The Resolute Integrity~(TM)drug-elating stent is approved by the US FDA and supported by data of the TWENTE trial

摘要

The zotarolimus-eluting Resolute Integrity~(TM) stent (Medtronic CardioVascular, CA, USA) has received US FDA approval following studies with this device and its direct predecessor - the Resolute stent. The RESOLUTE All Comers trial was the first study to demonstrate noninferiority of the Resolute stent compared with the FDA-approved XIENCE V~R stent (Abbott Vascular, IL, USA). This has now been confirmed in the TWENTE trial. Resolute Integrity may have benefits over alternative drug-eluting stents (DESs) in that it has an indication for diabetes and addresses some difficulties in deliverability. It is hypothesized that the stent is effective for the treatment of diabetic patients due to its long-term (6-month) elution of the drug, which would allow for the differences in healing and neointimal hyper-plasia observed in diabetic patients. The stent is also designed to exhibit a larger range of motion and increased flexibility due to its use of sinusoidal technology and should therefore be easier to navigate.