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Table 2 Exploratory endpoints

From: Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial

 

Placebo

Sildenafil

Baseline

Follow Up

p-value

Baseline

Follow up

p-value

HR (BPM)

69 (9)

68 (7)

0.49

84 (12)

85 (12)

0.58

Cardiac magnetic resonance imaging derived parameters

RV SV (mL)

68 (19)

68 (18)

0.96

57 (19)

58 (22)

0.84

CO (l/min)

4.53 (0.94)

4.54 (1.14)

0.97

4.71 (1.44)

4.76 (1.34)

0.89

RV EDV (mL)

222 (19)

222 (12)

1.00

193 (73)

184 (76)

0.05

RV ESV (mL)

152 (18)

153 (15)

0.77

135 (62)

125 (62)

0.04

RV EF (%)

32 (8)

31 (8)

0.50

31 (8)

34 (9)

0.14

MPLS (%)

− 12.3 (3.4)

− 13.1 (3.4)

0.17

− 12.9 (4.1)

− 13.1 (4.0)

0.89

Right heart catheterization derived parameters

mPCWP (mmHg)

11.1 (4.5)

12.4 (4.4)

0.02

17.0 (4.9)

15.0 (3.7)

0.14

PAPd (mmHg)

15.7 (3.2)

17.6 (2.6)

0.31

17.1 (3.1)

17.0 (6.7)

0.96

PAPs (mmHg)

47.0 (6.6)

47.4 (4.8)

0.92

47.0 (7.7)

42.9 (5.3)

0.21

mPAP (mmHg)

27.0 (2.9)

27.6 (2.4)

0.66

27.3 (3.7)

25.3 (3.4)

0.30

PVR (wood)

3.5 (1.0)

3.5 (1.4)

0.86

2.3 (1.0)

2.0 (1)

0.43

SVO2 (%)

62.6 (6.7)

64.4 (8.5)

0.29

65.9 (8.5)

65.2 (7.3)

0.67

Trans thoracic echocardiography derived parameters

RV/LV

1.10 (0.05)

1.12 (0.19)

0.39

1.12 (0.11)

1.08 (0.21)

0.47

RV FAC (%)

0.30 (0.14)

0.30 (0.11)

0.98

0.34 (0.15)

0.37 (0.14)

0.28

TAPSE (cm)

1.79 (0.44)

1.78 (0.56)

0.86

1.69 (0.36)

1.79 (0.44)

0.33

PAAT (ms)

64 (12)

54 (12)

0.02

61 (8)

64 (13)

0.40

TI (mmHg)

36 (8)

36 (10)

0.81

33 (8)

31 (3)

0.52

  1. Exploratory endpoints assesed by heartrate (HR), cardiac magnetic resonance derived paramters, right heart catheterization derived parameters and transthoracic echocardiograhy derived parameters.  RV SV right ventricular stroke volume, CO cardiac output, RV EDV right ventricular end diastolic volume, RV ESV right ventricular end systolic volume, RV EF right ventricular ejection fraction, MPLS mean peak longitudinal strain, mPCWP mean pulmonary capillary wedge pressure, PAPd diastolic pulmonary artery pressure, PAPs systolic pulmonary artery pressure, mPAP mean pulmonary artery pressure, PVR pulmonary vascular resistance, SVO2 mixed venous oxygen saturation, RV/LV right ventricular/left ventricular diameter ratio, RV FAC right ventricular fractional area change, TAPSE tricuspid annular plane systolic excursion, PAAT pulmonary artery acceleration time. TI tricuspid regurgitation gradient. Data is reported as mean ± SD