Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study

Christoph K Naber, Philip Urban, Paul J Ong, Mariano Valdes-Chavarri, Alexandre A Abizaid, Stuart J Pocock, Franco Fabbiocchi, Christophe Dubois, Samuel Copt, Samantha Greene, Marie-Claude Morice, LEADERS FREE Investigators, Christoph K Naber, Philip Urban, Paul J Ong, Mariano Valdes-Chavarri, Alexandre A Abizaid, Stuart J Pocock, Franco Fabbiocchi, Christophe Dubois, Samuel Copt, Samantha Greene, Marie-Claude Morice, LEADERS FREE Investigators

Abstract

Aims: Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients.

Methods and results: Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005).

Conclusion: We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.

Keywords: Acute coronary syndrome; Bare-metal stent; Drug-coated stent; High bleeding risk; Percutaneous coronary intervention.

© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Leaders Free ACS flow chart.
Figure 2
Figure 2
Time-to-event curves for the primary efficacy and safety endpoints *primary efficacy endpoint (clinically driven target-lesion revascularization) **primary safety endpoint (cardiac death, myocardial infarction, or definite and probable stent thrombosis).
Figure 3
Figure 3
Forest plot of Leaders Free for the primary efficacy and safety endpoints and components by acute coronary syndrome status.

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