Primary efficacy outcome
The occurrence of primary efficacy outcome was similar in both groups.
It was reached 9.5% (21/220) in DAPT group and 6.3% (19/304) in ACT
group [hazard ratio (HR), 1.58; 95% confidence interval (CI),
0.84-2.97; P=0.14]. None of the components of the primary efficacy
outcome was significantly different between the two groups.
Thromboembolic events occurred in 3.2% (7/220) in DAPT and 3.6%
(11/304) in ACT groups (HR, 0.94; 95%CI, 0.37-2.41; P=0.90). In the
DAPT group, seven patients experienced thromboembolic events (five ISs
and two TIAs, incidence of 3.2%), including one non-disabling ischemic
stroke and one TIA documented during the first 3 months post LAAC, and
one TIA, three disabling, and one non-disabling ischemic strokes that
occurred under single aspirin therapy during follow-up. In the ACT
group, 11 patients experienced thromboembolic events (eight ISs and
three TIAs, incidence of 3.6%). Among them, one non-disabling ischemic
stroke occurred in the third month after the procedure, when the patient
was on DAPT treatment. Three patients suffered from TIA and three
patients from non-disabling and four disabling strokes under single
aspirin therapy. The all-cause mortality was higher (P=0.02) in the DAPT
group. A non-significant trend for a higher rate of cardiovascular and
unexplained deaths (P=0.05) was observed in the DAPT group. See details
in Table 3.