On the 21 May, at EuroPCR, Paris, France, new registry data confirmed that the BioMatrix drug-eluting stent family is safe over a 12-month period in a “real-world” population of 5559 patients.
Initiated in March 2008, e-BioMatrix is a prospective, multicentre, observational registry. e-BioMatrix, according to a release, was designed to assess the reproducibility of the long term results from LEADERS, Biosensors’ randomised clinical trial, but in a broader range of centres representing “real world” patients. Data was pooled from two different registries: e-BioMatrix PMS, involving 1106 patients, and e-BioMatrix PMR, involving 4453 patients. The primary endpoint for the registry was MACE (a composite of cardiac death, myocardial infarction and clinically-indicated target vessel revascularisation) at 12 months.
Of the 5559 patients studied, 5327 patients (96%) were followed up at 12-months. Only 239 (4.3%) were reported as experiencing a primary endpoint event. A very low rate of definite/probable stent thrombosis was observed (0.6%), with most incidences occurring in the first month, while low rates of major bleeding continued out to 12 months, with an incidence of 1.6%.
A broad range of inclusion criteria have ensured that e-BioMatrix is a “real-world” registry: Patients just had to be a minimum of 18 years old and have been treated with one of the BioMatrix family of drug-eluting stent (any size, any vessel). Multiple stents were allowed. There were no limitations on the number of treated lesions, vessels, or lesion length.
“The findings of this real-world registry are very important in helping us to learn more about the safety aspects of drug-eluting stents. The very low 12-month rate of definite and probable stent thrombosis confirm that stent thrombosis, while still associated with significant mortality, is no longer a frequent problem”, commented principle investigator Philip Urban, Hôpital de la Tour, Geneva, Switzerland. “Shorter dual antiplatelet therapy 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 incorporated Biolimus A9, a highly lipophilic anti-restenotic 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 Biolimus A9.