At Biosensors International, innovation and clinical evidence is our driving force. We don’t just bring innovative and unique coronary stents to the market, we conduct robust landmark clinical trials to provide physicians with the confidence they need when choosing a Biosensors stent for their patient’s revascularization procedure.
The Biosensors clinical program is optimized to assess the safety and efficacy of our products through innovative and challenging clinical trials. We work in partnership with the medical community and the world’s leading clinical investigators, to prove our products are safe and efficacious, allowing physicians who implant them to trust in Evidence Based Medicine.
LEADERS FREE1 was the first clinical trial to evaluate a one-month ultra-short course of DAPT in High Bleeding Risk (HBR) patients with mixed comorbidities. Superior safety and efficacy over the previous gold standard treatment was demonstrated. The pre-specified LEADERS FREE subgroups add to the wealth of clinical evidence, the LEADERS FREE pre-specified ACS subgroup2 showed a reduction in cardiac death for the patients treated with BioFreedom vs the control BMS.
In 2018, LEADERS FREE II will be the first clinical trial with results on a one-month ultra-short course of DAPT post PCI in HBR patients in the USA.
LEADERS3 was published in the Lancet in 2008. This was the first clinical trial to evaluate a genuine all comer patient population. The study demonstrated that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. The results were confirmed up to 5-years, with a trend towards a reduction in stent thrombosis4. The first continued, TCT 2012 5-year follow-up of LEADERS presented the longest follow-up of an all comers trial to date. The LEADERS AMI subgroup5 demonstrated for the first time a reduction in cardiac death vs SES in STEMI patients.