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Table 1 Trial and Baseline Patient Characteristics, and Interventions

From: Should dual antiplatelet therapy be used in patients following coronary artery bypass surgery? A meta-analysis of randomized controlled trials

 

Patients Randomised Post Elective CABG

Patients Randomized with ACS or symptomatic CAD - CABG Subgroup

 

Clopidogrel 300 then 75 mg/d vs placebo

Clopidogrel 75 mg/d

Clopidogrel 75 mg/d vs placebo

Clopidogrel 75 mg/d

Clopidogrel 75 mg/d

Clopidogrel 300 then 75 mg/d vs placeboa

Clopidogrel 300 then 75 mg/d vs placebo

Ticagrelor 180 then 90 mg bid vs Clopidogrel 300 then 75 mg/d

Prasugrel 60 then 10 mg/d vs Clopidogrel 300 then 75 mg/d

ASA Dose (mg/d)

325 then 81

100

162

100

300

325

75-325

75-100

75-162

Trial

Sun et al. [16]

Gao et al. [15]

CASCADE [21]

CRYSSA [22]

Gasparovic [23]

CREDO [18]

CURE [19]

PLATO [17]

TRITON- TIMI 38 [11]

n = CABG/total patients

n = 100/100

n = 249/249

n = 113/113

n = 300/300

n = 224/224

n = 83/2116

n = 2072/12562

n = 1261 (1899)/18624

n = 346 (485)/13608

Trial Characteristics

         

 No. of Centres

1

1

2

1

1

99

428

862

707

 Enrolment period

Nov 2006 – Feb 2008

Dec 2007 – Dec 2008

May 2006 – Jul 2008

Dec 2006 – Oct 2009

Jun 2010 – Feb 2013

Jun 1999 – Apr 2001

Dec 1998 – Sep 2000

Oct 2006 – Jul 2008

Nov 2004 – Jan 2007

 Treatment/Follow Up Post Randomization

30 (all)/49 (median) d

3 months (all)

12 months (all)

12 months (all)

6 months (all)

12 months (all)

9 months (mean)

224 days [7.5 months] (median)

14.5 months (median)

 Median Time to CABG Post Randomization

(Randomized At Time of CABG)

n/r (index CABG instead of PCI)

25.5 days (IQR 12–70.5)

~20 days

100 days [50]

 Treatment/Follow Up Post CABG

30 (all)/49 (median) d

3 months (all)

12 months (all)

12 months (all)

12 months (all)

~12 months (all)

~8 months (mean)

~200 days [6.7 months] (median)

~11.2 months (median)

 Funding

Public/ Industry

Public

Public/Industry

n/r

n/r

Industry

Industry

Industry

Industry

Patients

n = 99

n = 224

n = 113

n = 300

n = 219

n = 83

n = 2072

n = 1261

n = 346

 Mean Age (years)

65

59

67

59

65

61

64

64

61

 % Male

90

83

89

74

75

74

70

79

77

 BMI

31

26

28

26

29

29

 

27

n/r (28b)

 Diabetes

35 %

40 %

29 %

0 % (excl)

38 %

22 %

27 %

32 %

28 %

 Hypertension

70 %

59 %

50 %

46 %

96 %

75 %

61 %

68 %

64 %

 Smoker

59.6 % (current/ former)

55.8 % (history of)

13.2 %

n/r

36 %

33 % (within 1 year)

64.5 % (current /former)

31.2 %

n/r (38 %b)

 COPD

   

n/r

 

n/r

  

8.1 %

 Dyslipidemia

76 %

38 %

88 %

56 %

96 %

71 %

n/r

54 %

n/r (56 %b)

 Prev MI

39 %

47 %

n/r

36 %

n/r

37 %

36 %

20 %

n/r (18 %b)

 Prev stroke/TIA

5.1 %

4.9 %

n/r

n/r

n/r

n/r

3.9 %

3.9 %/3.1 %

7.8 %

 Periph Vasc Dz

5.1 %

n/r

n/r

n/r

n/r

6.2 %

9.7 %

7.6 %

7.0 %

 Chronic Renal Disease

excl Cr >130 μM

n/r

n/r

excl Cr >177 μM

n/r

n/r

n/r

4.8 %

n/r (11 % CrCl < 60 mL/minb)

 Mean LVEF

n/r

60 %

 

54 %

54 %

53 %

   

 CHF

 

0 % (excl)

20.3 %

n/r

n/r

7.3 %

 

4.1 %

10.7 %

 Severe LV dysfunction

38 %(Gr 3 LV)

0 % (excl)

n/r

n/r

n/r

n/r

Excluded

 

3.9 % (EF ≤ 30 %)

1 % (Gr 4 LV)

 Previous PCI

n/r

13 %

 

16 %

n/r

17 %

7.4 %

10 %

n/r

 Previous CABG

n/r

0 % (excl)

0 % (excl)

n/r

n/r

8.5 %

4.6 %

1.5 %

2.9 %

 3VD

54 %

  

n/r

77 %

n/r

   

 LM

24.2 %

  

n/r

48 %

n/r

   

 ST depression

      

54.2 %

  

 ST elevation

      

2.7 %

33.0 % (persistent)

 

 Abnormal ECG

      

95.2 %

  

 Diagnosis: UA

      

73.9 %

 

64.1 % (UA/NSTEMI)

 Diagnosis: MI

      

26.1 % (all NSTEMI)

 

35.9 % (STEMI)

 Abnormal  ECG/enzymes

      

97.7 %

  

CABG

         

 % Off-pump CABG

0 %

58.0 %

3.6 %

100 %

0 %

    

 % arterial conduits

100 %

100 %

100 %

100 %

93 %

    

 Grafts or adiseased vessels

4.0

3.1

3.5 ± 0.7

3.2 ± 0.6

n/r

  

1–2 (31 %)

a1 (14.4 %)

3–4 (60 %)

a2 (61.5 %)

≥5 (8 %)

a3 (20.5 %)

 Median (IQR) days to CABG (all)

      

25.5 (12–70.5)

~20

100(36)

 CABG pre-d/c

      

49 %

57 %

4.3 %

 Median (IQR) days to CABG pre-d/c

      

13 (8–21) vs 12 (8–19)

  

 CABG post-d/c

      

51 %

43 %

95.7 %

 Median (IQR) days to CABG post d/c

      

67.5 (38–141) vs 73 (36–129)

  

 Days off study drug before CABG

      

17 (9–33)

≤2d (30.1 %) 3-5d (43.8 %) >5 (26.1 %)

≤2d (25.1 %) 3-5d (29.0 %) >5 (45.4 %)

 Restarted treatment post CABG

      

76.1 % (66 never discontinued + 1451 resumed/1928; 78 data unavailable)

66.4 %

61.8 % (214/346); additional 21/173 prasugrel and 16/173 clopidogrel patients resumed open label clopidogrel

 Days off study drug after CABG

      

10 (6–25)

<7d (35.9 %)

n/r

7–14(16.8 %)

>14d (10.0 %)

  1. aIn CREDO, both groups receive clopidogrel 75 mg/day for 28 days before control group changed to placebo from day 29 through 12 months
  2. bProportion of all 13,608 randomized patients when data not provided for CABG subgroup in TRITON-TIMI 38
  3. Abbreviations: ACS acute coronary syndrome, ASA acetylsalicylic acid (aspirin), BMI body mass index, CABG coronary artery bypass grafting, CAD coronary artery disease, CHF congestive heart failure, COPD chronic obstructive pulmonary disease, d/c (hospital) discharge, DM diabetes mellitus, Dx diagnosis, Dz disease, ECG electrocardiogram, EF ejection fraction, excl excluded, incl included, IQR inter-quartile range, LM left main artery disease, LV left ventricle, mg milligram, MI myocardial infarction, mM millimolar, n number of patients, no. number, n/r not reported, PCI percutaneous coronary intervention, periph peripheral, prev previous, pts patients, Rx treatment, sd standard deviation, TIA transient ischemic attack, vasc vascular, 3VD triple vessel disease, UA unstable angina, vasc vascular