SAN FRANCISCO and MARLBOROUGH, Mass., Sept. 26, 2019 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has announced primary endpoint results from the EVOLVE Short DAPT clinical trial, the first prospective study initiated in the U.S. to examine the safety of a shortened duration of dual antiplatelet therapy (DAPT) in patients at high risk for bleeding. Results were presented during a late-breaking clinical science session at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Francisco, and demonstrated that a three-month regimen of DAPT is non-inferior to a 12-month or longer regimen in patients with an increased risk of bleeding after being treated with the SYNERGY™ Bioabsorbable Polymer (BP) Stent.
Patients within the trial were implanted with at least one SYNERGY BP stent and considered at high risk for bleeding after meeting at least one of the criteria such as: age of 75 or older with the risk of longer term DAPT deemed greater than the benefit, a history of stroke, renal insufficiency or failure, the need for chronic anticoagulation therapy or history of major bleeding in the prior 12 months. The co-primary endpoints of the study assessed the rate of death or myocardial infarction (MI) and the rate of stent thrombosis between three and 15 months. Both primary endpoints were successfully met.
"These data prospectively demonstrate a low rate of adverse events for patients who are at high risk for bleeding and who then stop DAPT at three months," said Ajay Kirtane, M.D., director of Cardiac Catheterization Laboratories at Columbia University Irving Medical Center/New York-Presbyterian Hospital and principal investigator of the EVOLVE Short DAPT trial. "This is critically important information because previously, the required duration of DAPT following implantation of current generation drug-eluting stent platforms was unknown. These data better inform physicians as to how best to tailor the recommended duration of DAPT to the bleeding risk of the patients they treat."
The global EVOLVE Short DAPT trial enrolled 2,009 patients and of those, 1,487 patients were eligible to discontinue dual-antiplatelet therapy at three months. In patients treated with a short DAPT regimen, investigators found that the rate of death or MI between three and 15 months was non-inferior in the three-month DAPT group compared to a historical control group of patients treated with 12-month DAPT (5.6% vs. 5.7%, p-value for non-inferiority was 0.002). Additionally, the rate of stent thrombosis between three and 15 months in the patients treated with three-month DAPT was 0.3%, significantly lower than the endpoint performance goal of 1.0%.
"We are pleased the study presented today provided robust safety data on shortened DAPT following implantation of the SYNERGY BP Stent for this patient population, as the reduced length of therapy can be a clinically significant differentiator," said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific. "We continue to build upon the body of evidence supporting the excellent clinical outcomes of the SYNERGY BP Stent and look forward to submitting these data to regulatory authorities to support an indication for use of this stent in patients at high risk of experiencing a bleeding event."
This month, the company received CE Mark for the SYNERGY MEGATRON™ Bioabsorbable Polymer (BP) Stent, the newest stent within the SYNERGY family of products. The SYNERGY MEGATRON BP stent is designed for use in large proximal vessels and features architecture with increased strength as well as the ability to expand to 6.0mm in diameter and accommodate tapered vessels.
Please see the SYNERGY BP Stent Directions for Use for full antiplatelet prescribing information.
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