Boston Scientific has announced positive data from the EVOLVE Short DAPT clinical trial of its Synergy Bioabsorbable Polymer (BP) Stent in patients at high bleeding risk after percutaneous coronary intervention.
The trial aimed to determine the safety of a shortened dual antiplatelet therapy (DAPT) duration following treatment with the Synergy stent. Results showed that a three-month DAPT regimen is non-inferior to a 12-month or longer regimen.
EVOLVE Short DAPT trial involved a total of 2,009 subjects, including 1,487 patients eligible to stop DAPT at three months. Participants received an implant of at least one Synergy stent.
The co-primary endpoints of the trial were the rate of death or myocardial infarction (MI) and the rate of stent thrombosis between three and 15 months. The company noted that both endpoints were met.
According to findings, the rate of death or MI between three and 15 months was non-inferior in patients who received the three-month DAPT versus those on 12-month DAPT.
The rate of stent thrombosis between three and 15 months was 0.3% in the three-month DAPT group, which is said to be considerably lower compared to the endpoint performance goal of 1%.
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Boston Scientific executive vice-president and global chief medical officer Ian Meredith said: “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.
“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.”
Earlier this month, the Synergy Megatron BP Stent received the European CE-Mark.