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Table 2 Variables within follow-up period and clinical outcomes

From: Baseline factors identified for the prediction of good responders in patients with end-stage diffuse coronary artery disease undergoing intracoronary CD34+ cell therapy

Variable

All (N = 65)

Responder (N = 30)

Non-responder (N = 35)

P value

Post-GCSF biomarkers

 Leukocyte count, 1000/μL

42.29 ± 10.76

39.49 ± 10.34

44.69 ± 10.67

0.051

 Hematopoietic progenitor cell, μL

49.78 ± 46.68

37.00 ± 29.01

59.56 ± 55.05

0.105

 Young cell, %

7.21 ± 5.06

7.10 ± 4.93

7.30 ± 5.23

0.859

 Segment, %

77.14 ± 7.86

76.86 ± 7.60

77.39 ± 8.18

0.790

 Neutrophil count, 1000/μL

32.76 ± 9.31

30.66 ± 9.44

34.56 ± 8.94

0.093

 Flow data: stem cell, %

0.35 ± 0.24

0.30 ± 0.18

0.40 ± 0.28

0.226

 Performance CV, %

4.68 ± 2.67

4.46 ± 2.71

4.87 ± 2.65

0.540

 CD34+ cell, 1000/μL

1.27 ± 0.90

0.87 ± 0.50

1.49 ± 1.00

0.076

 CD45+ cell, 1000/μL

343.05 ± 100.35

297.66 ± 103.38

366.74 ± 92.24

0.082

 Troponin-I after cell therapy

1.24 ± 3.30

1.02 ± 2.64

1.42 ± 3.78

0.430

Clinical presentation

 CCS angina score at baseline

2.55 ± 0.75

2.27 ± 0.64

2.80 ± 0.58

0.003

 CCS angina score ≥ 3, n (%)

36 (55.4%)

11 (36.7%)

25 (71.4%)

0.005

 CCS angina score at 3 months

0.57 ± 0.77

0.33 ± 0.55

0.77 ± 0.88

0.021

 CCS angina score at 6 months

0.50 ± 0.74

0.38 ± 0.62

0.60 ± 0.66

0.282

 CCS angina score at 12 months

0.33 ± 0.57

0.17 ± 0.47

0.47 ± 0.62

0.021

 NYHA Fc of dyspnea at baseline

1.71 ± 1.13

1.43 ± 1.17

1.94 ± 1.06

0.086

 NYHA Fc of dyspnea at 3 months

0.71 ± 0.88

0.37 ± 0.62

1.00 ± 0.97

0.003

 NYHA Fc of dyspnea at 6 months

0.53 ± 0.87

0.17 ± 0.47

0.83 ± 1.01

0.001

 NYHA Fc of dyspnea at 12 months

0.54 ± 0.90

0.21 ± 0.56

0.82 ± 1.03

0.002

Examination

 Endothelial dysfunction*, n (%)

38 (64.4%)

15 (57.7%)

23 (69.7%)

0.339

 CPET METs at baseline

5.08 ± 1.17

4.83 ± 1.19

5.24 ± 1.16

0.255

 CPET METs at 6 months

5.33 ± 1.44

5.22 ± 1.44

5.38 ± 1.46

0.750

 Difference of METs 6 months vs. baseline

0.17 ± 1.20

0.47 ± 0.86

0.01 ± 1.33

0.252

 CMR LVEF at baseline, %

50.31 ± 14.52

52.69 ± 13.28

48.21 ± 15.42

0.214

 CMR LVEF at 6 months, %

52.93 ± 14.08

56.25 ± 12.33

50.03 ± 15.05

0.098

 Difference of LVEF6 months vs. baseline

2.02 ± 4.96

2.71 ± 3.87

1.41 ± 5.74

0.312

 Angiogenesis score at baseline

1.57 ± 0.63

1.73 ± 0.57

1.43 ± 0.66

0.048

 Angiogenesis score ≥ 2, n (%)

36 (56.3%)

20 (66.7%)

16 (47.1%)

0.115

 Angiogenesis score at 9 months

2.60 ± 0.83

2.65 ± 0.70

2.56 ± 0.94

0.955

 3D echo LVEF at baseline, %

51.30 ± 10.62

49.41 ± 10.38

52.91 ± 10.71

0.188

 3D echo LVEF ≥ 50%, n (%)

40 (61.5%)

17 (56.7%)

23 (65.7%)

0.455

 3D echo LVEF ≤ 40%, n (%)

9 (13.8%)

6 (20.0%)

3 (8.6%)

0.282

 3D echo LVEF at 3 months, %

55.01 ± 11.46

56.18 ± 11.36

54.11 ± 11.63

0.494

 Difference of 3D LVEF3 months vs. baseline

3.24 ± 5.91

5.71 ± 5.60

1.35 ± 5.49

0.002

 3D echo LVEF at 6 months, %

56.45 ± 12.56

57.40 ± 13.74

55.67 ± 11.64

0.359

 Difference of 3D LVEF6 months vs. baseline

4.89 ± 7.94

7.47 ± 10.06

2.76 ± 4.80

< 0.001

Baseline echocardiography

 LA diameter, mm

42.17 ± 5.39

42.70 ± 4.94

41.71 ± 5.79

0.369

 LVEDD, mm

53.25 ± 8.42

53.22 ± 8.37

53.27 ± 8.59

0.981

 2D echo LVEF, %

54.32 ± 13.03

53.85 ± 13.82

54.72 ± 12.51

0.790

Grade 2 or 3 diast. dysfxn, n (%)

26 (40.6%)

7 (23.3%)

19 (55.9%)

0.008

 TVPG, mmHg

18.32 ± 11.66

19.52 ± 13.16

17.31 ± 10.33

0.568

 Moderate to severe MR, n (%)

9 (13.8%)

5 (16.7%)

4 (11.4%)

0.722

 3D echo LVEDV, mm3

87.11 ± 27.14

86.60 ± 26.43

87.51 ± 28.08

0.896

 Systolic dyssynchrony index, %

7.75 ± 7.25

8.48 ± 8.81

7.10 ± 5.54

0.850

Outcome at 1 year

 Composite endpoints, n (%)

31 (47.7%)

14 (46.7%)

17 (48.6%)

0.878

 All-cause mortality, n (%)

10 (15.4%)

4 (13.3%)

6 (17.1%)

0.742

 Cardiovascular death, n (%)

1 (1.5%)

1 (3.3%)

0 (0.0%)

0.462

 Acute myocardial infarction, n (%)

3 (4.6%)

1 (3.3%)

2 (5.7%)

1.000

 Hospitalization for HF, n (%)

13 (20.0%)

6 (20.0%)

7 (20.0%)

1.000

 Revascularization, n (%)

16 (24.6%)

9 (30.0%)

7 (20.0%)

0.351

 Sepsis, n (%)

6 (12.3%)

2 (6.7%)

6 (17.1%)

0.270

  1. Notes: Responder was defined as 1-year improvement of LVEF ≥ 7.0% after cell-based therapy for EnD-CAD. Data are expressed as mean ± standard deviation or number (percentage)
  2. Abbreviation: GCSF granulocyte-colony stimulating factor, CV coefficient of variability, CCS Canadian Cardiovascular Society, NYHA Fc New York Heart Association functional classification, CPET cardiopulmonary exercise testing, MET metabolic equivalent of task, CMR cardiovascular magnetic resonance imaging, LVEF left ventricular ejection fraction, 3D echo three-dimensional echocardiography, 2D echo two-dimensional echocardiography, LA left atrium, LVEDD left ventricular end-diastolic diameter, diast. dysfxn diastolic dysfunction, TVPG trans-tricuspid valve pressure gradient, MR mitral regurgitation, LVEDV left ventricular end-diastolic volume, HF heart failure
  3. *Endothelial dysfunction was defined as post-nitroglycerin flow-mediated dilatation of brachial artery < 300%
  4. Composite endpoints were comprised of all-cause mortality, major adverse cardiac or cerebrovascular events (defined as cardiovascular death, acute myocardial infarction, or stroke), hospitalization for heart failure, or unexpected revascularization