Biotronik’s Orsiro Mission DES With Short DAPT Studied in BIOFLOW-DAPT

August 30, 2023—Biotronik announced that 1-year data from the BIOFLOW-DAPT study demonstrated noninferiority and a good safety profile for the company’s Orsiro Mission drug-eluting stent (DES) compared with the Resolute Onyx DES (Medtronic) in patients at high risk of bleeding receiving short dual antiplatelet therapy (DAPT) percutaneous coronary intervention (PCI).

According to the company, BIOFLOW-DAPT is a prospective, multicenter, international, two-arm, randomized controlled clinical study to assess the safety of 1-month DAPT in patients with high bleeding risk. Investigators enrolled 1,948 patients who were randomized 1:1 to PCI with either Orsiro Mission or Resolute Onyx DES. Patients were treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by single antiplatelet therapy. Clinical follow-up visits were scheduled at 1-, 6- and 12-months postprocedure.

Professor Marco Valgimigli, MD, presented the data in a late-breaking trial session at the European Society of Cardiology’s ESC Congress 2023 held August 25-28 in Amsterdam, the Netherlands. The results were published simultaneously by Prof. Valgimigli, et al in Circulation.

As summarized in Biotronik’s press release, the BIOFLOW-DAPT study’s primary endpoint was a composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis evaluated at 12 months.

The primary endpoint 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% CI, 1.8%; noninferiority margin, 4.1%; P < .0001 for noninferiority).

“Until recently, the data on the performance of Orsiro stent in patients at high bleeding risk undergoing 1-month DAPT was limited to observational studies,” commented Prof. Valgimigli in Biotronik’s press release. “The results show us that a PCI-strategy with biodegradable-polymer sirolimus-eluting stents like Orsiro Mission followed by 30 days of DAPT is noninferior to durable-polymer zotarolimus-eluting stents in these patients.” Prof. Valgimigli is Deputy Chief of Interventional Cardiology at the Instituto Cardiocentro Ticino in Lugano, Switzerland.

Biotronik advised that Orsiro Mission DES is not indicated for 1-month DAPT in high bleeding risk patients. Health care providers are advised to refer to the product’s indications for use and postprocedure antiplatelet therapy recommendations.

In September 2021, Biotronik announced FDA approval of the Orsiro Mission bioabsorbable polymer coronary DES. European CE Mark approval for the Orsiro Mission was announced in February 2020.