EuroPCR 2017: Two-year follow-up of LEADERS FREE ACS: is there a place left for BMS in ACS?
Reported from EuroPCR 2017, Paris
Although DES has been a preferred option for patients with ACS undergoing percutaneous treatment, the use of BMS may have been considered in special subsets including patients with high bleeding risk.
In the LEADERS FREE trial, BioFreedomTM drug-coated stent (DCS), which is importantly polymer-free, showed better outcome compared with similar BMS, in over 2400 patients with high risk of bleeding, who had been prescribed a one-month DAPT regimen.
Today, two-year results of a sub-study in 622 ACS patients, LEADERS FREE ACS, were made public, that document the benefit of DCS over BMS in patients with high bleeding risk and thus seem to confirm the direction of the main analysis. In patients receiving DCS and one month DAPT, the rate of clinically driven TLR was halved, compared with BMS (5.0 vs. 10.4%, p=0.009). The occurrence of the primary safety endpoint, a composite of cardiac death, MI and stent thrombosis, was also lower in patients with DCS (13.0% vs. 21.5%, p=0.005), with all individual components being numerically lower in the DCS group and the reduction in MI reaching statistical significance.
The observed differences in outcomes, benefiting DCS, were documented in the first year already and were maintained during the second year of follow-up. Based on the these results, the reasoning to use BMS in ACS patients with high risk of bleeding to make possible a very short DAPT duration, seems to become obsolete, considering the increased safety and better efficacy offered by DCS in this setting.