Primary percutaneous coronary interventions (PCIs) have been demonstrated to be the routine strategy for patients presenting with an acute myocardial infarction (AMI), reducing rates of re-infarction and stroke and improving survival rates. Drug-eluting stents have been shown to be effective in reducing restenosis and re-occlusion compared to bare metal stents in patients with coronary artery diseases. Nevertheless, concerns still exist about the relative safety and efficacy of drug-eluting stents in particularly challenging subsets of patients, such as patients with AMI. Patients with a recognised myocardial infarction are patients at the highest risk of further cardiac disease complications, such as another heart attack, sudden death, angina pectoris, heart failure or stroke. AMI patients show increased mortality rates owing to an increased incidence of stent thrombosis, these concerns may be related to the delayed endothelialisation of some drug-eluting stent platforms.
To meet these important challenges, Sorin has developed a unique tacrolimus-eluting Carbostent, Janus, and is now launching an enhanced next-generation stent with significantly improved deliverability - the Janus Flex.
The unique features of Janus Flex include a polymer-free platform, integral Carbofilm coating, the endothelium-friendly drug tacrolimus, and revolutionary reservoirs that allow the drug to be delivered precisely and homogeneously to the vessel wall. Sorin has also designed a new delivery system that offers improved conformability in challenging anatomies. The proven biocompatibility and thrombo-resistance of the Carbofilm-coated stent surface could reduce the thrombosis risk and potentially play an important role in the early endothelialisation of the stent .
Tacrolimus, a 'smart drug', is a proven cytostatic that selectively inhibits smooth muscle cell proliferation and migration while permitting enhanced re-endothelialisation.
The bio-compatibility and thrombo-resistance of the Carbofilm coating in the setting of AMI patients has been demonstrated in, among others, the ACE (Abciximab and Carbostent Evaluation) trial. The objective of the ACE trial was to compare primary coronary stenting, with or without abciximab as adjunctive therapy, in patients with AMI. Coronary stenting with Sorin's Carbostent was performed in a total of 400 patients. Important results from the ACE trial show that Sorin's Carbostent was safe end effective, with low mortality and re-infarction rates at 30 days and six months follow-up.
Latest evidence from e-Janus
E-Janus is a multicenter prospective registry based on electronic case report forms assessing the clinical performance of the Janus Carbostent in the treatment of 'real world' populations. The e-Janus registry has currently enrolled more than 2,400 unselected patients in over 75 European centres, including some patients with complex clinical presentations such as diabetes, multi-vessel disease, complex lesions and AMI. The interim data from e-Janus will be presented at the Joint Interventional Meeting (JIM) in Rome (February 16-18), and will demonstrate strong clinical benefits of Janus in real world populations and excellent outcomes in AMI patients. These data will be presented by Dr Koolen (Eindhoven), principal investigator. of the e-Janus registry, on Friday 17th of February at JIM.
The Janus Flex tacrolimus-eluting Carbostent is the only polymer-free drug-eluting stent combining a unique targeted drug delivery system with best-in-class deliverability, bringing the right balance between excellent safety profile and long-term clinical efficacy for patients. The proven efficacy of Carbofilm coating together with the 'smart drug' tacrolimus ensure an early endothelialisation of the stent, therefore decreasing any risks of thrombogenicity. This leads to very low stent thrombosis rates, providing the solution of choice for your AMI patients.
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