Medtronic Upbeat On Drug-Eluting Stents In Patients With DAPT

 | Oct 01, 2019 09:23PM ET

Medtronic plc (NYSE:MDT) has announced the release of clinical data from the Onyx ONE Global Study. The company claims this to be the first potential, multi-center, randomized study, assessing clinical results between two drug-eluting stents (“DES”) in approximately 2,000 high-bleeding risk (“HBR”) patients with one month of dual antiplatelet therapy (“DAPT”).

Results of the study were presented at the clinical trial session at the 31st Transcatheter Cardiovascular Therapeutics (TCT) (the annual scientific symposium of the Cardiovascular Research Foundation) in San Francisco.

With the publication of the study, Medtronic aims to fortify its position in the global peripheral vascular devices market.

The Study in Detail

The main objective of the study was to fulfill the primary composite endpoint of proving that it is no way inferior to the comparator stent, BioFreedom DCS, with respect to cardiac death, myocardial infarction (MI) or stent thrombosis (ST) at one-year. Along with this, the study confirmed better performance of Resolute Onyx, with shortened DAPT.

Per Medtronic, BioFreedom DCS is the only DES mentioned by the European Society for Cardiology (ESC) in its guidelines for HBR patients, who may need one-month DAPT.

The results obtained from the study, with respect to target lesion revascularization (“TLR”) and ST, were quite impressive for Resolute Onyx compared with BioFreedom.

Significance of the Study

Per the medical fraternity participating in the study, with the increasing number of patients with HBR, who make up almost 40% of percutaneous coronary intervention (PCI) patients, it was crucial to generate randomized clinical evidence to assess results for these patients. The positive outcome of the study will likely aid physicians to shorten the duration of DAPT, following PCI among HBR patients.

The most important outcome of this study is obtaining low event rates for Resolute Onyx after the discontinuation of DAPT at one month. The composite endpoint (cardiac death, ST, MI) of the study was quite spectacular.

Industry Prospects

Per a report by Zacks Investment Research

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