Boston Scientific (BSX) Upbeat On Results Of EVOLVE Study
Zacks Investment Research | Sep 30, 2019 08:59AM ET
Boston Scientific Corporation (NYSE:BSX) recently announced the primary endpoint results from the EVOLVE Short dual antiplatelet therapy (“DAPT”) clinical trial. The company claims it to be the first DAPT study in patients at high risk for bleeding. The study was conducted to observe the safety of a shortened duration of DAPT in such patients.
The results of the study, presented at the clinical science session at the 31st Transcatheter Cardiovascular Therapeutics (“TCT”) (the annual scientific symposium of the Cardiovascular Research Foundation) in San Francisco, confirmed that a three-month regimen of DAPT yields similar results to a 12-month or longer treatment in patients with an increased risk of bleeding after being treated with the SYNERGY Bioabsorbable Polymer (“BP (LON:BP)”) Stent.
With the publication of the positive outcome of this study, the company aims to fortify its presence in the global percutaneous coronary intervention market.
The Study in Detail
Patients selected for this study were initially implanted with at least one SYNERGY BP stent and considered at high risk for bleeding after fulfilling at least one of the criteria such as the age of 75 or older, with potential risk of long-term DAPT. Objectives of the study were to assess the death rate or myocardial infarction (MI), and the rate of stent thrombosis between three and 15 months, which were successful.
Out of 2009 patients enrolled for the study, 1487 were eligible to discontinue the dual-antiplatelet therapy after three months. Patients treated with a short DAPT regimen were seen to exhibit similar results as patients treated with 12-month DAPT. Also, the rate of stent thrombosis between three and 15 months in the patients treated with three-month DAPT was much lower than the expectations of the study.
Significance of the Study
Per the medical fraternity participating in the study, the positive outcome of the study will likely inform physicians how to shorten the duration of DAPT to the bleeding risk of patients. Earlier, the mandatory period of DAPT, following implantation of current-generation drug-eluting stent platforms, was unknown.
Based on the positive outcomes, the company is looking forward to submitting these data to supervisory authorities to get approvals for the use of stent in patients at high risk of bleeding.
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