4. Trial design: Randomized, Parallel, Stratification, Open-label
assessment.
Sample size: 3,056 individuals
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
TICO
5. Methodology:
Patients undergoing PCI for ACS were randomized to ticagrelor
monotherapy after 3 months of DAPT (n = 1,527) versus standard
therapy (n = 1,529).
Individuals are followed up after 12 months
Mean patient age is 61 years
Percentage female is 21%
27% percentage of individuals are with diabetes
TICO
6. Results:
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:
o Overall hazard ratio (HR) = 0.66,
o No multivessel disease HR = 0.41,
o 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).
Continued….
TICO
7. Secondary Outcome:
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)
TICO
8. Conclusion:
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.
Ticagrelor monotherapy appears to be an emerging strategy,
especially for patients with increased bleeding risk, after a short
duration of DAPT.
TICO