Why the study?
Do polymer-free drug-coated stents improve safety and efficacy compared to bare metal stents in patients with high bleeding risk?
Do polymer-free drug-coated stents improve safety and efficacy compared to bare metal stents in patients with high bleeding risk?
Polymer-free drug-coated stents maintain safety and efficacy benefits over bare metal stents at 2 years in high bleeding risk patients.
DCS remains preferable to BMS in high bleeding risk patients through 2 years; extends prior RCT data to longer-term follow-up.
Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180).
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Garot et al. (2016) studied this question.
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