A presentation at the ACC, featuring data for nearly 5,000 patients (including “All Comers”) from the Global RESOLUTE clinical programme, indicates that interrupting dual antiplatelet therapy one month after a patient is implanted with a Resolute drug-eluting stent is not associated with an increased safety risk
Ajay Kirtane, chief academic officer and director of the interventional cardiology fellowship program at NewYork-Presbyterian Hospital/Columbia University Medical Center, USA presented the analysis at the 62nd Annual Scientific Session & Expo of the American College of Cardiology (ACC).
He said: “While most physicians would expect patients who interrupted their dual antiplatelet therapy 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.”
According to a company press release, as part of the new analysis, the investigators also examined patients who interrupted their dual antiplatelet therapy after at least one month following the implant procedure for a period of more than 14 days, by which time normal platelet function typically resumes. Interestingly, these patients – who constituted the vast majority of those who interrupted their dual antiplatelet therapy after one month – experienced no instances of stent thrombosis (0.0%) through one year of follow-up.
Based on this analysis, Medtronic recently received approval from European regulators to update the CE mark labelling for the Resolute Integrity drug-eluting stent with new language related to one-month duration of dual antiplatelet therapy. This labelling 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.
Dual antiplatelet therapy guidelines for patients who receive a drug-eluting stent differ by geographic region, but generally recommend daily compliance for six to 12 months. The applicable guidelines are referenced in the country-specific labeling for each device.