll 1,250 patients at 16 centers in Switzerland and Italy, Biotronik said.
“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. 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,” principal investigator Dr. Juan Iglesias of Switzerland’s Lausanne University Hospital said in a prepared statement.
Patients in the trial will be randomized to treatment with either the Orsiro or Xience Xpedition, with a 12-month primary endpoint defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization. Patients in the trial will be followed for up to 5 years, Biotronik said.
“Following the extremely promising results seen in the Bioscience trial’s Stem1 subgroup, we intend to prove Orsiro’s far-reaching capabilities with a trial focused on this challenging indication. 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,” vascular intervention biz marketing veep Dr. Alexander Uhl said in a press release.
Earlier this month, Biotronik said it won FDA premarket approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, which is designed to be compatible with diagnostic magnetic resonance imaging scans.
The Iperia line of devices also features remote monitoring with daily automatic transmission and closed loop stimulation designed to adapt heart rate in response to physiological demands, Biotronik said.
