In a nutshell
The aim of this study was the compare the safety and effectiveness of the new FIREHAWK stent to the XIENCE stent in the management of coronary artery disease. The study found that the FIREHAWK was not inferior to the XIENCE stent at 12 months.
Some background
Coronary artery disease (CAD) means that the blood vessels to the heart become blocked. Placing stents in the blood vessels of the heart is an important part of the management of CAD. Stents are small tubes that keep the blood vessels open. This allows blood to flow to the heart muscle.
There are many different kinds of stents. A drug-eluting stent (DES) slowly releases a drug over time to prevent the blood vessel from becoming blocked again. XIENCE is a DES that is currently used. However, due to its durability, it has been associated with delayed blood vessel healing and inflammatory reactions.
FIREHAWK is a new DES that has a biodegradable coating. Therefore, it will be fully absorbed over time. It is unknown how FIREHAWK compares to XIENCE in the treatment of CAD.
Methods & findings
This study included 1563 patients who were randomly assigned to either receive the FIREHAWK (823 patients) or XIENCE (830 patients). Patients were followed for 12 months. The effectiveness of the stents was measured by target lesion failure (TLF). This includes death due to heart disease, heart attack due to blockage in the vessel with the stent and the need for another procedure on the stent.
At 12 months, TLF occurred in 6.1% in the FIREHAWK group compared to 5.9% in the XIENCE group. There were no differences in the rate of stent blockages at 12 months. The FIREHAWK had a slightly narrower blood vessel passage compared to the XIENCE.
The bottom line
The authors concluded that the FIREHAWK was not inferior to XIENCE in the treatment of CAD at 12 months.
The fine print
This study was funded by Shanghai MicroPort Medical, the developer of FIREHAWK. This study had a short follow up period. Longer-term studies are needed to evaluate the safety and effectiveness of this stent.
Published By :
Lancet (London, England)
Date :
Sep 03, 2018
