The LEADERS FREE trial demonstrated that a polymer-free Biolimus A9-coated stent (BioFreedom™DCS; Biosensors Europe, Morges, Switzerland) is superior to a conventional stent (bare metal stent, BMS) in patients with high bleeding risk treated with only one month of dual antiplatelet therapy.

Now, is this global study outcome applicable in cases of complex lesions with several implanted stents (≥3), bifurcation lesions with 2 stents, total occlusions, long lesions (≥60 mm), several vessels or lesions treated (≥3), restenosis, or even vein grafts?

There is evidence to the contrary dated back a few months (Robert W. Yeh et al. J Am Coll Cardiol 2017;70:2213–23): in a study, patients who had undergone angioplasty in any of these cases experienced more ischemic events and, in turn, benefited from continued dual antiplatelet therapy for 30 months. This reduced the incidence of infarction and stent thrombosis at 2 years.

Read also: Left Main PCI: Despite Auspicious Long-Term Outcomes, Optimal Strategy Still under Discussion.

This LEADERS FREE sub-analysis followed patients during the exact same period of time and used a definition of complex angioplasty that is very similar to that used in Robert W. Yeh’s work. So, can a polymer-free stent radically change outcomes?

The answer is ‘absolutely yes.’ As regards complex lesions, the polymer-free Biolimus A9-coated stent maintained the safety and efficacy already shown compared with BMS.

Among 2466 patients in the global study, about 667 underwent complex angioplasty defined as presence of one or more of the aforementioned characteristics.

Read also: NSAIDs and Risk of Bleeding in Patients with Atrial Fibrillation.

Patients who underwent complex angioplasty were more often elderly and/or male, with acute coronary syndrome, diabetes, renal insufficiency, anemia, and/or multivessel disease.

In complex angioplasty, the polymer-free stent offered greater benefit compared with BMS in terms of safety (16.2% vs. 21.7%; hazard ratio [HR]: 0.70, 0.49 to 0.99; p < 0.05). We should remember that, for the 1746 patients undergoing simple angioplasty, the difference in safety was not significant (11.1% vs. 12.6%; p = NS).

In terms of efficacy, BioFreedom was also superior in complex angioplasty (10.8% vs. 18.1%; HR: 0.54, 0.35 to 0.83; p < 0.005), although not as much as in simple angioplasty (5.3% vs. 9.9%; HR: 0.52, 0.36 to 0.75; p < 0.001).

Original title: Biolimus A9 Polymer-Free Coated Stents in High Bleeding Risk Patients Undergoing Complex PCI: Evidence from the LEADERS FREE Randomized Clinical Trial.

Reference: Janusz Lipiecki et al. EuroIntervention. 2018 Jul 20;14(4):e418-e425.

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