BioMatrix Flex™ Outperforms Cypher® Select™ At Five Years

In short

Biosensors International has announced five-year results from the LEADERS trial, showing improved long-term clinical outcomes for BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, compared to Cypher® Select™, Johnson & Johnson’s sirolimus-eluting stent system with a durable polymer.

BioMatrix Flex significantly reduced the risk of clinical events compared with Cypher Select and demonstrated a reduced risk of very late stent thrombosis (VLST).


It’s TCT congress time, in case anyone hadn’t noticed the flurry of press release activity.  Not wanting to miss out on the opportunity, Biosensors International is trumpeting the final report from its LEADERS  study which was presented yesterday by Professor Patrick W. Serruys, Erasmus Medical Center, Rotterdam, The Netherlands, at the event.

LEADERS has achieved a series of notable firsts: it was the first head-to-head randomised clinical study (RCT) between two limus-eluting stents; the first RCT between two stents to involve an “all-comers” patient population; and the first RCT between two stents to be independently monitored and assessed by its investigators.

Results at five years demonstrated that the relative risk of MACE (Major Adverse Cardiac Events) was 17% lower in patients treated with BioMatrix Flex than in those treated with Cypher Select (22.3% vs. 26.1%; Psup = 0.071). During the one to five year period, BioMatrix Flex was also associated with a significant 74% reduction in definite VLST compared with Cypher Select (0.66% vs. 2.5%; Psup = 0.003). The study had an excellent follow-up rate of 96.5%.

Investigator comments

“As a result of LEADERS, most drug-eluting stents currently being developed use biodegradable polymer technology”, commented Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. “BioMatrix was one of the pioneering stent platforms to use a biodegradable polymer applied to the abluminal surface only.”

Company comments

“Results from LEADERS have helped patients to benefit from our superior technology, as this was the first study to actually show that a drug-eluting stent with a biodegradable polymer was better than one with a durable polymer”, added Jeffrey B. Jump, President of Biosensors’ Cardiovascular Business Unit.

Source: Biosensors International