Effectiveness and safety of oral anticoagulants in the treatment of acute venous thromboembolism: A nationwide comparative cohort study in France

Introduction: Data from clinical trials indicate that direct oral anticoagulants (DOACs) are non-inferior and safer than conventional therapy (low-molecular weight heparin followed by a vitamin K antagonist [VKA]) for treating venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism (PE). This study compared the effectiveness and safety of DOACs and conventional therapy in a real-world setting. Materials and Methods: This observational study used French national claims data of adult, treatment-naïve patients diagnosed with VTE (majority PE) who were hospitalized and treated for VTE with a DOAC (apixaban or rivaroxaban) or VKAs during 2013–2018. Patients with active cancer were excluded. After propensity score matching for each DOAC-VKA comparison, risks of bleeding, recurrent VTE, and all-cause mortality were compared at 6 months. Cox proportional-hazards regression was used to estimate adjusted hazard ratios of the endpoints. Results: 58137 patients were included (10775 VKAs, 10440 apixaban, 36922 rivaroxaban). Propensity score-matched cohort sizes were 7503 for apixaban and 9179 for rivaroxaban. The hazard ratio (95% confidence interval) was significantly lower for apixaban than VKAs for bleeding requiring hospitalization (0.43 [0.32-0.59]), all-cause death (0.61 [0.51-0.74]), and first-recurrent VTE (0.67 [0.52-0.85]). The hazard ratio was also significantly lower for rivaroxaban than VKAs for all-cause death (0.63 [0.53-0.74]) but not for bleeding requiring hospitalization (0.86 [0.69-1.07]) or first-recurrent VTE (0.91 [0.74-1.13]). Conclusions: Apixaban was associated with superior safety and effectiveness than VKAs. All-cause mortality was lower in both DOACs than VKAs. Our results support recommendations to use DOACs over VKAs for the treatment of VTE.

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Abstract MP13: Comparative Effectiveness of Direct Oral Anticoagulants and Warfarin on Risk of Bleeding Resulting in Hospitalization Among Venous Thromboembolism Patients

Circulation ◽

10.1161/circ.137.suppl_1.mp13 ◽

2018 ◽

Vol 137 (suppl_1) ◽

Author(s):

Pamela L Lutsey ◽

Neil A Zakai ◽

Richard F MacLehose ◽

Faye L Norby ◽

Rob F Walker ◽

...

Keyword(s):

Venous Thromboembolism ◽

Comparative Effectiveness ◽

Proportional Hazards ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Final Analysis ◽

Bleeding Risk ◽

Cox Proportional Hazards ◽

Bleeding Events ◽

Risk Of Bleeding

Background: Direct oral anticoagulants (DOACs), including rivaroxaban, dabigatran, apixaban and edoxaban, have been approved as alternatives to warfarin for the primary treatment of venous thromboembolism (VTE). However, understanding of their comparative effectiveness in practice-based populations is limited. Objective: Among anticoagulant-naïve VTE patients, estimate the association of type of oral anticoagulant (OAC) with the rate of bleeding resulting in hospitalization. Methods: Patients with VTE and prescription for an OAC were identified from the US Truven Health MarketScan® Commercial and Medicare Supplemental databases for the period from 2011-2015. Hospitalization related to bleeding events (inclusive of intracranial, gastrointestinal and other) was defined using a validated algorithm. In head-to-head comparisons, initiators of a specific OAC were matched with up to 5 initiators of the comparing OAC by age, sex, and time since database enrollment. Cox proportional hazards regression was used to calculate hazard ratios (HR) and 95% confidence intervals (95%CI) for bleeding by OAC, adjusted for age, sex, and a comorbidity propensity score (created using prevalence of 20 common diagnoses and procedures). Results: The final analysis included 83,831 VTE patients who were 49.9% female and on average (standard deviation) 59.0 (16.0) years old. Of these, the initial OAC prescribed for 2,604 was apixaban, for 1,669 dabigatran, for 28,518 rivaroxaban, and for 48,514 warfarin. A total of 1,947 bleeding events occurred over an average of 13 months. Compared to new warfarin users, risk of bleeding was lower among patients initiating apixaban [HR (95%CI): 0.55 (0.36, 0.83)] and rivaroxaban [0.80 (0.72, 0.89)], but similar among new dabigatran users [0.96 (0.72, 1.27)]. In head-to-head DOAC comparisons, relative to rivaroxaban, risk of bleeding was lower among users of apixaban [0.57 (0.36, 0.89)] but similar for users of dabigatran [1.05 (0.73, 1.51)]. Due to low numbers we did not conduct analyses of edoxaban or a head-to-head comparison of dabigatran versus apixaban. Conclusion: In this practice-based population of 83,831 patients prescribed OACs for the treatment of VTE, subsequent risk of hospitalized bleeding was lowest among those prescribed apixaban, intermediate among those prescribed rivaroxaban, and highest among those prescribed warfarin and dabigatran. These data demonstrate that differences in bleeding risk exist by DOAC. While risk factors for bleeding might impact choice of warfarin versus the DOACs, the choice between DOACs may be less likely to be based on patient conditions.

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P5239Cost-effectiveness of direct oral anticoagulants for cancer-associated venous thromboembolism

European Heart Journal ◽

10.1093/eurheartj/ehz746.0212 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

J King ◽

S Bhat ◽

L J Heath ◽

C G Derington ◽

Z Yu ◽

...

Keyword(s):

Venous Thromboembolism ◽

Cost Effectiveness ◽

Relative Risk ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Cost Effective ◽

Low Molecular Weight ◽

Cost Effectiveness Ratio ◽

Major Bleed ◽

Recurrent Vte

Abstract Background Direct oral anticoagulants (DOACs) are at least as effective as low-molecular weight heparins (LMWH) at preventing recurrence after cancer-associated venous thromboembolism (CA-VTE). DOACs are also oral and far less costly, but they may confer a higher bleeding risk than LMWH. Purpose To estimate the cost-effectiveness of DOACs and LMWHs for CA-VTE. Methods We developed a health state transition model to estimate recurrent VTE, bleeding events, quality-adjusted life years (QALY), and direct healthcare costs (2018 United States dollars) associated with DOACs vs. LMWH use. The model had four states: (1) long-term anticoagulation (first 3 months after VTE), (2) extended anticoagulation (more than 3 months after VTE), (3) off anticoagulants, and (4) death. We used a United States healthcare sector perspective, 3-month cycle length, and 1-year time horizon. Event probabilities were derived from the Hokusai Cancer VTE trial and other literature. Event and medication costs were obtained from national sources. We used a threshold of less than $50,000 per QALY gained to define cost-effectiveness. Results Compared to LMWH, DOACs were less costly (mean costs: $8,477 vs. $33,917 per year) and similarly effective (mean QALY: 0.616 vs. 0.622). The incremental cost-effectiveness ratio was $4,479,374 per QALY gained with LMWH, indicating that DOACs are cost-effective (Table 1). In threshold analyses, LMWH therapy only became cost-effective when DOAC recurrent VTE risk increased to at least 72% (relative risk vs. LMWH, 6.19) or DOAC clinically relevant bleeding increased to at least 39% (relative risk vs. LMWH, 10.09). Scenarios Recurrent VTE, % Major bleed, % Mean difference DOAC − LMW ICER DOAC LMWH Relative Risk DOAC LMWH Relative Risk Cost QALY Base case 8.1 11.6 0.71 6.8 4.0 1.75 −$25,440 (−26,496, −24,274) −0.006 (−0.019, 0.008) $4,479,374 DOAC outcome rate threshold at which LMWH becomes cost-effective* Recurrent VTE 71.5 11.7 6.19 – – – −$6,064 (−7,534, −4,627) −0.121 (−0.136, −0.108) $49,886 Major Bleed – – – 38.9 4.0 10.09 −$2,192 (−3,400, −704) −0.044 (−0.056, −0.030) $49,878 DOAC = direct oral anticoagulant, ICER = incremental cost-effectiveness ratio, LMWH = low-molecular-weight heparin, VTE = venous thromboembolism. Values are mean (95% Uncertainty Interval). Uncertainty was derived from 1,000 stochastic model iterations. *Represents the minimum increased risk with DOAC that would result in LMWH achieving an ICER <$50K per QALY gained. Conclusion In this simulation study, DOACs were a cost-effective oral alternative to LMWH for the treatment of CA-VTE. For LMWH to be cost-effective, DOAC event rates needed to be far higher than what is likely to be observed in clinical practice. Acknowledgement/Funding Agency for Health Research and Quality R18HS026156

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Abstract 12901: Novel Oral Anticoagulants Are Associated With Decreased Recurrence of Venous Thromboembolism in Patients With Cancer: An Updated Meta-Analysis

Circulation ◽

10.1161/circ.142.suppl_3.12901 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Sunil Upadhaya ◽

Seetharamprasad Madala ◽

Sunil Badami

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Novel Oral Anticoagulants ◽

P Value ◽

Patients With Cancer ◽

Randomized Controlled ◽

All Cause Mortality ◽

Recurrent Vte

Introduction: Patients with cancer are at high risk for recurrent thromboembolic phenomenon. Use of novel oral anticoagulants (NOAC) for treatment of venous thromboembolism (VTE) in such patients is controversial. We conducted this updated meta-analysis to evaluate the pooled efficacy and safety of NOAC in patients with cancer. Methods: We did systematic search of PubMed and Cochrane library databases for randomized controlled trials comparing NOAC with low molecular weight heparin (LMWH) for VTE treatment in cancer patients till April 2020. The efficacy outcomes were recurrent VTE and all-cause mortality rates, and the primary safety outcome was incidence of major bleeding rate. Results: Four randomized controlled studies comparing NOAC with LMWH (1446 patients in NOAC group and 1448 patients in LMWH group) were included in our study. Use of NOAC lead to significant reduction in recurrent VTE rate (odds ratio (OR): 0.55 [0.36-0.84], I 2 = 45 %, p value = 0.006) (Figure 1). However, we did not find any significant difference in rate of major bleeding (OR: 1.30 [0.76-2.23], I 2 = 35%, p value = 0.34) (Figure 2) and all-cause mortality (OR: 1 [0.80 - 1.26], I 2 = 33%, p value = 0.98). Conclusions: This updated meta-analysis showed comparatively lower pooled recurrent VTE rate in patient being treated with NOAC, whereas similar rates of major bleeding and all-cause death. NOAC are more efficacious and has similar safety profile compared with LMWH.

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Abstract 13950: Predicted Heart Mass and BMI: Evaluating Undersized Heart Transplantation in Obese vs. Non-Obese Patients

Circulation ◽

10.1161/circ.142.suppl_3.13950 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Samuel T Kim ◽

Mark R Helmers ◽

Peter Altshuler ◽

Amit Iyengar ◽

Jason Han ◽

...

Keyword(s):

Propensity Score ◽

Heart Transplantation ◽

Propensity Score Matching ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Hazard Ratio ◽

Obese Patients ◽

Heart Transplants ◽

Term Survival ◽

Heart Mass

Introduction: Although guidelines for heart transplant currently recommend against donors weighing ≥ 30% less than the recipient, recent studies have shown that the detriment of under-sizing may not be as severe in obese recipients. Furthermore, predicted heart mass (PHM) has been shown to be more reliable for size matching compared to metrics such as weight and body surface area. In this study, we use PHM to characterize the effects of undersized heart transplantation (UHT) in obese vs. non-obese recipients. Methods: Retrospective analysis of the UNOS database was performed for heart transplants from Jan. 1995 to Sep. 2020. Recipients were stratified by obese (BMI ≥ 30) and non-obese (30 > BMI ≥ 18.5). Undersized donors were defined as PHM ≥ 20% less than recipient PHM. Obese and non-obese populations separately underwent propensity score matching, and Kaplan-Meier estimates were used to graph survival. Multivariable Cox proportional-hazards analyses were used to adjust for confounders and estimate the hazard ratio for death attributable to under-sizing. Results: Overall, 50,722 heart transplants were included in the analysis. Propensity-score matching resulted in 2,214, and 1,011 well-matched pairs, respectively, for non-obese and obese populations. UHT in non-obese recipients resulted in similar 30-day mortality (5.7% vs. 6.3%, p = 0.38), but worse 15-year survival (38% vs. 35%, P = 0.04). In contrast, obese recipients with UHT saw similar 30-day mortality (6.4% vs. 5.5%, p = 0.45) and slightly increased 15-year survival (31% vs. 35%, P = 0.04). Multivariate Cox analysis showed that UHT resulted in an adjusted hazard ratio of 1.08 (95% CI 1.01 - 1.16) in non-obese recipients, and 0.87 (95% CI 0.78 - 0.98) in obese recipients. Conclusions: Non-obese patients with UHT saw worse long-term survival, while obese patients with UHT saw slightly increased survival. These findings may warrant reevaluation of the current size criteria for obese patients awaiting a heart.

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Comparative clinical outcomes between direct oral anticoagulants and warfarin among elderly patients with non-valvular atrial fibrillation in the CMS medicare population

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-019-01838-5 ◽

2019 ◽

Vol 48 (2) ◽

pp. 240-249 ◽

Cited By ~ 2

Author(s):

Alpesh Amin ◽

Allison Keshishian ◽

Oluwaseyi Dina ◽

Amol Dhamane ◽

Anagha Nadkarni ◽

...

Keyword(s):

Atrial Fibrillation ◽

Lower Risk ◽

Proportional Hazards ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Cox Proportional Hazards ◽

Cardiac Events ◽

Cox Proportional Hazards Models ◽

Medicare Patients ◽

Similar Risk

AbstractAtrial fibrillation (AF) prevalence increases with age; > 80% of US adults with AF are aged ≥ 65 years. Compare the risk of stroke/systemic embolism (SE), major bleeding (MB), net clinical outcome (NCO), and major adverse cardiac events (MACE) among elderly non-valvular AF (NVAF) Medicare patients prescribed direct oral anticoagulants (DOACs) vs warfarin. NVAF patients aged ≥ 65 years who initiated DOACs (apixaban, dabigatran, and rivaroxaban) or warfarin were selected from 01JAN2013-31DEC2015 in CMS Medicare data. Propensity score matching was used to balance DOAC and warfarin cohorts. Cox proportional hazards models estimated the risk of stroke/SE, MB, NCO, and MACE. 37,525 apixaban–warfarin, 18,131 dabigatran–warfarin, and 55,359 rivaroxaban–warfarin pairs were included. Compared to warfarin, apixaban (HR: 0.69; 95% CI 0.59–0.81) and rivaroxaban (HR: 0.82; 95% CI 0.73–0.91) had lower risk of stroke/SE, and dabigatran (HR: 0.88; 95% CI 0.72–1.07) had similar risk of stroke/SE. Apixaban (MB: HR: 0.61; 95% CI 0.57–0.67; NCO: HR: 0.64; 95% CI 0.60–0.69) and dabigatran (MB: HR: 0.79; 95% CI 0.71–0.89; NCO: HR: 0.84; 95% CI 0.76–0.93) had lower risk of MB and NCO, and rivaroxaban had higher risk of MB (HR: 1.08; 95% CI 1.02–1.14) and similar risk of NCO (HR: 1.04; 95% CI 0.99–1.09). Compared to warfarin, apixaban had a lower risk for stroke/SE, MB, and NCO; dabigatran had a lower risk of MB and NCO; and rivaroxaban had a lower risk of stroke/SE but higher risk of MB. All DOACs had lower risk of MACE compared to warfarin.

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Dose reduction of edoxaban preserves efficacy and safety for the treatment of venous thromboembolism

Thrombosis and Haemostasis ◽

10.1160/th16-03-0244 ◽

2016 ◽

Vol 116 (10) ◽

pp. 747-753 ◽

Cited By ~ 11

Author(s):

Philip S. Wells ◽

Annelise Segers ◽

Walter Ageno ◽

Marjolein P. A. Brekelmans ◽

Alexander T. Cohen ◽

...

Keyword(s):

Body Weight ◽

Venous Thromboembolism ◽

Dose Reduction ◽

Drug Exposure ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Efficacy And Safety ◽

P Glycoprotein ◽

Recurrent Vte ◽

Glycoprotein Inhibitors

SummaryDirect oral anticoagulants simplify venous thromboembolism (VTE) treatment by obviating the need for coagulation monitoring. Nonetheless, renal function, body weight and P-glycoprotein inhibitors influence drug levels. The objective of this analysis was to determine whether reduction in edoxaban dose based on clinical criteria avoids excess drug exposure and preserves efficacy and safety in the Hokusai-VTE study. After initial heparin, patients received edoxaban or warfarin for 3-12 months. Edoxaban was given once daily at a dose of 60 mg, which was reduced to 30 mg in patients with a creatinine clearance of 30–50 ml/minute, body weight ≤60 kg or receiving certain P-glycoprotein inhibitors. The primary efficacy outcome was recurrent VTE and the principal safety outcome was major or clinically relevant non-major bleeding. A total of 8292 patients with acute VTE were randomised, 733 and 719 patients in the edoxaban and warfarin groups met the criteria for dose reduction. These patients were older, more often female or Asian and had more extensive VTE. Edoxaban levels were lower in the 30 mg edoxaban group. Rates of recurrent VTE and bleeding with the 30 mg and 60 mg edoxaban dose were comparable: VTE rates were 3.0 % and 3.2 % and clinically relevant bleeding rates were 7.9 % and 8.6 %, respectively. Rates of recurrent VTE and bleeding in the warfarin-treated patients meeting the criteria for dose reduction were 4.2 % and 12.8 %, respectively. The reduced dose edoxaban regimen maintained efficacy and safety compared with the 60 mg dose but was safer than warfarin in patients meeting the criteria for dose reduction.Supplementary Material to this article is available online at www.thrombosis-online.com.

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Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study

Thrombosis and Haemostasis ◽

10.1160/th17-05-0523 ◽

2017 ◽

Vol 117 (12) ◽

pp. 2406-2414 ◽

Cited By ~ 2

Author(s):

Andria Medina ◽

Gary Raskob ◽

Walter Ageno ◽

Alexander Cohen ◽

Marjolein Brekelmans ◽

...

Keyword(s):

Venous Thromboembolism ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Similar Efficacy ◽

Initial Therapy ◽

Risk Difference ◽

Efficacy And Safety ◽

Open Label ◽

Safety Outcome ◽

Recurrent Vte

AbstractDirect oral anticoagulants (DOACs) facilitate the outpatient treatment of venous thromboembolism (VTE). However, the pivotal trials of DOACs have not reported outcomes separately for patients managed either as outpatients or in the hospital. We performed a subgroup analysis of the Hokusai-VTE study comparing efficacy and safety of edoxaban with warfarin in 8,292 patients with acute VTE. Patients received initial therapy with open-label enoxaparin or unfractionated heparin for ≥5 days in the hospital or as an outpatient at the discretion of the treating physician. Edoxaban or warfarin was then given for 3 to 12 months. The primary efficacy outcome was the cumulative incidence of symptomatic recurrent VTE at 12 months. The principal safety outcome was the incidence of clinically relevant bleeding (composite of major or clinically relevant non-major bleeding). Of the 5,223 consecutively enrolled patients with recorded hospital status and length of stay, 1,414 patients (27.1%) were managed as outpatients and 3,809 were managed in hospital. Among the outpatients, initial presentation was symptomatic deep-vein thrombosis (DVT) in 1,183 patients (83.7%) and pulmonary embolism (PE) in 231 patients (16.3%). Among the outpatients with DVT, recurrent VTE occurred in 18 (3.0%) given edoxaban and in 21 (3.6%) given warfarin (risk difference: −0.61, 95% confidence interval [CI]: −2.6 to 1.4). The principal safety outcome in outpatients occurred in 46 edoxaban patients (7.7%) and in 48 warfarin patients (8.3%; risk difference: −0.59, 95% CI: −3.7 to 2.5). Most outpatients had symptomatic DVT at presentation. In these patients, initial heparin followed by edoxaban had similar efficacy and safety to standard therapy with heparin and warfarin.

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The Association between Homocysteinemia and Mortality in Pre-dialysis CKD patients: A Propensity-Score Matched Analysis Using NHANES-National Death Index Link

10.21203/rs.3.rs-948936/v1 ◽

2021 ◽

Author(s):

Je Hun Song ◽

Hyuk Huh ◽

Eunjin Bae ◽

Jeonghwan Lee ◽

Jung Pyo Lee ◽

...

Keyword(s):

Risk Factor ◽

Propensity Score ◽

Proportional Hazards ◽

Cox Regression ◽

Cox Proportional Hazards ◽

Mortality Data ◽

Protein Energy Wasting ◽

Cox Regression Analysis ◽

Cox Proportional Hazards Models ◽

All Cause Mortality

Abstract Background: Hyperhomocysteinemia (HHcy) is considered a risk factor for cardiovascular disease (CVD) including chronic kidney disease (CKD). In this study, we investigated the association between serum homocysteine (Hcy) level and mortality according to the presence of CKD.Methods: Our study included data of 9,895 participants from the 1996–2016 National Health and Nutrition Examination Surveys (NHANES). Moreover, linked mortality data were included and classified into four groups according to the Hcy level. Multivariable-adjusted Cox proportional hazards models using propensity-score were used to examine dose-response associations between Hcy level and mortality.Results: Of 9,895 participants, 1032 (21.2%) participants were diagnosed with CKD. In a multivariate Cox regression analysis including all participants, Hcy level was associated with all-cause mortality, compared with the 1st quartile in Model 3 (2nd quartile: hazard ratio (HR) 1.751, 95% confidence interval (CI) 1.348-2.274, p<0.001; 3rd quartile: HR 2.220, 95% CI 1.726-2.855, p<0.001; 4th quartile: HR 3.776, 95% CI 2.952-4.830, p<0.001). In the non-CKD group, there was a significant association with all-cause mortality; however, this finding was not observed in the CKD group. The observed pattern was similar after propensity score matching. In the non-CKD group, overall mortality increased in proportion to Hcy concentration (2nd quartile: HR 2.195, 95% CI 1.299-3.709, p = 0.003; 3rd quartile: HR 2.607, 95% CI 1.570-4.332, p<0.001; 4th quartile: HR 3.720, 95% CI 2.254-6.139, p<0.001). However, the risk of all-cause mortality according to the quartile of Hcy level did not increase in the CKD groupConclusion: This study found a correlation between the Hcy level and mortality rate only in the non-CKD group. This altered risk factor patterns may be attributed to protein-energy wasting or chronic inflammation status that is accompanied by CKD.

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286 Incidence of pocket haematoma with different anticoagulation strategies in patients undergoing cardiac implantable device implant or revision

European Heart Journal Supplements ◽

10.1093/eurheartj/suab127.044 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Enrico Guido Spinoni ◽

Matteo Santagostino ◽

Simona Costantino ◽

Eleonora Battistini ◽

Gabriele Dell’Era ◽

...

Keyword(s):

Atrial Fibrillation ◽

Multivariate Analysis ◽

Propensity Score ◽

Electronic Device ◽

Oral Anticoagulant Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Cox Proportional Hazards ◽

Bleeding Complications

Abstract Aims Direct oral anticoagulants (DOACs) are known for lower bleeding risk than vitamin K antagonist (VKA) in patients with atrial fibrillation (AF). To date, it has not been established whether in such population DOAC may offer reduction of bleeding complication in patients undergoing cardiac implantable electronic device (CIED) implant or revision (substitution, upgrade, or downgrade). We evaluated whether DOACs compared to VKAs, decrease bleeding complications at the time of CIED implant in patients with AF, requiring oral anticoagulant therapy. Methods and results We present a monocentric observational retrospective study. Patients undergoing implant, generator replacement, or upgrading/downgrading of an intracardiac device (PM, ICD, or CRT) between January 2015 and March 2021 with AF undergoing DOAC or VKA were included. The comparison of risk of clinically significant pocket hematoma at 30-days follow-up in the two-treatment group [DOAC vs. VKA and DOAC vs. VKA without low molecular weight eparin (LMWH) bridge] was performed. Cox proportional hazards regression analysis including main clinical findings was performed to test the primary endpoint. Propensity score matching analysis was performed, with inversed proportional weighted (IPW) propensity score included in the multivariate analysis. 311 patients were included, 146 (46.9%) treated with DOAC and 165 (53.1%) treated with VKA. The incidence pocket haematoma was significantly reduced in patients treated with DOAC compared with VKA (3.4% vs. 13.3%, respectively, P = 0.002), a finding confirmed on multivariate analysis (HR: 3.02, CI: 1.10–8.29, P = 0.032). The incidence of pocket haematoma in patients on DOAC vs. VKA without LMWH bridge therapy was found to be significantly higher in the latter group of patients (P = 0.033, HR: 2.93, CI: 1.01–8.49, P = 0.48). After adjusting at propensity score with IPW, DOAC use showed decreased risk of pocket haematoma (HR: 0.29, CI: 0.09–0.95, P = 0.42). Conclusions In patients with atrial fibrillation undergoing CIED implant or revision, DOAC therapy appears to be associated with lower risk of event-related pocket haematoma at 30-day follow-up, even in the absence of bridging with LWMH. Such findings are hypothesis-generating.

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Poor Prognoses of Young Hepatocellular Carcinoma Patients with Microvascular Invasion: A Propensity Score Matching Cohort Study

Gastroenterology Research and Practice ◽

10.1155/2020/4691425 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Lian Li ◽

Liangliang Xu ◽

Tianfu Wen ◽

Hong Wu ◽

Wentao Wang ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Propensity Score ◽

Propensity Score Matching ◽

Proportional Hazards ◽

Age Groups ◽

Disease Free Survival ◽

Cox Proportional Hazards ◽

Hazard Ratio ◽

Microvascular Invasion ◽

Propensity Score Matching Analysis

The relationship between age and the prognosis of patients with hepatocellular carcinoma (HCC) has been widely investigated. However, few studies have focused on the influence of patient age on the prognosis of HCC with microvascular invasion (MVI). Patients with histologically confirmed HCC with MVI who underwent hepatectomy between 2008 and 2016 were retrospectively enrolled in this study and allocated to younger (young group) and older age groups (old group) according to age< or ≥60 years. A propensity score matching analysis was performed, and prognostic factors evaluated by Kaplan–Meier curves and Cox proportional hazards regression. Intraoperative and postoperative characteristics were compared between the two groups. A total of 374 patients were enrolled in this study. There were 84 patients in each group after a 1 : 1 propensity score matching analysis. The rates of both disease-free survival (DFS) and overall survival (OS) differed significantly between the age groups. By univariate and multivariate analyses, age<60 years was significantly associated with DFS (hazard ratio, 1.590; 95% CI, 1.135–2.228) and OS (hazard ratio, 1.837; 95% CI, 1.259–2.680). There were no significant differences in intraoperative or postoperative characteristics between the two age groups. In patients with histologically confirmed HCC with MVI, the prognosis is poorer for those aged younger than 60 years than for those aged 60 years or older. Hepatectomy can be safely performed in selected older patients.

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