The final long-term results of the e-BioMatrix registry, which was presented at EuroPCR 2015 (19–22 May, Paris, France) by David Hildick-Smith (Sussex Cardiac Centre, Brighton, UK), have confirmed that the family of BioMatrix drug-eluting stents are safe and efficacious. The results are from 5,470 real-world patients who were followed for more than three years.
Initiated in March 2008, e-BioMatrix is a large, prospective, multicentre, single-arm observational registry designed to assess the reproducibility of the safety and efficacy profile of the BioMatrix drug-eluting stent family, as seen in LEADERS (an all-comers randomised clinical trial in “real-world” patients), across a broader range of centres over the long term. More than five thousand patients were enrolled at 57 different centres, and 4,903 patients (89.6%) were followed-up out to three years.
The primary endpoint for the registry was the rate of major adverse cardiac events (MACE) at 12 months. The key secondary endpoints included the rates of MACE and stent thrombosis at three years. The rationale of the registry was to determine outcomes of the biolimus A9-eluting stent in routine clinical use across a broad selection of centres, with a focus on stent thrombosis and bleeding.
The MACE rate at three years was 9% (cardiac death 2.1%; myocardial infarction 3.2%; clinically-indicated target vessel revascularisation 5.6%). The incidence of definite or probable stent thrombosis was 0.9%, and of major bleeding was 2.5%. Dual antiplatelet therapy was given to all patients for a minimum of six months, with a recommendation for up to 12 months.
A broad range of inclusion criteria have ensured that e-BioMatrix is a “real-world” registry: patients only had to be 18 years old or older and have been treated with one of the BioMatrix family of drug-eluting stents of any size in any vessel. Multiple stents were allowed. There were no limitations on the number of treated lesions, vessels, or lesion length.
Principal investigator Philip Urban (Hôpital de la Tour, Geneva, Switzerland), says: “The very low rate of definite and probable stent thrombosis confirm that this sequela, while still associated with very significant morbidity and mortality, is no longer a frequent problem. Shorter DAPT courses could be expected to be associated with a decreased incidence of major bleeding.”
The registry involved patients treated with either BioMatrix or BioMatrix Flex. Both drug-eluting stents incorporate Biolimus A9, which is a highly lipophilic antirestenotic drug developed by Biosensors specifically for use with stents, together with a Biosensors-designed abluminal biodegradable polymer coating, which fully degrades into carbon dioxide and water after six to nine months as it releases BA9.