Supplementary Materials
Benefits and Risks of Extended Duration Dual Antiplatelet Therapy
after PCI in Patients With and Without Myocardial Infarction
Robert W. Yeh, Dean J. Kereiakes, Philippe Gabriel Steg, Stephan Windecker, Michael J
Rinaldi, Anthony H. Gershlick, Donald E. Cutlip, David J. Cohen, Jean Francois Tanguay, Alice
Jacobs, Stephen D. Wiviott, Joseph M. Massaro, Adrian C. Iancu, and Laura Mauri on behalf of
the Dual Antiplatelet Therapy (DAPT) Study Investigators
Harvard Clinical Research Institute (HCRI)
1
Table 1. Stent thrombosis in all randomized patients presenting initially with acute
myocardial infarction, according to stent type.
Continued
Thienopyridine Placebo
N (%)
N (%)1
Definite or Probable Stent Thrombosis
DES
7 (0.6%)
24 (1.9%)
BMS
2 (0.4%)
8 (1.7%)
Abbreviations: BMS, bare metal stent; DES, drug-eluting stent.
Hazard Ratio
(95% CI)
P Value
for
Interaction
0.87
0.28 (0.12,0.65)
0.24 (0.05,1.14)
Table 2. Stent thrombosis in all randomized patients presenting initially without
myocardial infarction, according to stent type.
Continued
Thienopyridine Placebo
N (%)
N (%)1
Definite or Probable Stent Thrombosis
DES
BMS
12 (0.3%)
2 (0.6%)
41 (1.1%) 0.29 (0.15,0.55)
1 (0.3%) 2.04 (0.18,22.48)
Abbreviations: BMS, bare metal stent; DES, drug-eluting stent.
Harvard Clinical Research Institute (HCRI)
Hazard Ratio
(95% CI)
2
P Value
for
Interaction
0.12
Table 3. Ischemic and bleeding outcomes in all randomized patients presenting initially
with myocardial infarction, according to thienopyridine type.
Continued
Thienopyridine Placebo
N (%)
N (%)1
Definite or Probable Stent Thrombosis
Clopidogrel
Prasugrel
Myocardial Infarction
Clopidogrel
Prasugrel
GUSTO Moderate or Severe Bleeding
Clopidogrel
Prasugrel
4 (0.4%)
5 (0.9%)
13 (1.2%)
19 (3.2%)
28 (2.3%)
13 (2.2%)
48 (4.3%)
40 (6.8%)
26 (2.2%)
8 (1.4%)
7 (0.6%)
7 (1.2%)
P Value
Hazard Ratio
for
(95% CI)
Interaction
0.86
0.29 (0.10,0.90)
0.26 (0.10,0.69)
0.22
0.52 (0.32,0.83)
0.32 (0.17,0.59)
0.09
3.60 (1.56,8.29)
1.14 (0.41,3.15)
Table 4. Ischemic and bleeding outcomes in all randomized presenting initially without
myocardial infarction, according to thienopyridine type.
Continued
Thienopyridine Placebo
N (%)
N (%)1
Definite or Probable Stent Thrombosis
Clopidogrel
Prasugrel
Myocardial Infarction
Clopidogrel
Prasugrel
GUSTO Moderate or Severe Bleeding
Clopidogrel
Prasugrel
Harvard Clinical Research Institute (HCRI)
7 (0.3%)
7 (0.6%)
21 (0.8%)
21 (1.8%)
56 (2.1%)
26 (2.1%)
78 (2.9%)
57 (4.8%)
43 (1.6%)
27 (2.2%)
35 (1.3%)
12 (1.0%)
3
P Value
Hazard Ratio
for
(95% CI)
Interaction
0.97
0.33 (0.14,0.78)
0.32 (0.14,0.76)
0.10
0.72 (0.51,1.01)
0.44 (0.27,1.70)
0.13
1.23 (0.79,1.93)
2.21 (1.12,4.36)
Table 5. Ischemic and bleeding outcomes for myocardial infarction versus nonmyocardial infarction patients by treatment arm, excluding those receiving paclitaxeleluting stents.
Continued
Thienopyridine Placebo
N (%)
N (%)1
Definite or Probable Stent Thrombosis
Myocardial Infarction
No Myocardial Infarction
Myocardial Infarction
Myocardial Infarction
No Myocardial Infarction
Harvard Clinical Research Institute (HCRI)
7 (0.5%)
5 (0.2%)
14 (1.1%)
20 (0.7%)
31 (2.3%)
59 (2.0%)
53 (4.1%)
83 (2.8%)
4
P Value
Hazard Ratio
for
(95% CI)
Interaction
0.34
0.48 (0.19,1.18)
0.25 (0.10,0.67)
0.57
0.55 (0.35,0.86)
0.72 (0.51,1.00)
Table 6. Bleeding outcomes using the BARC definitions 12-30 months after coronary
stent treatment in all randomized patients, stratified by presentation with versus without
myocardial infarction.
Continued
Thienopyridine
N (%)
Placebo
N (%)
Hazard Ratio
(95% CI)
Log-Rank P Value for
P Value Interaction
BARC 2, 3 or 5
MI Group
No MI Group
0.666
76 (4.3%)
223 (5.7%)
35 (2.1%)
116 (3.0%)
2.14 (1.43,3.19)
1.93 (1.55,2.42)
<0.001
<0.001
BARC 2
MI Group
No MI Group
0.844
41 (2.3%)
126 (3.2%)
20 (1.2%)
59 (1.5%)
2.01 (1.18,3.43)
2.14 (1.57,2.91)
0.009
<0.001
BARC 3
MI Group
No MI Group
0.144
35 (2.0%)
103 (2.6%)
12 (0.7%)
62 (1.6%)
2.86 (1.48,5.50)
1.66 (1.21,2.28)
0.001
0.001
BARC 5
MI Group
No MI Group
0.548
3 (0.2%)
4 (0.1%)
Harvard Clinical Research Institute (HCRI)
3 (0.2%)
2 (0.1%)
5
0.97 (0.20,4.82)
1.99 (0.36,10.85)
0.97
0.42