Medtronic plc 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.
Per a report by ResearchAndMarkets, the global peripheral vascular devices market is expected to reach $14,395 million by 2024 from an estimated $10,338.6 million in 2019, witnessing a CAGR of 6.8%. The key factors driving the market include sustained growth in the elderly population and the associated increase in the prevalence of peripheral vascular diseases as well as approval of new and advanced products.
Medtronic has seen quite a few developments in terms of regulatory go-ahead in recent times.
Resolute Onyx DES obtained the CE Mark in September 2014 and FDA approval in April 2017.
Medtronic announced receiving the FDA approval in September 2019 to begin an early feasibility study (“EFS”) for its Intrepid transcatheter mitral valve replacement (“TMVR”) system, using a minimally-invasive transfemoral access approach.
The company received another FDA approval in the same month, with respect to the Evolut PRO+ TAVR System.
In August, it received the FDA nod for the Evolut Transcatheter Aortic Valve Replacement (“TAVR”) system for patients with symptomatic severe native aortic stenosis, who are at low risk of surgical mortality.
Comparison With Peers
In heart valves devices space, Medtronic’s major peer Boston Scientific BSX recently announced the primary endpoint results from the EVOLVE Short DAPT study.
Abbott Laboratories ABT started the clinical trial of assessing short-term use of common blood-thinning medicines (DAPT) after it received the XIENCE everolimus-eluting coronary stent in July 2017. The company received CE Mark for XIENCE Sierra, the latest offering of XIENCE everolimus-eluting coronary stent system in October 2017.
Edwards Lifesciences EW received the FDA nod in August 2019 for the expansion of Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems for the treatment of severe, symptomatic aortic stenosis (“AS”) patients, who are at low risk of open-heart surgery.
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