Boston Scientific has received European approval to update the directions for use (DFU) labeling for Promus Element and Promus Element Plus Coronary Stent Systems to include three-month dual anti-platelet therapy (DAPT).
This language outlines a minimum duration of three months of DAPT for certain patients who may need to interrupt or discontinue the medication for a variety of reasons and supports the strong safety profile for Promus Element and Promus Element Plus stents. The label change will be introduced in CE mark countries.
“Boston Scientific is pleased to provide this additional guidance in our labeling,” said Keith D Dawkins, executive vice president and global chief medical officer for Boston Scientific. “However, it remains important to consider the major clinical society guidelines for DAPT post-stent implantation for durable polymer stents.”
Current European of Cardiology (ESC) guidelines recommend nine to twelve months of DAPT, with a minimum of six months for those who received a drug-eluting stent (DES). The American Heart Association (AHA) and American College of Cardiology (ACC) recommend up to twelve months of DAPT for DES post-stent implantation.