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Table 2 Thirty-day outcomes of randomized clinical trials comparing an invasive treatment strategy to a delayed invasive or ischemia-guided approach among STEMI patients treated with fibrinolysis.

From: Routine invasive management after fibrinolysis in patients with ST-elevation myocardial infarction: a systematic review of randomized clinical trials

Study

Outcome

Risk in Invasive Group

(n/N)

Risk in Selective Group

(n/N)

Relative Risk

(95% CI)

p-value

PRAGUE[16]

Death/Reinfarction/Stroke*

15/100

23/99

0.65 (0.36, 1.16)

0.14‡

 

Death

12/100

14/99

0.85 (0.41, 1.74)

0.66‡

 

Reinfarction

7/100

10/99

0.69 (0.27, 1.75)

0.43‡

 

Stroke

3/100

1/99

2.97 (0.31, 28.1)

0.62‡

SIAM-3[18]†

CABG

0/82

0/81

-

1.00

 

TLR

2/82

2/81

0.99 (0.14, 6.84)‡

0.685

 

Ischemic Events

3/82

20/81

0.15 (0.05, 0.48)‡

0.01

 

Reinfarction

2/82

2/81

0.99 (0.14, 6.84)‡

0.685

 

Death

4/82

8/81

0.49 (0.15, 1.58)‡

0.179

 

Death/Reinfarction

6/82

10/81

0.59 (0.23, 1.55)‡

0.208

 

Death/Reinfarction/TLR

6/82

11/81

0.54 (0.21, 1.39)‡

0.146

 

Death/Reinfarction/TLR/Ischemic Events

7/82

25/81

0.28 (0.13, 0.60)‡

0.001

GRACIA-1[19]

Death

6/248

6/251

1.01 (0.33, 3.10)

0.84

 

Non-Fatal Reinfarction

3/248

4/251

0.76 (0.17, 3.36)

0.98

 

Death/Non-Fatal Reinfarction

9/248

9/251

1.01 (0.41, 2.51)

0.97

 

Death/Non-Fatal Reinfarction/Revascularization

12/248

16/251

0.76 (0.37, 1.57)

0.46

CAPITAL-AMI[20]

Death/Recurrent MI/Recurrent Unstable Ischemia, Stroke

8/86

18/84

0.43 (0.20, 0.93)

0.03

 

Death

2/86

3/84

0.64 (0.11, 3.75)

0.68

 

Reinfarction

4/86

11/84

0.35 (0.12, 1.06)

0.06

 

Recurrent Unstable Ischemia

6/86

15/84

0.39 (0.16, 0.95)

0.04

 

Stroke

1/86

1/84

0.97 (0.61, 15.18)

1.00

 

Death/Reinfarction/Stroke

6/86

14/84

0.41 (0.17, 1.03)

0.06

Leipzig[23]

Death

2/82

4/82

0.50 (0.09, 2.65)‡

0.68‡

 

Non-Fatal Reinfarction

3/82

7/82

0.43 (0.11, 1.60)‡

0.33‡

 

Stroke

0/82

1/82

-

1.00‡

 

Major bleeding

4/82

5/82

0.80 (0.22, 2.87)‡

1.00‡

 

Death/Reinfarction/Stroke/Major Bleeding

9/82

17/82

0.52 (0.23, 1.18)

0.13Â¥

WEST[25]

Death/Reinfarction/Refractory Ischemia/CHF/Cardiogenic Shock/Major Ventricular Arrhythmia*

25/104

25/100

0.96 (0.59, 1.56) ‡

0.87‡

 

Death

1/104

4/100

0.24 (0.03, 2.11) ‡

0.21‡

 

Reinfarction

6/104

9/100

0.64 (0.24, 1.74) ‡

0.38‡

 

CHF

15/104

15/100

0.96 (0.50, 1.86)‡

0.91‡

 

Cardiogenic Shock

4/104

6/100

0.64 (0.19, 2.20)‡

0.53‡

 

Refractory Ischemia

3/104

0/100

-

0.25‡

 

Major Ventricular Arrhythmias

1/104

1/100

0.96 (0.06, 15.2)‡

1.00‡

CARESS-AMI[26]

Death/Reinfarction/Refractory Ischemia*

13/297

32/300

0.41 (0.22, 0.77)‡

0.005

 

Death

9/297

14/300

0.65 (0.29, 1.48)‡

0.40

 

Reinfarction

4/297

6/300

0.67 (0.19, 2.36)‡

0.75

 

Refractory Ischemia

1/297

12/300

0.08 (0.01, 0.64)‡

0.003

TRANSFER AMI[27]

Death/Reinfarction/Recurrent Ischemia/New or Worsening CHF/Cardiogenic Shock*

59/536

90/522

0.64 (0.47, 0.87)

0.004

 

Death

24/536

18/522

1.30 (0.71, 2.36)

0.39

 

Reinfarction

18/536

30/522

0.57 (0.33, 1.04)

0.06

 

Death/Reinfarction

38/536

47/522

0.79 (0.52, 1.19)

0.25

 

Recurrent Ischemia

1/536

11/522

0.09 (0.01, 0.68)

0.003

 

Death/Reinfarction/Recurrent Ischemia

39/536

58/522

0.65 (0.44, 0.96)

0.03

 

New or Worsening CHF

16/536

29/522

0.54 (0.30, 0.98)

0.04

 

Cardiogenic Shock

24/536

16/522

1.46 (0.79, 2.72)

0.23

NORDISTEMI[28]

Death/Reinfarction/Stroke/New Ischemia

14/134

28/132

0.49 (0.27, 0.89)‡

0.02‡

 

Death/Reinfarction/Stroke

6/134

13/132

0.45 (0.18, 1.16)‡

0.09‡

 

Death

3/134

3/132

0.99 (0.20, 4.79)‡

1.00‡

 

Reinfarction

2/134

7/132

0.28 (0.06, 1.33)‡

0.10‡

 

Stroke

3/134

5/132

0.59 (0.14, 2.42)‡

0.50‡

 

Recurrent Ischemia

8/134

16/132

0.49 (0.22, 1.11)‡

0.08‡

  1. Abbreviations: CHF: congestive heart failure; CI: confidence interval; MI: myocardial infarction; TLR: target lesion revascularization.
  2. *Denotes primary endpoint of the trial. † Data are based on the 163 patients who met the secondary inclusion criteria rather than the 197 who were randomized. †† Data are based on the 197 patients who were randomized. ‡ Calculated using data presented in the original manuscript. ¥ Denotes p-value from log-rank test.