May 6, 2020
First Patient Enrolled in Biotronik's BIOFLOW-DAPT Trial
May 6, 2020—Biotronik announced the enrollment of the first patient in the BIOFLOW-DAPT trial evaluating a dual-antiplatelet therapy (DAPT) regimen in a complex subgroup of patients undergoing percutaneous coronary intervention (PCI). The randomized controlled trial aims to assess the safety and efficacy of the company's Orsiro Mission drug-eluting stent (DES) in combination with 1-month DAPT in patients with a high risk of bleeding.
The prospective, multicenter trial has a planned enrollment of up to 1,948 patients at > 80 study sites. Eligible high bleeding–risk patients will be randomized 1:1 to receive either the Orsiro Mission DES or the Medtronic Resolute Onyx DES. The trial’s primary endpoint is a composite rate of cardiac death, myocardial infarction, and definite or probable stent thrombosis assessed at 12 months.
The first implantation was successfully performed by Henning Kelbæk, MD, of Sjaellaands University Hospital in Roskilde, Denmark. The BIOFLOW-DAPT trial's principal investigator is Professor Marco Valgimigli, MD, who is Head of Clinical Research, Department of Cardiology at Inselspital in Bern, Switzerland.
“The use of DAPT therapy following stent implantation is critical for the prevention of coronary stent thrombosis and other major adverse events,” stated Prof. Valgimigli in the company's press release. “Until today, clinical results have been controversial in defining the optimal DAPT therapy for an often under-represented patient group that faces an increased risk of cardiovascular events. Our study will help us determine the optimal DAPT duration in this challenging population undergoing PCI with the newly launched Orsiro Mission DES.”
Additionally, Biotronik announced that data from the TICO RCT demonstrated the safety and efficacy of a shortened DAPT regimen of 3 months after stenting followed by ticagrelor monotherapy in patients with acute coronary syndrome (ACS) treated with Orsiro. Yangsoo Jang, MD, presented the results at ACC.20/WCC Virtual, the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology held online March 28–30.
Dr. Jang, who is from Yonsei University College of Medicine in Seoul, South Korea, commented in the company's announcement, “Our findings are consistent with the TWILIGHT trial, which showed the benefit of an aspirin-free strategy in complex and high bleeding–risk patients. Our trial indicates the optimal strategy; balancing both ischemic and bleeding risks in ACS patients treated with the Orsiro stent and providing further clinical evidence for the safety of a shortened DAPT treatment beyond the current guidelines.”
The company reported that TICO's primary endpoint results of the 3,056 ACS patients enrolled showed significantly lower rates of net adverse cardiac events (3.9% vs 5.9%; P = .01) in patients discontinuing aspirin 3 months after PCI and continuing with ticagrelor only, compared with patients following a conventional DAPT therapy for 12 months.
The difference seen in the primary endpoint was mainly driven by significantly lower rates of major bleeding (1.7% vs 3%; P = .02) favoring the ticagrelor monotherapy arm, without significant differences observed between the two groups in regard to major adverse cardiac and cerebrovascular events (2.3% vs 3.4%; P = .09). The primary endpoint landmark analysis confirmed that divergence arose after 3 months postindex procedure when aspirin was stopped in the ticagrelor monotherapy group (1.4% vs 3.5%; P = .001) compared with the 12-month conventional DAPT group, noted Biotronik.