The prospective, randomized LEADERS trial data demonstrate the equivalence of a biolimus A9-eluting stent with a biodegradable polymer versus a sirolimus-eluting stent with a durable polymer.
The results will be presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The study is to be presented by Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center (Rotterdam, Netherlands.)
"We believe that the development of drug-eluting stents with biodegradable polymers is very promising for patients," Dr. Serruys said. "We are confident that the three-year data on LEADERS will continue to show the equivalent safety and efficacy to a stent with a durable polymer observed in the two-year data presented at TCT 2009."
Drug-eluting stents (DES) effectively reduce the rate of target lesion revascularization (TLR) - the rate at which vessels need to be treated again following angioplasty -- compared with bare-metal stents (BMS). Although rates of death or heart attack are similar, there is concern of an increased incidence of very late stent thrombosis (ST), the occurrence of a blood clot associated with drug-eluting stents potentially related to the durable polymer. In the trial, researchers compared a stent that releases biolimus from a biodegradable polymer (BES) which breaks down inside the body into carbon dioxide and water after 6-9 months.
The overall cumulative percentages of MACE up to 24 months were equivalent: 13.0% for BES and 15.4% for SES, including cardiac death (3.2% versus 4.0%), MI (6.4% versus 5.8%), clinically indicated TVR (7.7% versus 8.8%) and definite stent thrombosis (2.2% versus 2.5%). BES was non-inferior to SES up to 24 months of follow-up.
LEADERS follow-up data at 24 months has confirmed that the 9 and 12 months results are robust, with continuing safety and efficacy. A detailed analysis of the 36 month follow-up data will be presented as during the Featured Clinical Research II session at 6:00 PM on Wednesday September 22 in Room 140A at the Washington Convention Center.
The purpose of the LEADERS trial is to compare the safety and efficacy of BES with an established stent platform releasing sirolimus from a durable polymer (SES) in a large scale, all-comers, non-inferiority trial. Earlier reported results from the LEADERS trial have confirmed that the safety and efficacy of the BES as first observed at the trials' primary and secondary endpoints is robust throughout 2 years of follow up.
Once the BES has released its drug and polymer after 6-9 months, the study suggests that it essentially becomes a bare metal stent (BMS) and thus should have a similar long-term safety profile. The purpose of this presentation is to share new data to determine whether a biodegradable polymer coated DES has an improved safety profile over a 1st generation DES with a durable polymer over a 36 month follow up interval in a real world patient population.
LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) is a multi-center, randomized, assessor-blind, non-inferiority trial performed at 10 European interventional cardiology sites in an all comer, "real world" patient population trial without limitation with respect to lesion length, number of treated lesions or vessels as well as clinical indication (chronic stable angina vs. acute coronary syndromes.) 1,707 patients were enrolled and randomly allocated 1:1 to BES or SES. The primary endpoint of the trial was major adverse cardiac events (MACE) as a composite of cardiac death, myocardial infarction (MI), or justified target vessel revascularization (TVR) within 9 months. All patients are to be followed up to 5 years.