Medtronic, Boston Scientific stand by stents despite critical study - (Star Tribune via NewsPoints Desk)

  • Medtronic and Boston Scientific said they are not backing away from drug-eluting stents and balloons used in blood vessels in the legs, despite an analysis published last month in the Journal of the American Heart Association linking the devices to a significantly increased risk of death, Star Tribune reported.

  • The study looked at trials published since 2011 that included the experiences of 4663 patients implanted with devices made by Medtronic,  Boston Scientific, Cook Medical, CR Bard, Spectranetics, Biotronik, including Medtronic's In.Pact Admiral drug-coated medical balloon and Boston Scientific's Ranger drug-coated balloon.

  • For the 12 trials that had at least two years of data, the meta-analysis found rates of death were the same between device and non-device patients for the first year after implant, but the all-cause death rate was 7.2 percent for the paclitaxel-device group versus 3.8 percent for the control group at two years, and a few studies with five years of data found the same enhanced risk among the paclitaxel-device patients.

  • Medtronic cardiac and vascular group president Mike Coyle said that "we've generated a ton of clinical evidence: 1800 patients, we have data out to five years, randomised controlled study for the US, randomized controlled clinical study for Japan, global registry data. And all of these data have been analysed. We have not seen this safety signal in our data."

  • Meanwhile, Boston Scientific global chief medical officer Ian Meredith said meta-analyses sometimes reach findings that are not borne out in later trials, adding that "there does not seem to be a plausible mechanism to understand how a dose that is imperceptible in plasma or tissue at 30 days could actually really affect mortality two years and beyond."

  • However, lead study author Konstantinos Katsanos noted that "I do understand the skepticism of the industry, but at the end of the day, the statistical signal is too strong to be ignored by reasonable doubt."

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