Submitted:
20 December 2023
Posted:
21 December 2023
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Abstract
Keywords:
1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Statistical Analysis
3. Results
3.1. Outcomes
3.1.1. The Primary Endpoint
3.1.2. Secondary Efficacy Endpoint
3.1.3. Mortality
3.1.4. Secondary Safety Endpoint
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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| Baseline demographics | |
|---|---|
| Female, n (%) | 58 (56,9) |
| Age,median [IQR] | 66.50 [56.00, 74.00] |
| Smoking current, n (%) past, n (%) |
8 (7.8) 15 (14.7) |
| BMI,median [IQR] | 27.50 [24.65, 30.55] |
| Hypertension, n (%) | 58 (56.9) |
| Cancer, n (%) | 29 (28.4) |
| Previous DVP, n (%) | 21 (20.6) |
| Heart faliure, n (%) | 6 (5.9) |
| CAD, n (%) | 6 (5.9) |
| Previous stroke, n (%) | 8 (7.8) |
| Previous PE, n (%) | 9 (8.8) |
| Previous DVP, n (%) | 21 (20.6) |
| Diabetes mellitus, n (%) | 13 (12.7) |
| Chronic kidney disease, n (%) | 11 (10.8) |
| Presenting symptoms | |
| Dispnea, n (%) | 75 (73,5) |
| Chest pain, n (%) | 23 (22,5) |
| Sincope, n (%) | 20 (19,6) |
| Hemoptysis, n (%) | 0 |
| Peripheral edema, n (%) | 8 (7,8) |
| Heart palpitations, n (%) | 4 (3,9) |
| Clinical presentation | |
| Systolic blood pressure, mm Hg, median [IQR] | 125 [112, 145] |
| Diastolic blood pressure, mmHg, median [IQR] | 74 [65, 85] |
| Heart rate, bpm, median [IQR] | 105 [92, 117] |
| Oxygen saturation, %, median [IQR] | 95 [93, 98] |
| First available Pao2/FiO2, median [IQR] | 252 [155, 311] |
| Sepsis, n (%) | 2 (2%) |
| Neurological alteration, n (%) | 8 (8.1%) |
| Laboratory | |
| Hemoglobin (g/dl), median [IQR] | 13.30 [11.70, 14.03] |
| Platlets (n x 10³/mm³), median [IQR] | 220 [168, 256] |
| WBC, ×103/μL,median [IQR] | 10 [8, 13] |
| D-dimer, ng/mL, median [IQR] | 12.7 [8.2, 26.7] |
| Creatinine, mg/dL, median [IQR] | 1.0 [0.8, 1.2] |
| Troponin on admission ng/L, median [IQR] | 55 [33.5, 138,5] |
| NT-proBNP, ng/L, median [IQR] | 1435.5 [481.2, 4243] |
| Arterial lactate,mmol/l, median [IQR] | 2.00 [1.39, 2.85] |
| Characteristics of PE at CT scan | |
| Bilateral main pulmonary arteries, n (%) | 77 (75,5%) |
| Unilateral main pulmunary arteries, n (%) | 7 (6,9%) |
| Bilateral, lobar, n (%) | 15 (14,7%) |
| Unilateral, lobar, n (%) | 3 (3,6%) |
| T 0 | T24 | T-FU | |
|---|---|---|---|
| TAPSE ≤16 mm (n, %) TAPSE (mm) Δ TAPSE |
56 (63%) 16 [14, 17] |
19 (19.8%) 19.5 [17, 22] 3 [1, 5] |
3 (4.5%) 23 [20, 25] 6 [4, 8] |
| PASP ≥ 40 mmHg PASP (mmHg) Δ PASP |
68 (83%) 45 [40, 55] |
29 (34%) 35 [30.5, 44] -10 [-16.25, -4] |
4 (7%) 31 [25, 35] -18 [-24, -11] |
| RV/LV > 1 RV/LV Δ RV/LV |
27 (48%) 1 [0.90, 1.10] |
15 (18%) 0.9 [0.8, 1.0] -0.10 [-0.30, -0.05] |
0 (0%) 0.8 [0.7, 0.9] -0.20 [-0.40, -0.10] |
| TAPSE/PASP Δ TAPSE/PASP |
0.32 [0.28, 0.40] | 0.54 [0.42, 0.64] 0.17 [0.09, 0.27] |
0.76 [0.64, 0.86] 0.40 [0.25, 0.52] |
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