Orsiro drug-eluting stents (DES) outperformed the current standard device for percutaneous coronary intervention (PCI) in a randomized international trial, according to a presentation from the European Society of Cardiology Congress.
In a study of 1,334 patients at one year follow-up, Biotronik’s Orsiro DES showed a 6.2 percent target lesion failure (TLF) rate compared to 9.6 percent for Abbott Vascular’s Xience DES.
Orsiro is an ultrathin, bioresorbable polymer sirolimus-eluting stent, while Xience is a durable polymer everolimus-eluting stent.
The bioresorbable polymer stent also demonstrated lower rates for target vessel MI (4.7 to 8.3 percent), clinically driven target lesion revascularization (2.0 to 2.4 percent) and definite/probable stent thrombosis (0.5 to 0.7 percent).
Biotronik said the current trial is the first large, randomized study to indicate improved outcomes for any DES over Xience.
"Orsiro's rate of TLF shows an unprecedented improvement in DES outcomes compared with a control stent that has served as a standard in interventional cardiology," U.S. principal investigator David Kandzari, MD, with the Piedmont Heart Institute in Atlanta, said in a statement.
"Orsiro also notably has exceptional deliverability that is essential for PCI procedures. We believe Orsiro's ultrathin 60 micron struts, bioresorbable polymer and proven antiproliferative drug are the key elements to its superior performance."
Orsiro is commercially available in more than 100 countries, but is still under an investigative device exemption in the United States. The results of the trial could help the bioresorbable polymer stent enter the U.S. marketplace, Biotronik president Marlou Janssen said in a statement.