The findings of a new study suggest that prescribing Plavix following transcatheter aortic-valve implantation (TAVI) provides few benefits, while increasing the risk of serious bleeding events.
Dutch researchers found a 64% increased risk of bleeding when patients undergoing TAVI were given an oral anticoagulant plus Plavix (clopidogrel), as opposed to when given an oral angicoagulant alone.
The study was published on March 29 in the New England Journal of Medicine, outlining the results of a randomized trial involving 313 patients who underwent transcatheter aortic-valve replacement while also receiving oral anticoagulants. Half the patients were given just the oral anticoagulants while the other half were also given Plavix along with an oral blood thinner. Researchers looked for all bleeding and non-procedure-related bleeding events over the course of a year.
According to the findings, bleeding events occurred in 34 of the 157 patients given just an oral anticoagulant, representing just under 22%. However, among the group of patients also given Plavix, 54 of the 156, or 34.6%, experienced bleeding events, indicating a 64% increased risk.
The researchers indicated that most of the bleeding events were at the TAVI access site, occurred in the first month, and were minor.
“In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel,” the researchers concluded.
Plavix Health Risks
Plavix (clopidrogrel) is a blockbuster medication that has been used by millions of people in the United States and is commonly prescribed to prevent blood platelets from sticking together and forming clots. There are between 2.5 million and 3 million Plavix prescriptions handed out each month in the U.S.
In November 2014, the FDA issued a Plavix safety warning after researchers found that Plavix use after the placement of a stent could increase the risk of death.
In recent years, additional concerns have emerged about the potential side effects of Plavix and whether many of these prescriptions may have been unnecessary due to genetic resistance to the medication.
Unnecessary use of Plavix may expose individuals to an increased risk of gastrointestinal bleeding, severe ulcers, a rare blood disorder known as thrombotic thrombocytopenic pupura (TTP) and other injuries.
TAVR is a heart procedure which allows a surgeon to replace a damaged heart valve by threading it through the femoral artery in the leg instead of via open heart surgery. It places the valve over the damaged aortic valve in a less invasive procedure.
TAVR was first approved for high risk patients who could not undergo open heart surgery because of the risks; typically older patients. However, in recent years some have raised questions about the valves’ durability in younger patients.
In addition, rates of surgical bailout, requiring the surgeon to convert from the TAVR procedure to open heart surgery mid-procedure, still remain high and are linked to increased risk of death. Overall, complication rates have decreased over time, but there are still many risks involved with TAVR, as well as open heart surgery.
Patients considering either surgery who are a candidate for both, should discuss the benefits and risks of both procedures before proceeding, considering the new results indicate one procedure does not have improved outcomes over another, health experts say. Both surgeries carry significant risk.