LEADERS FREE: Drug-Coated Stent Bests BMS in High-Risk PCI Patients

Among patients at high risk for bleeding, the use of a drug-coated stent (DCS) appears to be both safer and more effective than bare-metal stenting when the devices are paired with 1 month of dual antiplatelet therapy. The findings, from the LEADERS FREE trial, were presented yesterday at TCT 2015 and simultaneously published in the New England Journal of Medicine.

For the study, Philip M. Urban, MD, of LaTour Hospital, in Geneva, Switzerland, and colleagues randomized 2,466 high-risk patients (mean age 75.7 years; 30% women) scheduled to receive PCI to implantation with the BioFreedom DCS (Biosensors International; n = 1,239) or the Gazelle BMS (Biosensors International; n = 1,227) plus 1 month of DAPT. The novel DCS is a polymer-free, stainless steel stent designed to hold the drug in abluminal surface structures, Urban explained, adding that the study population is one that is not typically included in drug and device trials.

An unusual population

In a modified ITT analysis, patients in the DCS arm had a much lower rate of the primary efficacy endpoint of clinically-driven target lesion revascularization at 1 year. Additionally, BMS use was associated with higher rates of all secondary efficacy endpoints including any TLR and any revascularization.

Additionally, although researchers only predicted the DCS to prove equally safe as BMS, rates of the primary composite safety endpoint (cardiac death, MI, and definite/probable stent thrombosis) at 1 year were substantially lower with DCS compared with BMS (9.4% vs 12.9%; P = .005 for superiority). Safety was driven by a lower rate of MI in the DCS arm than in BMS (6.1% vs. 8.9%; P = .01), since stent thrombosis rates were similar in both cohorts (2% vs 2.2%; P = .70).

In a subgroup analysis of the safety endpoint, outcomes were consistent with the main results apart from a larger treatment effect with DCS seen in patients presenting with ACS (P = .04). Moreover, the DCS was more effective than the BMS in patients without renal failure at admission; with a Crusade score ≤ 35; and without anemia, transfusion or bleeding leading to hospitalization.

Bleeding outcomes, including BARC 3-5 bleeding, were similar in both study groups over 1 year.

Panelist Eric D. Peterson, MD, of the Duke Clinical Research Institute, in Durham, N.C., said studies too often leave out the high-risk patients typically seen in clinical practice. Studies like LEADERS FREE that target older patients at higher risk are “exactly what we should be doing,” he said.


  • Urban reports receiving grant/research support from Biosensors Europe and consultant/honoraria fees from Abbott Vascular, Edwards Lifesciences and Terumo Corporation.