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.