Empiric use of anticoagulation in hospitalized patients with COVID-19: a propensity score-matched study of risks and benefits

Abstract Background Hospitalized patients with COVID-19 demonstrate a higher risk of developing thromboembolism. Anticoagulation (AC) has been proposed for high-risk patients, even without confirmed thromboembolism. However, benefits and risks of AC are not well assessed due to insufficient clinical data. We performed a retrospective analysis of outcomes from AC in a large population of COVID-19 patients. Methods We retrospectively reviewed 1189 patients hospitalized for COVID-19 between March 5 and May 15, 2020, with primary outcomes of mortality, invasive mechanical ventilation, and major bleeding. Patients who received therapeutic AC for known indications were excluded. Propensity score matching of baseline characteristics and admission parameters was performed to minimize bias between cohorts. Results The analysis cohort included 973 patients. Forty-four patients who received therapeutic AC for confirmed thromboembolic events and atrial fibrillation were excluded. After propensity score matching, 133 patients received empiric therapeutic AC while 215 received low dose prophylactic AC. Overall, there was no difference in the rate of invasive mechanical ventilation (73.7% versus 65.6%, p = 0.133) or mortality (60.2% versus 60.9%, p = 0.885). However, among patients requiring invasive mechanical ventilation, empiric therapeutic AC was an independent predictor of lower mortality (hazard ratio [HR] 0.476, 95% confidence interval [CI] 0.345–0.657, p < 0.001) with longer median survival (14 days vs 8 days, p < 0.001), but these associations were not observed in the overall cohort (p = 0.063). Additionally, no significant difference in mortality was found between patients receiving empiric therapeutic AC versus prophylactic AC in various subgroups with different D-dimer level cutoffs. Patients who received therapeutic AC showed a higher incidence of major bleeding (13.8% vs 3.9%, p < 0.001). Furthermore, patients with a HAS-BLED score of ≥2 had a higher risk of mortality (HR 1.482, 95% CI 1.110–1.980, p = 0.008), while those with a score of ≥3 had a higher risk of major bleeding (Odds ratio: 1.883, CI: 1.114–3.729, p = 0.016). Conclusion Empiric use of therapeutic AC conferred survival benefit to patients requiring invasive mechanical ventilation, but did not show benefit in non-critically ill patients hospitalized for COVID-19. Careful bleeding risk estimation should be pursued before considering escalation of AC intensity.

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Empiric use of Anticoagulation in Hospitalized Patients with COVID-19: A Propensity Score-Matched Study of Risks and Benefits

10.21203/rs.3.rs-242205/v1 ◽

2021 ◽

Author(s):

Bo Yu ◽

Victor Perez Gutierrez ◽

Alex Carlos ◽

Gregory Hoge ◽

Anjana Pillai ◽

...

Keyword(s):

Mechanical Ventilation ◽

Propensity Score ◽

Propensity Score Matching ◽

Major Bleeding ◽

Risk Estimation ◽

Large Population ◽

Invasive Mechanical Ventilation ◽

Bleeding Risk ◽

Hospitalized Patients ◽

Significant Difference

Abstract Background: Hospitalized patients with COVID-19 demonstrate a higher risk of developing thromboembolism. Anticoagulation (AC) has been proposed for high-risk patients, even without confirmed thromboembolism. However, benefits and risks of AC are not well assessed due to insufficient clinical data. We performed a retrospective analysis of outcomes from AC in a large population of COVID-19 patients. Methods: We retrospectively reviewed 1189 patients hospitalized for COVID-19 between March 15 and May 15, 2020, with primary outcomes of mortality, invasive mechanical ventilation, and major bleeding. Patients who received therapeutic AC for known indications were excluded. Propensity score matching of baseline characteristics and admission parameters was performed to minimize bias between cohorts. Results: The analysis cohort included 973 patients. Forty-four patients who received therapeutic AC for confirmed thromboembolic events and atrial fibrillation were excluded. After propensity score matching, 133 patients received empiric therapeutic AC while 215 received low dose prophylactic AC. Overall, there was no difference in the rate of invasive mechanical ventilation (73.7% versus 65.6%, p = 0.133) or mortality (60.2% versus 60.9%, p = 0.885). However, among patients requiring invasive mechanical ventilation, empiric therapeutic AC was an independent predictor of lower mortality (hazard ratio [HR] 0.476, 95% confidence interval [CI] 0.345-0.657, p < 0.001) with longer median survival (14 days vs 8 days, p < 0.001), but these associations were not observed in the overall cohort (p = 0.063). Additionally, no significant difference in mortality was found between patients receiving empiric therapeutic AC versus prophylactic AC in various subgroups with different D-dimer level cutoffs. Patients who received therapeutic AC showed a higher incidence of major bleeding (13.8% vs 3.9%, p < 0.001). Furthermore, patients with a HAS-BLED score of ≥2 had a higher risk of mortality (HR 1.482, 95% CI 1.110-1.980, p = 0.008), while those with a score of ≥3 had a higher risk of major bleeding (Odds ratio: 1.883, CI: 1.114-3.729, p = 0.016). Conclusion: Empiric use of therapeutic AC conferred survival benefit to patients requiring invasive mechanical ventilation, but did not show benefit in non-critically ill patients hospitalized for COVID-19. Careful bleeding risk estimation should be pursued before considering escalation of AC intensity.

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Corticosteroids for hospitalized patients with mild to critically-ill COVID-19: a multicenter, retrospective, propensity score-matched study

Scientific Reports ◽

10.1038/s41598-021-90246-y ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Satoshi Ikeda ◽

Toshihiro Misumi ◽

Shinyu Izumi ◽

Keita Sakamoto ◽

Naoki Nishimura ◽

...

Keyword(s):

Mechanical Ventilation ◽

Propensity Score ◽

Critically Ill ◽

Noninvasive Ventilation ◽

Clinical Status ◽

Invasive Mechanical Ventilation ◽

Hospitalized Patients ◽

Radiological Findings ◽

Corticosteroid Administration ◽

Matched Study

AbstractCorticosteroids use in coronavirus disease 2019 (COVID-19) is controversial, especially in mild to severe patients who do not require invasive/noninvasive ventilation. Moreover, many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19. In this context, this multicenter, retrospective, propensity score–matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease. This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January–April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores. The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15. Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group). The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group (OR, 0.611; 95% confidence interval [CI], 0.388–0.962; p = 0.034). The time to improvement in radiological findings was significantly shorter in the corticosteroid versus non-corticosteroid group (hazard ratio [HR], 1.758; 95% CI, 1.323–2.337; p < 0.001), regardless of baseline clinical status. The duration of invasive mechanical ventilation was shorter in corticosteroid versus non-corticosteroid group (HR, 1.466; 95% CI, 0.841–2.554; p = 0.177). Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse versus standard dose group (HR, 2.831; 95% CI, 1.347–5.950; p = 0.006). In conclusion, corticosteroids for hospitalized patients with COVID-19 did not improve clinical status on Day 15, but reduced the time to improvement in radiological findings for all patients regardless of disease severity and also reduced the duration of invasive mechanical ventilation in patients who required intubation.Trial registration: This study was registered in the University hospital Medical Information Network Clinical Trials Registry on April 21, 2020 (ID: UMIN000040211).

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Efficacy of remdesivir-containing therapy in hospitalized COVID-19 patients: a prospective clinical experience

10.1101/2021.07.01.21259852 ◽

2021 ◽

Author(s):

Alessandro Russo ◽

Erica Binetti ◽

Cristian Borrazzo ◽

Elio Gentilini Cacciola ◽

Luigi Battistini ◽

...

Keyword(s):

Mechanical Ventilation ◽

Propensity Score ◽

Propensity Score Matching ◽

Cox Regression ◽

Large Population ◽

Real Life ◽

Cox Regression Analysis ◽

Non Invasive ◽

High Flow Oxygen ◽

The Impact

Objectives: remdesivir is currently approved for the treatment of COVID-19. The recommendation for using remdesivir in COVID-19 was based on the in vitro and in vivo activity of this drug against SARS-CoV-2. Methods: this was a prospective, observational study conducted on a large population of patients hospitalized for COVID-19. The primary endpoint of the study was to evaluate the impact of remdesivir-containing therapy on 30-day mortality; secondary endpoint was the impact of remdesivir-containing therapy on the need of high flow oxygen therapy (HFNC) or non-invasive ventilation (NIV) or mechanical ventilation. Data were analyzed after propensity score matching. Results: 407 patients with SARS-CoV-2 pneumonia were consecutively enrolled. Out of these, 294 (72.2%) and 113 (27.8%) were respectively treated or not with remdesivir. Overall, 61 (14.9%) patients were treated during hospitalization with non-invasive or mechanical ventilation, while a 30-day mortality was observed in 21 (5.2%) patients. Cox regression analysis, after propensity score matching, showed that therapies, including remdesivir-containing therapy, were not statistically associated with 30-day survival or mortality, while need of HFNC/NIV (HR 17.921, CI95% 0.954-336.73, p=0.044) and mechanical ventilation (HR 3.9, CI95% 5.36-16.2, p=0.003) resulted independently associated with 30-day mortality. Finally, therapies including or not remdesivir were not independently associated with lower or higher risk of HFNC/NIV or mechanical ventilation. Conclusions: this real-life experience about the remdesivir use in hospitalized patients with COVID-19 was not associated with significant increase in rates of survival or reduced use of HFNC/NIV or mechanical ventilation, compared to patients treated with other therapies not including remdesivir.

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Efficacy of Hydroxychloroquine and Tocilizumab in Patients With COVID-19: Single-Center Retrospective Chart Review (Preprint)

10.2196/preprints.21758 ◽

2020 ◽

Author(s):

Sohaib Roomi ◽

Waqas Ullah ◽

Faizan Ahmed ◽

Soban Farooq ◽

Usama Sadiq ◽

...

Keyword(s):

Mechanical Ventilation ◽

Renal Failure ◽

Acute Renal Failure ◽

Hospital Mortality ◽

Medical Care ◽

Invasive Mechanical Ventilation ◽

Hospitalized Patients ◽

Odds Ratios ◽

Significant Difference ◽

The Impact

BACKGROUND During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial. OBJECTIVE The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. METHODS A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively. RESULTS The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates. CONCLUSIONS In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.

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Corticosteroids for hospitalized patients with mild to critically-ill COVID-19: A multicenter, retrospective, propensity score–matched study

10.21203/rs.3.rs-112443/v1 ◽

2020 ◽

Author(s):

Satoshi Ikeda ◽

Toshihiro Misumi ◽

Shinyu Izumi ◽

Keita Sakamoto ◽

Naoki Nishimura ◽

...

Keyword(s):

Mechanical Ventilation ◽

Propensity Score ◽

Critically Ill ◽

Noninvasive Ventilation ◽

Clinical Status ◽

Invasive Mechanical Ventilation ◽

Hospitalized Patients ◽

Radiological Findings ◽

Corticosteroid Administration ◽

Matched Study

Abstract Background: Corticosteroids use in coronavirus disease 2019 (COVID-19) is controversial, especially in mild to severe patients who do not require invasive/noninvasive ventilation. Moreover, many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19. In this context, this multicenter, retrospective, propensity score–matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease.Methods: This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January–April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores. The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15.Results: Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group). The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group (OR, 0.611; 95% confidence interval [CI], 0.388–0.962; p = 0.034). The time to improvement in radiological findings was significantly shorter in the corticosteroid versus non-corticosteroid group (hazard ratio [HR], 1.758; 95% CI, 1.323–2.337; p < 0.001), regardless of baseline clinical status. The duration of invasive mechanical ventilation was shorter in corticosteroid versus non-corticosteroid group (HR, 1.466; 95% CI, 0.841–2.554; p = 0.177). Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse versus standard dose group (HR, 2.831; 95% CI, 1.347–5.950; p = 0.006).Conclusions: Corticosteroids for hospitalized patients with COVID-19 did not improve clinical status on Day 15, but reduced the time to improvement in radiological findings for all patients regardless of disease severity and also reduced the duration of invasive mechanical ventilation in patients who required intubation.Trial registration: This study was registered in the University hospital Medical Information Network Clinical Trials Registry on April 21, 2020 (ID: UMIN000040211).

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Efficacy of Hydroxychloroquine and Tocilizumab in Patients With COVID-19: Single-Center Retrospective Chart Review

Journal of Medical Internet Research ◽

10.2196/21758 ◽

2020 ◽

Vol 22 (9) ◽

pp. e21758 ◽

Cited By ~ 2

Author(s):

Sohaib Roomi ◽

Waqas Ullah ◽

Faizan Ahmed ◽

Soban Farooq ◽

Usama Sadiq ◽

...

Keyword(s):

Mechanical Ventilation ◽

Renal Failure ◽

Acute Renal Failure ◽

Hospital Mortality ◽

Medical Care ◽

Invasive Mechanical Ventilation ◽

Hospitalized Patients ◽

Odds Ratios ◽

Significant Difference ◽

The Impact

Background During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial. Objective The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. Methods A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively. Results The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates. Conclusions In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.

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Chemoembolization Plus Radiotherapy versus Chemoembolization Plus Sorafenib for the Treatment of Hepatocellular Carcinoma Invading the Portal Vein: A Propensity Score Matching Analysis

Cancers ◽

10.3390/cancers12051116 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1116 ◽

Cited By ~ 1

Author(s):

Hee Ho Chu ◽

Jin Hyoung Kim ◽

Ju Hyun Shim ◽

Sang Min Yoon ◽

Pyeong Hwa Kim ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Propensity Score ◽

Portal Vein ◽

Propensity Score Matching ◽

Combined Treatment ◽

Correct Selection ◽

Advanced Hepatocellular Carcinoma ◽

Entire Study ◽

Treatment Type ◽

Significant Difference

A combination of transarterial chemoembolization (TACE) plus sorafenib or radiotherapy (RT) has demonstrated efficacy in patients with advanced hepatocellular carcinoma (HCC). Here, the two combined treatment approaches were compared in patients with HCC and portal vein tumor thrombus (PVTT). Data from 307 patients treated with TACE plus RT (n = 203) or TACE plus sorafenib (n = 104) as first-line treatment for HCC with PVTT were retrospectively evaluated. Using the propensity model to correct selection bias, 87 patients were included from each treatment group. During follow up (median, 12 months) in the entire study population, the median progression-free survival (PFS) and overall survival (OS) were significantly longer in the TACE plus RT group than in the TACE plus sorafenib group (6.5 vs. 4.3 months, respectively; p = 0.017 and 16.4 vs. 12 months, respectively; p = 0.007). Following propensity score matching, the median PFS and OS in the two groups showed no statistically significant difference. Multivariable analysis found no significant association between PFS or OS and the treatment type. In conclusion, this retrospective study of data from patients with advanced HCC with PVTT shows that PFS and OS did not differ significantly in patients treated with TACE plus RT and TACE plus sorafenib.

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Abstract 17088: In-Hospital Complications and Outcomes of Leadless Pacemaker Implantation: A Propensity-Score Matched Analysis From Nationwide Database

Circulation ◽

10.1161/circ.142.suppl_3.17088 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Moghniuddin Mohammed ◽

Amit Noheria ◽

Seth Sheldon ◽

Madhu Reddy

Keyword(s):

Propensity Score ◽

Propensity Score Matching ◽

Real World ◽

Electronic Device ◽

Artery Bypass ◽

Pacemaker Implantation ◽

Leadless Pacemaker ◽

Ventricular Lead ◽

Significant Difference ◽

Before And After

Introduction: There are no randomized controlled trials that compared the outcomes of leadless pacemaker (L-PPM) implantation with transvenous pacemaker (TV-PPM) and there is scarcity of data on real world outcomes. Methods: We queried National Inpatient Sample to identify all adult patients who had primary discharge diagnosis of conduction disorders or tachy-arrhythmias and excluded patients who had a concomitant procedure for valve replacement, coronary artery bypass grafting, ablation and/or cardiac implantable electronic device removal so that complications can be attributed to the pacemaker implantation. We included only procedures from November 2016 to December 2017 as Micra was the only available L-PPM during that period. For the comparison cohort we selected patients, during the same time period, who had a procedure code for single chamber pacemaker implantation in conjunction with right ventricular lead placement. We performed 1:1 propensity score matching and the variables used for matching are marked with asterisk in Table 1. All the codes used to identify complications has been previously validated from the Micra Post-approval registry and Coverage with Evidence Study. Results: Total of 1,305 patients for L-PPM and 13,905 patients in the TV-PPM group were included. Baseline characteristics with standardized mean difference before and after matching are shown in Table 1. Briefly, patients in L-PPM group were younger but had higher co-morbidities compared to TV-PPM group. The complications before and after matching are shown in Table 2. Conclusions: In conclusion, we found no significant difference between in-hospital complications after propensity score matching, with the exception of deep venous thrombosis. There was no difference between length of stay but cost for L-PPM was significantly higher. In this real-world analysis, we found that the leadless PPM implantation is safe in comparison to transvenous PPM.

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Comparative study between noninvasive positive pressure ventilation and invasive mechanical ventilation in patients with respiratory failure

QJM ◽

10.1093/qjmed/hcab086.039 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Mohammed N Al Shafi'i ◽

Doaa M. Kamal El-din ◽

Mohammed A. Abdulnaiem Ismaiel ◽

Hesham M Abotiba

Keyword(s):

Intensive Care Unit ◽

Mechanical Ventilation ◽

Intensive Care ◽

Respiratory Failure ◽

Acute Respiratory Failure ◽

Positive Pressure Ventilation ◽

Invasive Mechanical Ventilation ◽

Noninvasive Positive Pressure Ventilation ◽

Positive Pressure ◽

Significant Difference

Abstract Background Noninvasive positive pressure ventilation (NIPPV) has been increasingly used in the management of respiratory failure in intensive care unit (ICU). Aim of the Work is to compare the efficacy and resource consumption of NIPPMV delivered through face mask against invasive mechanical ventilation (IMV) delivered by endotracheal tube in the management of patients with acute respiratory failure (ARF). Patients and Methods This prospective randomized controlled study included 78 adults with acute respiratory failure who were admitted to the intensive care unit. The enrolled patients were randomly allocated to receive either noninvasive ventilation or conventional mechanical ventilation (CMV). Results Severity of illness, measured by the simplified acute physiologic score 3 (SAPS 3), were comparable between the two patient groups with no significant difference between them. Both study groups showed a comparable steady improvement in PaO2:FiO2 values, indicating that NIPPV is as effective as CMV in improving the oxygenation of patients with ARF. The PaCO2 and pH values gradually improved in both groups during the 48 hours of ventilation. 12 hours after ventilation, NIPPMV group showed significantly more improvement in PaCO2 and pH than the CMV group. The respiratory acidosis was corrected in the NIPPV group after 24 hours of ventilation compared with 36 hours in the CMV group. NIPPV in this study was associated with a lower frequency of complications than CMV, including ventilator acquired pneumonia (VAP), sepsis, renal failure, pulmonary embolism, and pancreatitis. However, only VAP showed a statistically significant difference. Patients who underwent NIPPV in this study had lower mortality, and lower ventilation time and length of ICU stay, compared with patients on CMV. Intubation was required for less than a third of patients who initially underwent NIV. Conclusion Based on our study findings, NIPPV appears to be a potentially effective and safe therapeutic modality for managing patients with ARF.

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Bleeding Risk in Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants and Warfarin: A Systematic Review and Meta-Analysis of Observational Studies

Blood ◽

10.1182/blood-2019-123870 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3672-3672 ◽

Cited By ~ 1

Author(s):

Yimin Pearl Wang ◽

Rohan Kehar ◽

Alla Iansavitchene ◽

Alejandro Lazo-Langner

Keyword(s):

Major Bleeding ◽

Lower Risk ◽

Observational Studies ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Factor Xa ◽

Bleeding Risk ◽

Risk Of Bleeding ◽

Significant Difference

Introduction: The standard oral anticoagulant therapy administered to non-valvular AF patients has typically been Vitamin K Antagonists (VKA) particularly warfarin. In recent years, Direct Oral Anticoagulants (DOACs) including Direct Thrombin Inhibitors (DTI) and Direct Factor Xa inhibitors (FXa inhibitors) have become an alternative to warfarin. Randomized trials comparing warfarin and DOACs showed comparable effectiveness without significant additional major bleeding risk. However, bleeding events in RCTs may differ from those in daily use due to the routine exclusion of patients with a higher risk of bleeding from many studies. We aimed to assess bleeding risk between DOACs and warfarin in AF patients in observational studies and we also sought to determine differences between patients that were experienced or naïve to oral anticoagulants. Methods: A systematic literature search was conducted in the OVID MEDLINE® and EMBASE® electronic databases. Observational studies and randomized control trials (RCT) from 1990 to January 2019 were retrieved and examined by two independent reviewers. A pooled effect hazard ratio (HR) was calculated using a random effects model using the generic inverse variance method. Subgroup analyses according to previous exposure to anticoagulants, study type, funding type and DOAC type were conducted. The primary outcome was major bleeding risk. The secondary outcome was clinically relevant non-major bleeding. All studies must have used an established or validated definition of major bleeding. Results: The initial literature search identified 3359 potentially eligible citations. After primary screening, 150 articles were eligible for full text review and there were 35 studies including 2,356,201 patients that met the inclusion criteria. Overall, patients on DOACs were less likely to experience a bleeding event compared to warfarin (HR 0.78, 95%CI 0.71, 0.85, P<0.001). The results were consistent when analyzing patients receiving DTIs or FXa inhibitors (DTI: HR 0.76, 95% CI 0.67,0.87; FXa inhibitors: HR 0.79, 95% CI 0.69,0.89). However, among patients receiving factor Xa inhibitors, there was a significant difference in the risk of bleeding according to individual drug. Among patients receiving rivaroxaban the risk of bleeding was similar to warfarin (HR 0.98, 95%CI 0.91,1.06, p=0.60) whereas in those receiving apixaban there was a 40% reduction in the risk of bleeding compared to warfarin (HR 0.60, 95%CI 0.50,0.71, p<0.001) (Figure 1). Three studies reported information according to previous anticoagulant exposure. The overall pooled hazard ratio was 0.68 (95% CI 0.55, 0.82 p<0.001) in favor of patients on DOACs. In the subgroup analysis of previous anticoagulant use, the risk of bleeding was lower for DOACs compared to warfarin in both the experienced population (HR 0.70, 95%CI 0.51, 0.96) and the naïve population (HR 0.64, 95% CI 0.47,0.87). However, heterogeneity was moderate to high among both subgroups. Conclusion: This review and meta-analysis of observational studies including over 2.3 million patients showed that overall DOACs have a lower risk of major bleeding and clinically relevant non-major bleeding compared to warfarin. Most importantly, although the pooled effect estimate did not differ between DTIs and FXa inhibitors, among patients receiving FXa inhibitors there was a significant difference between individual agents. Patients on apixaban had a significantly lower risk of bleeding compared to warfarin in contrast to patients on rivaroxaban who had a similar risk. Disclosures No relevant conflicts of interest to declare.

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