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. 2018 Oct 2;363:k3793. doi: 10.1136/bmj.k3793

Table 2.

Clinical outcomes at 18 months after randomisation. Values are numbers (percentages) unless stated otherwise

Outcome SAPT (n=433) DAPT (n=437) Hazard ratio SAPT v DAPT (95% CI) P value
Primary endpoint
Composite* 21 (4.8%) 29 (6.6%) 0.73 (0.41 to 1.27) 0.26
0.004 for non-inferiority
Secondary endpoints
Composite 14 (3.2%) 19 (4.3%) 0.75 (0.37 to 1.49) 0.40
Death: 3 (0.7%) 6 (1.4%) 0.51 (0.13 to 2.02) 0.33
  Cardiac 2 (0.5%) 4 (0.9%) 0.51 (0.09 to 2.76) 0.43
Myocardial infarction 8 (1.8%) 8 (1.8%) 1.02 (0.38 to 2.71) 0.97
Revascularisation: 13 (3.0%) 17 (3.9%) 0.87 (0.42 to 1.83) 0.72
  Urgent 8 (1.8%) 13 (3.0%) 0.83 (0.34 to 1.99) 0.67
  Target lesion 4 (0.9%) 4 (0.9%) 1.02 (0.25 to 4.06) 0.98
  Target vessel, non-target lesion 2 (0.5%) 5 (1.1%) 0.40 (0.08 to 2.08) 0.28
  Non-target vessel 6 (1.4%) 10 (2.3%) 0.76 (0.26 to 2.18) 0.61
Stent thrombosis 3 (0.7%) 4 (0.9%) 0.76 (0.17 to 3.39) 0.72
Stroke 3 (0.7%) 3 (0.7%) 1.02 (0.21to 5.03) 0.99
Bleeding: 3 (0.7%) 5 (1.1%) 0.61 (0.15 to 2.53) 0.49
  Thrombolysis in myocardial infarction major 1 (0.2%) 2 (0.5%) 0.51 (0.05 to 5.57) 0.58
  BARC type 3 2 (0.5%) 4 (0.9%) 0.50 (0.09 to 2.75) 0.43
Target lesion failure 5 (1.2%) 8 (1.8%) 0.63 (0.21 to 1.93) 0.42
Hospital stay: 33 (7.6%) 38 (8.7%) 0.92 (0.58 to 1.48) 0.74
  Cardiac 26 (6.0%) 33 (7.6%) 0.84 (0.50 to 1.42) 0.52
  Chest pain 11 (2.5%) 13 (3.0%) 0.93 (0.41 to 2.10) 0.85
*

All cause mortality, any myocardial infarction, any revascularization, stroke, and thrombolysis in myocardial infarction major bleeding (net adverse clinical events).

All cause mortality, any myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding.

Cardiac death, target lesion revascularization, or target lesion myocardial infarction.

BARC=Bleeding Academic Research Consortium