Contribution To Literature:
The TICO trial showed that ticagrelor monotherapy after 3 months of DAPT was superior at preventing ischemia and bleeding after PCI for ACS.
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Description:
The goal of the trial was to evaluate ticagrelor monotherapy after 3 months of dual antiplatelet therapy (DAPT) compared with 12 months of DAPT after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).
Study Design
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- Randomized
- Parallel
- Stratification
- Open-label
Patients undergoing PCI for ACS were randomized to ticagrelor monotherapy after 3 months of DAPT (n = 1,527) versus standard therapy (n = 1,529).
- Total number of enrollees: 3,056
- Duration of follow-up: 12 months
- Mean patient age: 61 years
- Percentage female: 21%
- Percentage with diabetes: 27%
Inclusion criteria:
- ACS treated with the ultrathin bioresorbable polymer sirolimus-eluting stent (Orsiro)
- ≥19 years of age
Exclusion criteria:
- >80 years of age
- Increased risk of bleeding
- Need for oral anticoagulation therapy
- Current or potential pregnancy
- Hepatic dysfunction
- Bradycardia
Other salient features/characteristics:
- Clinical presentation: unstable angina 29%, non–ST-segment elevation myocardial infarction (NSTEMI) 35%, STEMI 36%
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Principal Findings:
The primary outcome, net adverse clinical events (death, MI, stent thrombosis, stroke, target vessel revascularization, or Thrombolysis in Myocardial Infarction [TIMI] major bleeding) at 12 months, occurred in 3.9% of the ticagrelor monotherapy after 3 months of DAPT group compared with 5.9% of the standard therapy group (p = 0.01). Association of ticagrelor monotherapy after 3 months of DAPT vs. standard therapy on the primary outcome: overall hazard ratio (HR) = 0.66, no multivessel disease HR = 0.41, multivessel disease HR = 0.86 (p for interaction = 0.04). Landmark analysis at 3 months for ticagrelor monotherapy vs. standard therapy for the primary outcome: (HR 0.41, p = 0.001).
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Secondary outcomes:
- Major bleeding at 12 months: 1.7% of the ticagrelor monotherapy after 3 months group compared with 3.0% of the standard therapy group (p = 0.02)
- Stent thrombosis at 12 months: 0.4% of the ticagrelor monotherapy after 3 months group compared with 0.3% of the standard therapy group (p = 0.53)
- TICO-STEMI subgroup analysis: Major adverse cardiac and cerebrovascular events at 12 months: 2.7% of the ticagrelor monotherapy after 3 months group compared with 2.5% of the standard therapy group (p = 0.81)
Interpretation:
Among ACS patients who underwent PCI with an ultrathin biodegradable-polymer sirolimus-eluting stent, ticagrelor monotherapy after 3 months of DAPT was superior to standard therapy of DAPT for 12 months. Ticagrelor monotherapy was effective at preventing net composite ischemic and bleeding events. Bleeding events were defined by the TIMI criteria, which by way of reminder includes fatal bleeding, overt bleeding with drop in hemoglobin ≥5 g/dl or a 15% drop in hematocrit, and any intracranial hemorrhage.
This trial is like the similarly designed but placebo-controlled TWILIGHT trial. Neither of these trials addressed if aspirin monotherapy, instead of ticagrelor monotherapy in the 3- to 12-month period, would be equally effective. Ticagrelor monotherapy appears to be an emerging strategy, especially for patients with increased bleeding risk, after a short duration of DAPT.
References:
Presented by Dr. Byeong-Keuk Kim at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 14, 2020.
Presented by Dr. Byeong-Keuk Kim at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 30, 2020.
Clinical Topics:Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention, Anticoagulation Management and ACS, Interventions and ACS
Keywords:acc20, ACC Annual Scientific Session, Acute Coronary Syndrome, Angina, Unstable, Anticoagulants, Aspirin, Drug-Eluting Stents, Hematocrit, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, TCT20, Thrombosis, Transcatheter Cardiovascular Therapeutics
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