This article is more than 5 years old. Information may no longer be current.
LEADERS FREE: Polymer-free drug-coated stent safe, effective with oral anticoagulation
In patients requiring long-term oral anticoagulation, a drug-coated stent was more effective at 2 years compared with bare-metal stents, according to the results of the LEADERS FREE oral anticoagulation substudy.
The main results of the LEADERS FREE study showed that the polymer-free drug-coated stent (BioFreedom, Biosensors Europe) was superior to BMS in patients at high bleeding risk.
In a prespecified analysis, Didier Carrié, MD, from the Center Hospitalier Universitaire in Toulouse, France, and colleagues analyzed 879 patients from LEADERS FREE trial who planned to continue oral anticoagulation treatment after PCI.
The double-blind, randomized study assigned patients to the polymer-free drug-coated stent or a BMS (Gazelle, Biosensors Interventional Technologies).
Patients were given either clopidogrel plus aspirin or clopidogrel alone for 1 month, followed by long-term single-antiplatelet therapy.
The primary safety endpoint was a composite of cardiac death, MI and stent thrombosis. The primary efficacy endpoint was incidence of clinically driven target lesion revascularization.
Carrié and colleagues found similar baseline characteristics among the groups; 78.8% of the cohort had a history of atrial fibrillation and 21% presented with ACS.
At 2 years, clinically driven TLR was 7.5% in the drug-coated stent group vs. 11.2% in the BMS group (HR = 0.63; 95% CI, 0.4-1.01).
The safety endpoint was reached by 14.4% of patients in the drug-coated stent group and 15% of the BMS group and major bleeding event rates were 10.7% and 12.9%, respectively, at 2 years. These results were not statistically significant, the researchers wrote.
“Although this [drug-coated stent] is thus the only active stent with a proven track record for a single month of DAPT in orally anticoagulated patients, the high incidence of major bleeding suggests that further work is needed to optimize the care of these high-risk patients,” Carrié and colleagues wrote. – by Dave Quaile
Disclosures: The LEADERS FREE trial was funded by Biosensors Europe. Carrié reports no relevant financial disclosures. One author reports being employed by Biosensors and another reports consulting for Biosensors.