Credit: Sage Ross
WASHINGTON, DC—Six weeks of triple anticoagulant therapy may be sufficient in patients who have received a drug-eluting stent.
Results of the ISAR-TRIPLE trial revealed no significant differences in net clinical outcomes for patients who received 6 weeks of triple anticoagulant therapy and those who received 6 months of the therapy.
Nikolaus Sarafoff, MD, of Deutsches Herzzentrum Munich and Klinikum der Universität Munich in Germany, presented these results at TCT 2014.
“The shortening of triple therapy neither reduced the incidence of TIMI major bleeding nor increased the incidence of the composite of ischemic events,” Dr Sarafoff said. “These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy.”
For the ISAR-TRIPLE trial, Dr Sarafoff and his colleagues randomized 614 patients in a 1:1 fashion to either 6 weeks or 6 months of clopidogrel therapy, in addition to aspirin plus an oral anticoagulant (phenprocoumon or warfarin).
The primary endpoint was a composite of death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months.
As secondary endpoints, the researchers assessed TIMI major bleeding separately from a composite endpoint of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke.
The primary endpoint occurred in 9.8% of patients in the 6-week treatment group and 8.8% of patients in the 6-month group (P=0.63.)
The composite of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke occurred at a similar rate in both the 6-week and 6-month groups—4.0% and 4.3%, respectively (P=0.87).
And the same was true for TIMI major bleeding, which occurred in 5.3% of patients in the 6-week group and 4.0% in the 6-month group (P=0.44).
This trial was funded by Deutsches Herzzentrum München. Dr Sarafoff reported fees for lectures or traveling from Lilly/Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare, Boston Scientific, Biotronik, and Medtronic.