TICO Randomized Controlled Trial Establishes Safety and Efficacy of Ticagrelor Monotherapy Alone in ACS Patients Treated with Ultrathin Drug-Eluting Stent Orsiro

According to recently presented TICO trial data, patients with acute coronary syndrome (ACS) treated with BIOTRONIK’s Orsiro^® drug eluting stent (DES) benefit from stopping aspirin three months after stenting and continuing only with ticagrelor monotherapy. Dr. Yang Soo Jang presented the results in a virtual late-breaking clinical trial session at the ACC Congress.¹

The TICO trial is the first randomized, controlled trial (RCT) to demonstrate the safety and efficacy of a shortened dual antiplatelet therapy (DAPT) regimen of three months followed by ticagrelor monotherapy in patients with acute coronary symptom treated with Orsiro. 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=0.01) in patients discontinuing aspirin three months after percutaneous coronary intervention (PCI) and continuing with ticagrelor only, compared to 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. 3.0%, p= 0.02) 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=0.09). The primary endpoint landmark analysis confirmed that divergence arose after three months post-index procedure when aspirin was stopped in the ticagrelor monotherapy group (1.4% vs. 3.5%, p=0.001) compared to the 12-month conventional DAPT group.

“Our findings are consistent with the TWILIGHT trial, which showed the benefit of an aspirin-free strategy in complex and high bleeding risk patients,” explained Dr. Yang Soo Jang, Yonsei University College of Medicine, Seoul, South Korea. “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.”

BIOFLOW-DAPT Trial Enrolls First Patient in One-Month Evaluation of DAPT in High Bleeding Risk Group Treated with Orsiro Mission

Another essential trial on DAPT regimen in a complex subgroup recently started with its first patient enrollment. The BIOFLOW-DAPT randomized controlled trial aims to assess the safety and efficacy of Orsiro^® Mission DES in patients with high risk of bleeding in combination with one month DAPT. Dr. Henning Kelbæk, Sjaellaands University Hospital, Roskilde, Denmark, successfully performed the first implantation.

“The use of DAPT therapy following stent implantation is critical for the prevention of coronary stent thrombosis and other major adverse events,” explained Prof. Valgimigli, Head of Clinical Research, Department of Cardiology, Inselspital, Bern and principal investigator on the study. “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.”

BIOFLOW-DAPT is a prospective, multi-center RCT with a planned enrollment of up to 1,948 patients at more than 80 study sites. Eligible patients with high risk of bleeding 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 TICO study not only provides valuable insights into the treatment of ACS patients, but further underscores Orsiro's clinical performance with low stent thrombosis and target vessel revascularization rates in both arms," noted Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. "We look forward to demonstrating Orsiro Mission’s performance in challenging, high bleeding risk patients in the recently initiated BIOFLOW-DAPT study."

References:

^{1 Randomized Evaluation Of Ticagrelor Monotherapy After 3-month Dual-antiplatelet Therapy In Acute Coronary Syndrome The TICO trial. Presented at: ACC20/WCC Virtual. March 30, 2020.}

^{* Net adverse clinical events were defined as a combined occurrence of TIMI major bleeding and all-cause death, myocardial infarction, stent thrombosis, stroke or target vessel revascularization.}

^{** Major averse cardiac and cerebrovascular events were defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke or target vessel revascularization.}

^{Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.}

^{Orsiro is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm*) in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.}

^{Physicians should use the information from the current sirolimus eluting stent literature and national and international guidelines on PCI concerning the selection, dosage, duration and combination of different antithrombotic drugs. Orsiro is not indicated for ACS patients.}