The Absorb bioresorbable vascular scaffold (BVS, Abbott Vascular) has been pulled from widespread use in Europe according to an urgent field safety letter issued to cardiologists by Abbott.
Effective May 31, 2017, the stent will only be available for use at select sites participating in a clinical registry that will play a key role in monitoring the technology, the company said.
News of the letter, issued to cardiologists in Europe last week, broke on Twitter yesterday in the US when a copy was posted online.
The move to restrict use of the device comes after concerns were raised that treatment with the stent was associated with a twofold increased risk of target-vessel MI as well as an increased risk of late scaffold thrombosis, compared with the metallic everolimus-eluting stent (Xience, Abbott Vascular) following recent safety data released from the 3-year ABSORB II study.
Abbott has said it is working with European regulatory agencies and the medical expert community to collect more real world evidence to confirm whether improved implantation techniques will mitigate the higher event rates. The registry will also set out to address other concerns around stent thrombosis and duration of dual antiplatelet therapy (DAPT) after implantation.
The company has withdrawn use of the device in hospitals until 2018, when it will review the situation, it said.
It’s more bad news for the device, which has been plagued by controversy in recent years. Just last month findings from the 2-year ABSORB III study presented in a late breaking session at the American College of Cardiology Scientific Sessions revealed that 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 XIENCE.
More evidence against the device emerged just last week as fresh safety concerns were raised after an early analysis of the 2-year results from the Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial (AIDA) revealed that use of BVS was associated with a significantly increased risk of scaffold thrombosis, and of target-vessel MI, compared with patients who received Xience.
On March 27 the TGA issued a safety alert to cardiologists warning them of the increased risk of major adverse cardiac events with Absorb advising them to use caution when selecting the device and follow instructions for patient and target vessel selection, included in the BVS physician labelling.
A spokeswoman for the TGA told the limbic the regulatory body is in discussions with Abbott Vascular to ensure the most up to date worldwide clinical evidence has been presented for the Absorb “to inform any actions to be taken in the Australian context.”