May 20, 2011 – e-BioMatrix post-marketing surveillance (PMS) registry information presented at EuroPCR 2011 has confirmed that BioMatrix, Biosensors’ Biolimus A9-eluting stent system with abluminal bioresorbable polymer, is safe over a 12-month period in a “real-world” patient population.
The e-BioMatrix PMS Registry, initiated in March 2008, is a prospective, multi-center, observational registry to assess the outcomes of over 1,000 “real-world” patients across nine European study sites over a five-year period. Enrollment was completed in September 2009. All patients are being comprehensively monitored, including for baseline information, index hospitalization and the patient file until last reported cardiac-related event. The primary endpoint of the registry was MACE (a composite of cardiac death, MI and clinically-driven TVR) at 12 months. Of the 1102 patients studied over this period, 74 (6.7%) experienced a clinical adverse event that could be included in the primary endpoint according to the independent Critical Events Committee. The registry will also examine a range of secondary endpoints, including primary and stent thrombosis over several periods; MACE at intervals up to five years; and death and MI rates for up to five years.
A broad range of inclusion criteria have ensured that e-BioMatrix is a “real-world” registry: patients have had to be at least 18 years old; need treatment with a DES; and have one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents. There have been no limitations on the number of treated lesions, vessels, or lesion length.
“These registry findings provide further reassurance on the safety of a biolimus-eluting stent with biodegradable polymer in a wide range of patient types requiring PCI that we routinely see in our daily practice,” said principal investigator Dr. Philip Urban, La Tour Hospital, Geneva, Switzerland. “The results are especially reputable due to the high levels of follow-up that have been achieved, with 97.6 percent at one year.”
A similar registry to e-BioMatrix PMS, the e-BioMatrix Post-Marketing Registry (PMR), was initiated at the same time, involving up to 4,800 patients. The protocols of the two studies are identical, with e-BioMatrix PMR monitoring for reported cardiac-related events only. Enrollment for this second registry is due to be completed by October 2011.
The PMS registry solely involved patients given the original BioMatrix, whereas the PMR involved patients given both BioMatrix and BioMatrix Flex. Introduced in May 2010, BioMatrix Flex incorporates an improved mechanical platform for enhanced deliverability, whilst retaining the Biosensors-developed abluminally-coated biodegradable polymer and Biolimus A9, an anti-restenotic drug developed by Biosensors exclusively for use with drug-eluting stents, as used in the original BioMatrix stent system.
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