J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 9, Number 2, February 2017, pages 163-169

Efficacy and Safety of Thrombolytic Therapy in Acute Submassive Pulmonary Embolism: Follow-Up Study

Figure 1. Transthoracic 2D echocardiogram images showing RV dilatation and dysfunction along with thrombus in a patient with acute pulmonary embolism (arrow showing thrombus in short axis view).

Figure 2. Contrast-enhanced computed tomography of pulmonary vasculature showing large saddle thrombus in right pulmonary artery (red arrow).

**Table 1.** Baseline Clinical Characteristics of the Study Patients in Both Groups (n = 86)
Variables	Group I (TNK; n = 45)	Group II (placebo; n = 41)	P-value
BMI: body mass index; RR: respiratory rate; SBP: systolic blood pressure; OCP: oral contraceptive pill.
Age (years)	54.35 ± 12.1	55.12 ± 11.7	0.2
Sex (M:F)	31/14	29/12	0.4
BMI (kg/m²)	26.5 ± 4.8	27.35 ± 3.7	0.13
SBP (mm Hg)	111 ± 9.79	112.1 ± 10.02	0.2
Heart rate (beats/min)	105.2 ± 9.18	106.5 ± 8.5	0.4
RR (/min)	18.9 ± 2.67	18.95 ± 2.48	0.3
Risk factors
Smoking	13 (28%)	12 (29%)	0.32
Immobilization	11 (24%)	11 (26%)	0.22
Surgery/major trauma in 1 month	7 (16%)	6 (14%)	0.5
Diabetes mellitus	5 (11%)	4 (10%)	0.34
Dyslipidemia	5 (11%)	4 (10%)	0.6
Active malignancy	1 (2%)	1 (2.5%)	0.19
OCP/estrogen use	0 (0%)	1 (2.5%)	0.7
Presenting symptom
Dyspnea	35 (79%)	32 (78%)	0.11
Chest pain	25 (56%)	22 (53%)	0.32
Syncope	3 (7%)	2 (4.8%)	0.5
Duration of illness (days)	3.65 ± 2.25	3.3 ± 1.83	0.6

Table 1. Baseline Clinical Characteristics of the Study Patients in Both Groups (n = 86)

Variables

Group I (TNK; n = 45)

Group II (placebo; n = 41)

P-value

BMI: body mass index; RR: respiratory rate; SBP: systolic blood pressure; OCP: oral contraceptive pill.

Age (years)

54.35 ± 12.1

55.12 ± 11.7

0.2

Sex (M:F)

31/14

29/12

0.4

BMI (kg/m²)

26.5 ± 4.8

27.35 ± 3.7

0.13

SBP (mm Hg)

111 ± 9.79

112.1 ± 10.02

0.2

Heart rate (beats/min)

105.2 ± 9.18

106.5 ± 8.5

0.4

RR (/min)

18.9 ± 2.67

18.95 ± 2.48

0.3

Risk factors

Smoking

13 (28%)

12 (29%)

0.32

Immobilization

11 (24%)

11 (26%)

0.22

Surgery/major trauma in 1 month

7 (16%)

6 (14%)

0.5

Diabetes mellitus

5 (11%)

4 (10%)

0.34

Dyslipidemia

5 (11%)

4 (10%)

0.6

Active malignancy

1 (2%)

1 (2.5%)

0.19

OCP/estrogen use

0 (0%)

1 (2.5%)

0.7

Presenting symptom

Dyspnea

35 (79%)

32 (78%)

0.11

Chest pain

25 (56%)

22 (53%)

0.32

Syncope

3 (7%)

2 (4.8%)

0.5

Duration of illness (days)

3.65 ± 2.25

3.3 ± 1.83

0.6

**Table 2.** Diagnostic Workup and Treatment (n = 86)
Variables	Group I (TNK; n = 45)	Group II (placebo; n = 41)	P-value
O₂: oxygen; RV: right ventricle; LV: left ventricle; PASP: pulmonary artery systolic pressure; UFH: unfractionated heparin.
O₂ treatment given	36 (80%)	30 (75%)	0.06
RV/LV size ratio	1.14 ± 0.11	1.16 ± 0.14	0.08
Troponin T elevation	34 (75%)	28 (70%)	0.2
Troponin I elevation	25 (55%)	26 (65%)	0.4
Either TropT/tropelevation	45 (100%)	41 (100%)	0.5
Baseline mean PASP, mm Hg	48.90 ± 3.0	49.21 ± 3.09	0.6
UFH given before randomization	11 (25%)	14 (35%)	0.2

Table 2. Diagnostic Workup and Treatment (n = 86)

Variables

Group I (TNK; n = 45)

Group II (placebo; n = 41)

P-value

O₂: oxygen; RV: right ventricle; LV: left ventricle; PASP: pulmonary artery systolic pressure; UFH: unfractionated heparin.

O₂ treatment given

36 (80%)

30 (75%)

0.06

RV/LV size ratio

1.14 ± 0.11

1.16 ± 0.14

0.08

Troponin T elevation

34 (75%)

28 (70%)

0.2

Troponin I elevation

25 (55%)

26 (65%)

0.4

Either TropT/tropelevation

45 (100%)

41 (100%)

0.5

Baseline mean PASP, mm Hg

48.90 ± 3.0

49.21 ± 3.09

0.6

UFH given before randomization

11 (25%)

14 (35%)

0.2

**Table 3.** Efficacy and Safety End Points (n = 86)
Variables	Group I (TNK; n = 45)	Group II (placebo; n = 41)	P-value
PE: pulmonary embolism; PASP: pulmonary artery systolic pressure; RV: right ventricle.
Primary composite outcome within 7 days	2 (4.5%)	8 (20%)	0.04
Secondary end points
All cause death	2 (4.5%)	2 (5%)	0.3
Hemodynamic decompensation	2 (4.5%)	8 (20%)	0.04
Recurrent PE within 7 days	2 (4.5%)	1 (2%)	0.3
Rehospitalization within 30 days	2 (4.5%)	4 (10%)	0.29
Death within 30 days	2 (4.5%)	2 (5%)	0.18
Others
Mean PASP at D7 (mm Hg)	32.80 ± 4.02	38.13 ± 4.49	0.04
Mean ↓ in PASP from baseline (mm Hg)	14.10 ± 3.95	11.08 ± 4.23	0.003
Improvement in RV function	31 (70%)	16 (40%)	0.001
Need for mechanical ventilation	2 (4.5%)	2 (5%)	0.6
Mean hospital stay (days)	8.1 ± 2.51	11.1 ± 2.14	0.001
Safety end points (bleeding within D7)
Major bleeding	1 (2%)	1 (2%)	0.45
Minor Bleeding	7 (16%)	5 (12%)	0.04
Hemorrhagic stroke	1 (2%)	0 (0%)	0

Table 3. Efficacy and Safety End Points (n = 86)

Variables

Group I (TNK; n = 45)

Group II (placebo; n = 41)

P-value

PE: pulmonary embolism; PASP: pulmonary artery systolic pressure; RV: right ventricle.

Primary composite outcome within 7 days

2 (4.5%)

8 (20%)

0.04

Secondary end points

All cause death

2 (4.5%)

2 (5%)

0.3

Hemodynamic decompensation

2 (4.5%)

8 (20%)

0.04

Recurrent PE within 7 days

2 (4.5%)

1 (2%)

0.3

Rehospitalization within 30 days

2 (4.5%)

4 (10%)

0.29

Death within 30 days

2 (4.5%)

2 (5%)

0.18

Others

Mean PASP at D7 (mm Hg)

32.80 ± 4.02

38.13 ± 4.49

0.04

Mean ↓ in PASP from baseline (mm Hg)

14.10 ± 3.95

11.08 ± 4.23

0.003

Improvement in RV function

31 (70%)

16 (40%)

0.001

Need for mechanical ventilation

2 (4.5%)

2 (5%)

0.6

Mean hospital stay (days)

8.1 ± 2.51

11.1 ± 2.14

0.001

Safety end points (bleeding within D7)

Major bleeding

1 (2%)

0.45

Minor Bleeding

7 (16%)

5 (12%)

0.04

Hemorrhagic stroke

1 (2%)

0 (0%)