The TAXUS® stent, manufactured by Boston Scientific Inc, is a small, flexible sleeve of stainless steel mesh, used to improve blood flow in coronary arteries for people whose arteries have been narrowed by coronary artery disease.
Inserted into a coronary artery, the expandable stent helps keep the artery open, allowing a better blood supply to the heart.
The TAXUS® stent is a drug eluting stent, (DES), in which the mesh of the TAXUS® stent is coated with Paclitaxel, a medication intended to prevent restenosis, the reblocking of the artery.
The FDA approved the TAXUS® stent in 2004, and since then more than 3 million TAXUS® stents have been implanted in patients in the US and around the world for treatment of coronary artery disease.
At the time of the original approval, the FDA required Boston Scientific to follow the patients involved in the original clinicaltrials for 5 years after implantation of the TAXUS® stent and also to follow new patients who had the TAXUS® stent implanted.
As Boston Scientific conducted the follow-up studies mandated by the FDA, many cases of thrombosis at the site of the TAXUS® stent were reported.
Thrombosis is the formation of a blood clot.
Blood clots are extremely dangerous, because they can block the artery, causing heart attacks, even death.
In the period 18 to 36 months after implantation, patients with the TAXUS® drug-coated stent experienced higher rates of clotting and death than patients who had bare-metal stents.
Patients who have not developed clots may still need to take expensive antiplatelet medication indefinitely in order to prevent thrombosis.
Some TAXUS® stent recipients have suffered side effects from Paclitaxel, the drug coating.
These include
It is very important to continue any anticlotting medications that have been prescribed.
Inserted into a coronary artery, the expandable stent helps keep the artery open, allowing a better blood supply to the heart.
The TAXUS® stent is a drug eluting stent, (DES), in which the mesh of the TAXUS® stent is coated with Paclitaxel, a medication intended to prevent restenosis, the reblocking of the artery.
The FDA approved the TAXUS® stent in 2004, and since then more than 3 million TAXUS® stents have been implanted in patients in the US and around the world for treatment of coronary artery disease.
At the time of the original approval, the FDA required Boston Scientific to follow the patients involved in the original clinicaltrials for 5 years after implantation of the TAXUS® stent and also to follow new patients who had the TAXUS® stent implanted.
As Boston Scientific conducted the follow-up studies mandated by the FDA, many cases of thrombosis at the site of the TAXUS® stent were reported.
Thrombosis is the formation of a blood clot.
Blood clots are extremely dangerous, because they can block the artery, causing heart attacks, even death.
In the period 18 to 36 months after implantation, patients with the TAXUS® drug-coated stent experienced higher rates of clotting and death than patients who had bare-metal stents.
Patients who have not developed clots may still need to take expensive antiplatelet medication indefinitely in order to prevent thrombosis.
Some TAXUS® stent recipients have suffered side effects from Paclitaxel, the drug coating.
These include
- inflammation of the arterial wall
- allergic response
- anemia
- muscle and joint pain and muscle weakness
- abnormal liver values
- gastrointestinal disturbances
- hair loss
It is very important to continue any anticlotting medications that have been prescribed.
Source...