The TGA is warning cardiologists that treating patients with the Absorb Bioresorbable Vascular Scaffold (BVS, Abbott Vascular) may increase the risk of major adverse cardiac events.
In a safety alert issued late Monday the regulator said the stent was associated with greater rates of cardiac death, heart attack, and the need for an additional procedure to re-open the treated heart vessel compared to a conventional metallic drug eluting stent.
The warning is a direct response to the publication of two-year data from the ABSORB III trial that compared BVS with the metallic XIENCE drug-eluting stent manufactured by Abbott Vascular.
According to the warning the events were most likely to occur when the device was placed in small coronary vessels.
The drug authority advised physicians to “use caution when selecting this device, in particular follow instructions for patient and target vessel selection, included in the BVS physician labelling.”
It has also asked doctors to advise patients to follow the recommendations for DAPT prescribed by their health care providers and to seek clinical care if they experience any new cardiac symptoms.
The warning follows a similar alert issued to physicians by the FDA last week on the morning the safety data from ABSORB III were presented at the American College of Cardiology Scientific Sessions.
In the late breaking session investigators said at two years, the results for Xience DES were statistically superior compared with BVS, including a lower risk of TV-MI.
The investigators said the Absorb BVS might perform Xience beyond three years once the scaffold has completely gone. Longer-term data are awaited to see if that theoretical advantage plays out.
In the meantime, both the TGA and FDA say they continuing to analyse these outcomes and to monitor the performance of the BVS in ongoing clinical studies and adverse event reporting.