Sirolimus-eluting Orsiro stent non-inferior to zotarolimus-eluting device in BIOFLOW-DAPT trial

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One-year-data from the BIOFLOW-DAPT trial demonstrated non-inferiority and a good safety profile for the Orsiro Mission drug-eluting stent (DES) compared to Resolute Onyx DES (Medtronic) in patients at high risk of bleeding receiving short dual antiplatelet therapy (DAPT).

Marco Valgimigli (Cardiocentro Ticino Foundation, Lugano, Switzerland) presented the data in a late-breaking trial session at the European Society of Cardiology (ESC) congress (25–28 August, Amsterdam, The Netherlands), and the results were published simultaneously in Circulation.

BIOFLOW-DAPT is a prospective, multicentre, international, two-arm randomised controlled clinical study to assess the safety of one-month DAPT in subjects with high bleeding risk. The trial randomised 1,948 patients 1:1 to percutaneous coronary intervention (PCI) with either Orsiro Mission or Resolute Onyx DES.

Patients were treated with DAPT (aspirin and a P2Y12 inhibitor) for one month, followed by single antiplatelet therapy. Clinical follow-up visits were scheduled at one-, six- and 12-month post-procedure.

The primary endpoint was a composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis evaluated at 12 months. It was observed in 3.6% of the Orsiro Mission group and in 3.4% of the Resolute Onyx group (risk difference, 0.2 percentage points; upper boundary of the one-sided 95% confidence interval (CI), 1.8%; non-inferiority margin, 4.1%; p<0.0001 for non-inferiority).

“Until recently the data on the performance of Orsiro stent in patients at high bleeding risk undergoing one-month DAPT was limited to observational studies,” stated Valgimigli. “The results show us that a PCI-strategy with biodegradable-polymer sirolimus-eluting stents like Orsiro Mission followed by 30 days of DAPT is non-inferior to durable-polymer zotarolimus-eluting stents in these patients.”

Prolonged DAPT treatment increases the risk of bleeding after PCI. A reduction of bleeding after PCI is of major interest to patients as has a strong relationship with subsequent all-cause mortality and major adverse cardiovascular events.

“Not only do the results add to the growing body of evidence within our extensive Orsiro DES family clinical programme,” said Georg Nollert, vice president medical affairs, vascular intervention at Biotronik. “They also suggest that one-month DAPT following PCI with Orsiro Mission DES can be considered a safe approach to reduce bleeding risks in these high-bleeding risk patients.”


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