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Thursday, September 26, 2019

Medtronic DES stent successful in large-scale study in high-bleeding risk patients

Results from a 2000-subject study, Onyx ONE, comparing Medtronic’s (MDT +0.5%) Resolute Onyx drug-eluting stent (DES) to Biosensor International’s BioFreedom drug-coated stent (DCS) in high-bleeding risk (HBR) patients with one month of dual antiplatelet therapy (DAPT) showed the non-inferiority (no worse than) of the Medtronic device as measured by a composite of cardiac death, myocardial infarction or stent thrombosis at year one. The data were presented at Transcatheter Cardiovascular Therapeutics Conference in San Francisco.
The rate of the composite adverse event endpoint at year one was 7.5% for Resolute Onyx versus 8.8% for BioFreedom, including a significantly lower rate of heart attacks (-4.3% vs. 6.8%, p<0.01) one month after the discontinuation of DAPT.
Resolute Onyx also demonstrated better acute performance with a success rate of 92.8% versus 89.7% for BioFreedom (p=0.007).

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