SAN FRANCISCO — A polymer-free biolimus-coated stent demonstrated better safety and efficacy than a bare-metal stent when used with a 1-month course of dual antiplatelet therapy, according to data presented at the annual TCT Scientific Symposium.
“LEADERS FREE is the first randomized clinical trial entirely dedicated to patients with a high risk for bleeding,” Philip M. Urban, MD, director of interventional cardiology, La Tour Hospital, Geneva, said in a presentation. “Such patients are often excluded from stent and drug trials, but they constitute a rapidly growing proportion of PCI candidates, and they do suffer a very high event rate.”
Urban and colleagues conducted a double blind trial that randomly assigned 2,466 patients (mean age, 75.7 years) with elevated bleeding risk who underwent PCI with a polymer-free and carrier-free drug-coated stent (BioFreedom, Biosensors International) or a BMS (Gazelle, Biosensors International).
The polymer-free stent transfers the sirolimus-analogue biolimus A9 into the vessel wall; the device already has CE mark approval and received conditional approval to conduct a clinical trial in the United States to gather additional safety and efficacy data.
Enrolled patients had more comorbidities, including renal failure, cancer, need for major surgery or anticoagulation, than patients generally included in a stent trial.
All patients received DAPT for 1 month. The investigators sought composite of CV death, MI or stent thrombosis as the primary safety endpoint, with tests for both noninferiority and superiority. Clinically driven target lesion revascularization served as the primary efficacy endpoint.
At a follow-up of 390 days, the primary safety endpoint occurred in only 112 patients (9.4%) with a drug-coated stent compared with 154 patients (12.9%) with a BMS (risk difference, –3.6 percentage points; 95% CI, –6.1 to –1). This translated to an HR of 0.71 (95% CI, 0.56-0.91). The results met both noninferiority (P < .0001) and superiority (P = .005).
The primary efficacy endpoint occurred in 59 patients (5.1%) with a drug-coated stent compared with 113 patients (9.8%) with a BMS (risk difference, –4.8 percentage points; 95% CI, –6.9 to –2.6). This translated to an HR of 0.5 (95% CI, 0.37-0.69).
“Together with a 1-month only DAPT course, the use of a [biolimus A9 drug-coated stent] was both significantly safer and more effective than a control BMS in patients with a high risk for bleeding,” Urban said.
Eric D. Peterson, MD, co-moderator for the session and editor for JAMA Cardiology, called the paper “phenomenal” and lauded its “impressive” efficacy and safety results.
“We too often leave out those groups that we see too commonly in routine clinical practice,” he said. “Actually targeting the crowd to older individuals at high risk is exactly what we should be doing.”
Gregg W. Stone, MD, TCT co-director and session co-moderator, said looking at subgroups in the study will be important moving forward.
“We know that longer DAPT tends to prevent [MI] not only from the sent-side but from the non-stent side,” said Stone, who also is a Cardiology Today’s Intervention Editorial Board member. “We need to also dissect which of these patients can only tolerate 1 month of DAPT and which might be able to tolerate longer-term DAPT.” – by Allegra Tiver
Urban P, et al. LEADERS FREE: A prospective, double blind randomized trial of a polymer-free biolimus-eluting stent vs. bare-metal stents in patients with coronary artery disease at high risk for bleeding. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Urban P, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1503943.
Disclosure: Urban reports multiple financial relationships in consulting and research for Abbott Vascular, Biosensors Europe, Edwards Lifesciences and Terumo.