Outcome |
PCI Group (N = 1082} |
Medical Therapy Group (N = 1084) |
P Value |
Hazard Ratio (95% Cl) | ||
No. of Outcomes |
Estimated 4-Yr Cumuiative Event Ratę (%) |
No. of Outcomes |
Estimated 4-Yr Cumulative Event Ratę (%) | |||
Centraily adjudicated | ||||||
Primary end point |
161 |
17.2 |
140 |
15.6 |
0.20 |
1.16 (0.92-1.45) |
Death from all causes |
87 |
9.1 |
84 |
9.4 |
0.83 |
1.03 (0.77-1.40) |
Fatal and nonfatal reinfarctionf |
59 |
7.0 |
44 |
5.3 |
0.13 |
1.36 (0.92-2.00) |
Procedure-related |
6 |
1 | ||||
Not temporally related to procedurę |
53 |
43 | ||||
Nonfatal reinfarction |
57 |
6.9 |
40 |
5.0 |
0.08 |
1.44 (0.96-2.16) |
NYHA class IV heart failure:!: |
43 |
4.4 |
44 |
4.5 |
0.92 |
0.98 (0.64-1.49) |
Cardiovascular death |
58 |
6.3 |
52 |
5.0 |
0.56 |
1.12 (0.77-1.63) |
Death or nonfatal reinfarction |
139 |
14.9 |
116 |
13.2 |
0.13 |
1.21 (0.95-1.55) |
NYHA class III or IV heart failure:j: |
57 |
5.9 |
61 |
6.2 |
0.72 |
0.94 (0.65-1.34) |
Death, reinfarction, or NYHA class III or IV heart failureY |
173 |
18.2 |
153 |
16.9 |
0.24 |
1.14 (0.92-1.42) |
Stroke |
16 |
1.7 |
19 |
2.0 |
0.62 |
0.84 (0.43-1.64) |
Site-determined | ||||||
Primary end point |
170 |
18.2 |
142 |
16.2 |
0.09 |
1.22 (0.97-1.52) |
Fatal and nonfatal reinfarction |
89 |
10.1 |
66 |
8.1 |
0.05 |
1.37 (1.00-1.89) |
Procedure-related |
17 |
7 | ||||
Not temporally related to procedurę |
72 |
59 | ||||
Nonfatal reinfarction |
80 |
9.4 |
57 |
7.2 |
0.04 |
1.43 (1.02-2.00) |
NYHA class 111—1V heart failure |
61 |
6.2 |
67 |
7.0 |
0.61 |
0.91 (0.65-1.29) |
Hospitalization or treatment for any class of heart failure |
75 |
7.4 |
77 |
8.1 |
0.89 |
0.98 (0.71-1.34) |
Revascularization (PCI orCABG) ex-cluding protocol-assigned PCI§ |
170 |
18.4 |
205 |
22.0 |
0.03 |
0.81 (0.66-0.99) |
CABG |
38 |
4.3 |
40 |
4.8 |
0.81 |
0.95 (0.61-1.48) |
Repeated elevation of cardiac marker | ||||||
Within 48 hr after randomization — no./total no. (%) |
101/1012 (10.0) |
30/918 (3.3) |
<o.ooin |
P values were calculated with the use of the log-rank test for Kaplan-Meier curves through 5 years of follow-up, unless otherwise noted.
f Two of 44 patients in the medical therapy group did not have elevated serum cardiac markers but had pain and changes on electrocardiography.
t Ali patients reaching the end point of heart failure required hospitalization or admission to a short-stay unit. Data on the site-reported func-tional class of heart failure are available in the Supplementary Appendix.
In 58 patients in the PCI group, the procedurę was repeated in the infarct-related artery, in 14 of the patients at 1 week or less after the oc-currence of an adjudicated reinfarction. In 106 patients assigned to medical therapy, PCI of the infarct-related artery was performed, in 6 of the patients at 1 week or less after the occurrence of an adjudicated reinfarction.
*|The P value was calculated with the use of the chi-square test.