LEADERS FREE Substudy Presented for Biosensors' Biofreedom Drug-Coated Stent in ACS Patients

May 31, 2016—Results from the LEADERS FREE substudy of the polymer-free Biofreedom biolimus-A9 (BA9) drug-coated stent (Biosensors International Group, Ltd) in acute coronary syndromes (ACS) were reported for the first time at the EuroPCR 2016 conference held May 17–20 in Paris, France.

According to the EuroPCR press release, the substudy results demonstrated that patients with ACS who are at high risk for bleeding have significantly lower rates of target lesion revascularization (TLR) and fewer adverse events after undergoing percutaneous coronary intervention (PCI) with the Biofreedom device than with those receiving a bare-metal stent. The polymer-free and carrier-free Biofreedom drug-coated stent transfers BA9 into the blood vessel wall over a 1-month period. BA9, also know as umirolimus, is a highly lipophilic analogue of sirolimus.

The study was led by Christoph Naber, MD, from the Contilia Heart and Vascular Center in Essen, Germany. In the press release, Dr. Naber commented, “Patients with acute coronary syndromes have a high risk of bleeding after PCI because of the medication they are taking, but they have never previously been systematically studied.”

At EuroPCR, Dr. Naber reported new results from a prespecified substudy of 659 patients with ACS. The substudy included 105 patients with ST-segment elevation myocardial infarction (STEMI) and 554 patients with non-STEMI. The patients were randomized to receive either the Biofreedom drug-coated stent or a bare-metal stent. All patients received 1 month of dual-antiplatelet therapy (DAPT).

At 12-month follow-up, the patients receiving the Biofreedom stent had less than half the rate of clinically driven TLR compared to those patients receiving a bare-metal stent (3.92% vs 8.96%; P = .009). They also had a significantly lower risk of adverse events, which was a composite of cardiac death, myocardial infarction, and stent thrombosis (6.92% vs 9.32%; P = .049). 

Dr. Naber stated, “The most important take-home message is that using a BA9-coated stent plus 1 month of DAPT not only improves the efficacy of PCI in patients with ACS and high risk of bleeding compared to use of a bare-metal stent but also increases safety, with less cardiac death, myocardial infarction and stent thrombosis.” He continued, “Current guidelines may need to be revised and bare-metal stents can no longer be recommended for these patients. Given the lack of data for second-generation drug-eluting stents with shortened DAPT, the polymer-free BA9-coated stent is currently the device with the strongest evidence supporting its use in this group of patients.” 

In October 2015, the LEADERS FREE study was presented and simultaneously published in The New England Journal of Medicine (2015;373:2038–2047). The total study population included 2,466 patients. Results showed a 50% lower rate of TLR in patients randomized to the drug-coated stent compared to those receiving the bare-metal stent and a 1-month course of DAPT (hazard ratio 0.5; P < .001). 

Commenting on the new results from the ACS substudy, the EuroPCR discussant Thomas Cuisset, MD, stated in the announcement, “The benefit of the drug-coated stent over the bare-metal stent was even greater in patients with ACS than in the study population as a whole. The information from this substudy is key because this specific population has not been included in previous clinical studies and, until now, treating these patients was like working in a ‘data-free’ zone.” For the future, Dr. Cuisset suggests, “The respective roles of new-generation drug-eluting stents, drug-coated stents, and potentially fully resorbable devices will require further investigation. Also, the optimal duration of DAPT used with the drug-coated stent in this study should probably not be extrapolated to other populations, including those at low bleeding risk.” Dr. Cuisset is from University Hospital, La Timone in Marseille, France.