Medtronic's RESOLUTE Program Shows No Increased Safety Risk in Interrupting DAPT at 1 Month After Stent Implantation

March 11, 2013—Medtronic, Inc. (Minneapolis, MN) announced that patients with coronary artery disease who received the company's Resolute drug-eluting stent as participants in one of several clinical studies and who interrupted or discontinued their dual-antiplatelet therapy (DAPT) after 1 month following the implantation procedure showed no increased safety risk through 1 year of follow-up.

According to Medtronic's press release, the finding comes from a new analysis of nearly 5,000 patients from the global RESOLUTE clinical program, which included two large studies that enrolled “all comers.” Ajay Kirtane, MD, presented the analysis at the 62nd annual scientific session of the American College of Cardiology in San Francisco, California. Dr. Kirtane is Chief Academic Officer and Director of the interventional cardiology fellowship program at New York-Presbyterian Hospital/Columbia University Medical Center in New York, New York.

In the company's announcement, Dr. Kirtane commented, “While most physicians would expect patients who interrupted their DAPT after as few as 30 days following drug-eluting stent implantation to be at a much greater risk for stent thrombosis, this was not observed with the Resolute stent. These data should be very reassuring to physicians, as well as to patients in whom this newer-generation stent is implanted.”

As part of the new analysis, the investigators also examined patients who interrupted their DAPT after at least 1 month following the implantation procedure for a period of more than 14 days, by which time normal platelet function typically resumes. These patients—who constituted the vast majority of those who interrupted their DAPT after 1 month— experienced no instances of stent thrombosis (0.0%) through 1 year of follow-up.

Medtronic recently announced that based on this analysis, the company had received approval from European regulators to update the CE Mark labeling for the Resolute Integrity drug-eluting stent with new language related to 1-month DAPT duration. This labeling update applies to product distributed in countries that accept the CE Mark. It does not apply to product distributed outside this region, including the United States, advised Medtronic.

In other data presented at the ACC meeting, the RESOLUTE Pooled Safety update, which includes data on all 5,130 patients who received a Resolute stent as participants in the program, showed a consistently low rate of stent thrombosis of 1.1% out to 3 years after implantation; in the RESOLUTE US study, which enrolled 1,402 patients in the United States, the stent thrombosis rate out to 3 years was 0.37%, stated Medtronic.