Study establishes safety and efficacy of ticagrelor monotherapy in acute coronary syndrome patients treated with Orsiro

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Orsiro

According to recently presented TICO trial data, a press release reports, patients with acute coronary syndrome treated with the Orsiro drug-eluting stent (Biotronik) benefit from stopping aspirin three months after stenting and continuing only with ticagrelor monotherapy. Yang Soo Jang (Yonsei University College of Medicine, Seoul, South Korea) presented the results in a virtual late-breaking clinical trial session at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual).

The TICO trial is the first randomised, controlled trial 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 acute coronary syndrome 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) favouring 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.

Jang comments: “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 acute coronary syndrome patients treated with the Orsiro stent and providing further clinical evidence for the safety of a shortened DAPT treatment beyond the current guidelines.”


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