The LEADERS FREE study showed that a biolimus A9-coated polymer-free stent was superior to a conventional stent in terms of safety and efficacy in patients who received dual antiplatelet therapy for only a month due to their high risk for bleeding.
In this substudy, researchers analyzed 667 patients enrolled in the original LEADERS FREE trial who met certain requirements for complex angioplasty: total stent length >60 mm, 3-vessel lesions, 3 or more implanted stents, bifurcation lesions requiring 2 stents, total occlusions, restenosis, or lesions in saphenous vein grafts. All these high-risk patients were randomized to biolimus A9-coated polymer-free stent or conventional stent. The risk of bleeding for these patients who had undergone complex angioplasty was even higher than the mean risk for the whole study population.
The biolimus-eluting stent showed benefit both in terms of safety (16.2% vs. 21.7%; hazard ratio [HR]: 0.70 [0.49-0.99]; p < 0.05) and efficacy (10.8% vs. 18.1%; HR: 0.54 [0.35-0.83]; p < 0.005). However, for the 1746 patients who had undergone complex angioplasty, the relative difference in efficacy was even higher than for the general population (5.3% vs. 9.9%; HR: 0.52 [0.36-0.75]; p < 0.001), while safety was similar to that shown by conventional stents (11.1% vs. 12.6%).
Original title: LEADERS FREE: Complex PCI for Patients at High Bleeding Risk – Two Year Outcome of a Substudy.
Presenter: Philip Urban.
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