Boston Scientific has hit back at claims that the company’s Taxus paclitaxel-eluting stent may be associated with an increased risk of death and cardiac events compared with bare metal stents.
Speaking at the World Congress of Cardiology (WCC) in Barcelona, Spain, Donald Baim, executive vice president, chief medical and scientific officer at Boston Scientific, told PharmaTimes that much larger analyses performed by the company had refuted any increased risk of death or myocardial infarction.
“This story is very detrimental from a public health perspective because it has scared patients and some doctors away from using drug eluting stents and deriving the benefits of these stents - including a dramatic reduction in repeat interventions,” he said.
Analyses performed by Boston on data from 3,445 patients followed for up to three years in the TAXUS II, IV, V and VI studies show a low rate of late stent thrombosis of about 0.2% per year. “Over a three year period, we had 8 late thromboses out of 1718 Taxus patients – a rate of 0.46% over three years.” He added that the equivalent rate for the Cypher stent was 0.57% over three years.
“The take home message is that there is a small incidence of late stent thrombosis beyond six months for drug eluting stents, but the magnitude is small at about 0.2% per year, and this appears to be a class effect.”
However unlike the BASKET-LATE and Camezind data presented at the ESC, there was no difference in all cause mortality, cardiac death, or rate of myocardial infarction for Taxus versus bare metal stents.
“Our data in ten times the number of patients says that with the Taxus stent, we do not see an increase in death and MI.”
He said he could not comment on the finding of a 38% increase in the rate of death and Q-wave MI observed for the sirolimus-eluting Cypher stent manufactured by rival Cordis.
“Our data shows that there is no death or MI penalty for Taxus, versus bare metal stents. Taxus has shown a sustained target lesion revascularization benefit with a greater than fifty per cent reduction out to three years. From the patient perspective, there is a very good chance that they will never need another procedure to refix that segment of vessel. This is the driving benefit [for using a drug eluting stent]”
Dr Baim was recruited to Boston in July 2006 to help sort out the intellectual property that came with the company’s acquisition of Guidant. He was formerly a Professor of Medicine at Harvard Medical School and Senior Physician at the Brigham and Women’s Hospital.
“I have been working in device development for a long time. I think that the move to Boston will enable me to have a much greater impact on the future of interventional cardiology,” he said.
