Table 2b. Bleeding Outcomes at 12-30 Months.

The primary safety end point was GUSTO Moderate or Severe bleeding. The one-sided test of non-inferiority (based on a delta of 0.8%) was calculated according to the Farrington-Manning approach. Only evaluable subjects were included in this analysis, e.g. subjects whose last contact date was ≥ 510 days post randomization or who experienced any adjudicated bleeding outcome at or before 540 days. The secondary analysis of BARC results by subtype are shown in Supplementary Appendix Table S5.

Bleeding Complications	Continued Thienopyridine N=4713	Placebo N=4650	Risk Difference (95% CI)	Two-sided P Value for Difference	One-sided P Value for Non-Inferiority
GUSTO Severe/Moderate	119 (2.53%)	73 (1.57%)	0.96% (0.38%, 1.53%)	0.001	0.70
GUSTO Severe	38 (0.81%)	26 (0.56%)	0.25% (-0.09%, 0.58%)	0.15
GUSTO Moderate	81 (1.72%)	48 (1.03%)	0.69% (0.22%, 1.16%)	0.004
BARC Types 2, 3, or 5	263 (5.58%)	137 (2.95%)	2.64% (1.82%, 3.45%)	<0.001
BARC Type 2	145 (3.08%)	72 (1.55%)	1.53% (0.92%, 2.14%)	<0.001
BARC Type 3	122 (2.59%)	68 (1.46%)	1.13% (0.56%, 1.70%)	<0.001
BARC Type 5	7 (0.15%)	4 (0.09%)	0.06% (-0.08%, 0.20%)	0.38

Abbreviations: BARC, Bleeding Academic Research Consortium; GUSTO, Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries.