The TGA has moved to restrict use of a controversial cardiac stent in Australia amid growing fears worldwide that the device is linked to elevated rates of heart attack and thrombosis.
Issuing a safety alert yesterday, the drug and medical devices watchdog said its decision to remove the Absorb BVS System (Abbott Vascular) from the ARTG was based on recent data that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with another stent.
The Absorb BVS System will now be only be available in Australia through clinical trials and the unapproved product pathways schemes, the regulator said.
The Australian recall comes just weeks after an urgent field safety notice issued to cardiologists in Europe and detailing the company’s concerns about the device was leaked on twitter.
The letter, written by Abbott, said it was withdrawing the stent from widespread use in Europe effective May 31, 2017 restricting its availability to select sites participating in a clinical registry. It also said no further BVS stents will be provided to non-registry sites after March 31, 2017.
“These sites are instructed to cease implants and existing inventory will be removed,” the letter stated.
In that letter the pharmaceutical company said it was awaiting further data to answer questions about optimal DAPT duration after implantation and to confirm whether improved implantation techniques would mitigate the higher event rates.
It’s been a bad year for the contentious stent as a flood of concerns about safety began to pour in from around the world.
In March the FDA announced that it was launching an investigation into the increased rate of major adverse cardiac events with Absorb BVS after two-year data from the ABSORB III trial revealed the device was associated with greater rates of cardiac death, heart attack, and the need for an additional procedure to re-open the treated heart vessel, when compared to patients treated with the XIENCE stent also manufactured by Abbott.
The US investigation prompted the TGA to issue its own safety alert that same month warning cardiologists to use caution when selecting the device and to follow instructions for patient and target vessel selection included in the BVS physician labelling.
And last month, a study in the NEJM added more pressure on Abbott. An early analysis of the 2-year results from the Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial (AIDA) revealed that use of use of BVS was associated with a significantly increased risk of scaffold thrombosis, and of target-vessel MI, compared with patients who received Xience.
“Given the lack of putative benefit in the ABSORB Japan and ABSORB II trials, the advantage of bioresorbable technology over metallic stents remains to be established,” the investigators said.
The TGA says cardiologists should advise patients who have received the implant to be aware of the signs and symptoms of adverse cardiac events.
“Instruct them to seek clinical care if they experience any new symptoms. Additionally, advise them to continue taking DAPT as prescribed,” it said.