n = 9961% (5020 continued thienopyridine, 4941 received placebo)
Baseline characteristics of groups were similar
Efficacy end-points – 30 months DAPT associated with:
Lower incidence of:
In-stent thrombosis (0.4% vs. 1.4%, HR 0.29, p
Myocardial infarction (2.1% vs. 4.1%, HR 0.47, p
Major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%, HR 0.71, p
Similar incidence of:
Death from cardiac causes (0.9% and 1.0% respectively; P=0.98)
Death from vascular causes (0.1% in each group, P = 0.98)
Stroke (0.8% and 0.9% respectively; P = 0.32)
Higher incidence of:
Death from any cause (2.0% vs. 1.5%, HR 1.36, p=0.05)^
Cancer-related deaths (31 vs. 14, P=0.02) (see discussion)
Safety end-points – 30 months DAPT associated with:
Higher incidence of:
Moderate or severe bleeding (2.5% vs. 1.6%, HR 1.61, p=0.001)
% 25682 started study (DES + BMS), 22866 (DES), 9961 for randomisation (process described above).
Note that myocardial infarction that was not related to stent thrombosis (1.8% vs. 2.9%; hazard ratio, 0.59; P
^ During the secondary-analysis period (month 12 to month 33), all-cause mortality was 2.3% versus 1.8% (HR 1.36; P = 0.04), with the rate of death from noncardiovascular causes (1.1% vs. 0.6%; hazard ratio, 1.80; P=0.01) accounting for the difference in rates between the two analysis periods.