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news.Biosensors International Group has announced that a next-generation drug-eluting stent developed by the company has demonstrated equal safety and efficacy as compared to Johnson & Johnson's drug-eluting stent, Cypher Select, based upon nine-month clinical and angiographic follow-up data.
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Biosensors said that Leaders is the first head-to-head randomized study between the two drug-eluting stent systems (DES) in a ‘real world, all comers’ population using clinical results as its primary endpoint.
This multi-center European study randomized 1,707 patients eligible for percutaneous coronary intervention (PCI) for symptomatic coronary disease to receive either a Biosensors Biolimus-eluting DES with an abluminal biodegradable polymer coating, or a Cypher Sirolimus-eluting DES with a durable polymer.
In total, 2,472 coronary lesions were treated. Inclusion criteria were broad, reflecting routine clinical practice, without limitations regarding type of coronary vessel, lesion length or number of treated lesions. Patient conditions known as ‘off-label indications’, including acute coronary syndromes, saphenous vein grafts and previously treated lesions were also included in the trial.
The primary endpoint of the study was non-inferiority of the composite of cardiac death, myocardial infarction, and clinically driven target vessel revascularization at nine months follow-up. In addition, 25% of all patients were randomly assigned to undergo angiographic follow-up at nine months. The principal endpoint of the pre-specified angiographic sub-group was in-stent percent diameter stenosis at nine months.
During the first nine months, 9.2% of patients receiving the Biosensors DES, and 10.5% of patients given the Cypher DES experienced a clinical adverse event that could be included in the primary composite endpoint, thus demonstrating that the Biosensors stent was non-inferior to the Cypher stent. A favorable trend towards the Biosensors stent was non-significant at the nine months follow-up endpoint.
As anticipated, clinical event rates were higher in Leaders compared with previous DES trials performed in patients with only on-label indications, because the Leaders trial design permitted inclusion of any patient eligible for PCI, said Biosensors. As a result, rates of death, myocardial infarction and stent thrombosis were similar for both stent types, but were 2.6% higher when compared to the earlier, less inclusive trials.