It’s all Medtronic today, as it announces receipt of CE mark approval to update the labelling for its Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy (DAPT), the shortest minimum duration referenced on the label for any device of its kind.
Reducing the time required for post-implantation administration of DAPT therapy is something of a holy grail for cardiologists and therefore stent companies. As a bit of background reading, Hong Kong medtech company OrbusNeich looks like it is claiming the shortest DAPT requirement with clinical studies suggesting no difference in stent thrombosis in the event of withdrawal of therapy after only fifteen days. Boston Scientific is making noises along similar lines with its Synergy™ Everolimus-Eluting Platinum Chromium Coronary Stent offering. (Notably, OrbusNeich and Boston are in dispute over patent infringement claims relating to certain of Boston’s stents, as reported in February this year, here.)
Dual antiplatelet therapy involves a combination of acetylsalicylic acid (ASA) and a thienopyridine like clopidogrel. While it necessarily reduces the risk of stent thrombosis, long-term use increases the risk of bleeding complications. So demonstrating (and having regulators agree) that your stent works with minimal DAPT is highly desirable.
In this context, the CE mark approval for Medtronic’s newly modified labelling is good news for the company. It now states: “One year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those who interrupted or discontinued DAPT any time after one month. While physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis.”
This labeling update applies to product distributed in countries that accept the CE mark. It does not apply to product distributed beyond these countries, including the United States.
“An independent analysis of data on nearly 5,000 patients from the global RESOLUTE Clinical Program who received a Resolute drug-eluting stent shows that the greatest risk of stent thrombosis due to DAPT interruption is within the first 30 days of the implant procedure,” explained Prof. Sigmund Silber, M.D., director of the Heart Centre at the Isar in Munich, Germany. “It also shows that DAPT interruption after 30 days is associated with a low risk of stent thrombosis and no increased risk for cardiac death or target vessel myocardial infarction.”
Prof. Silber, a member of the ESC 2010 guidelines committee for myocardial revascularization, presented this analysis at TCT 2012, which took place in Miami in October. Ajay Kirtane, M.D., an interventional cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, plans to present additional analysis during ACC.13, which is scheduled to take place in San Francisco from March 9–11.
Source: Medtronic, Inc.