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European Journal of Cardio-thoracic... Oct 2023Literature is scarce on the management of patients using direct oral anticoagulants (DOACs) undergoing elective, urgent and emergency surgery. Therefore, we summarize... (Review)
Review
OBJECTIVES
Literature is scarce on the management of patients using direct oral anticoagulants (DOACs) undergoing elective, urgent and emergency surgery. Therefore, we summarize the current evidence and provide literature-based recommendations for the management of patients on DOACs in the perioperative phase.
METHODS
A general literature review was conducted on the pharmacology of DOACs and for recommendations on the management of cardiac surgical patients on DOACs. Additionally, we performed a systematic review for studies on the use of direct DOAC reversal agents in the emergency cardiac surgical setting.
RESULTS
When surgery is elective, the DOAC cessation strategy is relatively straightforward and should be adapted to the renal function. The same approach applies to urgent cases, but additional DOAC activity drug level monitoring tests may be useful. In emergency cases, idarucizumab can be safely administered to patients on dabigatran in any of the perioperative phases. However, andexanet alfa, which is not registered for perioperative use, should not be administered in the preoperative phase to reverse the effect of factor Xa inhibitors, as it may induce temporary heparin resistance. Finally, the administration of (activated) prothrombin complex concentrate may be considered in all patients on DOACs, and such concentrates are generally readily available.
CONCLUSIONS
DOACs offer several advantages over vitamin K antagonists, but care must be taken in patients undergoing cardiac surgery. Although elective and urgent cases can be managed relatively straightforwardly, the management of emergency cases requires particular attention.
Topics: Humans; Administration, Oral; Anticoagulants; Cardiac Surgical Procedures; Dabigatran; Hemorrhage; Heparin
PubMed: 37812245
DOI: 10.1093/ejcts/ezad340 -
Safety of misoprostol vs dinoprostone for induction of labor: A systematic review and meta-analysis.European Journal of Obstetrics,... Oct 2023Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key safety considerations with its use include an increased risk of uterine rupture, tachysystole and hyperstimulation of pregnant women, which could potentially lead to a non-reassuring fetal heart rate and to fetal hypoxemia. The aim of this systematic review was to assess maternal and fetal outcomes between misoprostol group (PGE1) and dinoprostone group (PGE2) STUDY DESIGN: We search on MEDLINE (PubMed), CINHAL (EBSCOhost), EMBASE, Scopus (Ovid), CENTRAL (January 1, 1998, to December 31, 2022). Patients were eligible if they presented at greater than 36 weeks gestation with an indication for induction of labor and a single live cephalic fetus. We conducted a meta-analysis of data for both primary (cesarean section rate, instrumental deliveries rate, tachysystole, uterine rupture, post-partum haemorrage; chorionamiositis) and secondary outcomes (Apgar at 5 min <7, meconium-stained liquor, NICU admission, infant death) using odds-ratio (OR) as a measure of effect-size. Risk of bias assessment was performed with RoB-I. We performed statistical analyses using Cochrane RevMan version 5.4 software.
RESULTS
We found 39 RCTs comparing the outcomes of interest between misoprostol and dinoprostone. The pooled effect showed no statistically significant difference between the two groups in terms of cesarean section rate [OR: 0.94; 95% CI 0.84-1.05], instrumental deliveries rate [OR: 1.04; 95% CI: 0.90-1.19; p = 0.62], tachysystole [OR: 1.21; 95% CI: 0.91-1.60; p = 0.19], post-partum hemorrhage [OR: 0.85; 95% CI: 0.62-1.15p = 0.30], chorioamnionitis [OR: 0.94; 95% CI: 0.76-1.17p = 0.59], Apgar at 5 min < 7 [OR: 0.83; 95% CI: 0.61-1.12, p = 0.21], meconium-stained liquor [OR: 1.11; 95% CI: 0.97-1.27p = 0.59], NICU admission group [OR: 0.91; 95% CI: 0.77-1.09], infant death [OR: 0.57; 95% CI: 0.22-1.44]. After performing a sub-group analysis based on the type of prostaglandins administrations (oral, vaginal gel, vaginal pessary), results did not change substantially.
CONCLUSIONS
This systematic review and meta-analysis demonstrate that misoprostol and dinoprostone appear to have a similar safety profile.
Topics: Infant; Humans; Female; Pregnancy; Dinoprostone; Misoprostol; Cesarean Section; Uterine Rupture; Prostaglandins; Oxytocics; Abortifacient Agents, Nonsteroidal; Infant Death; Labor, Induced
PubMed: 37660506
DOI: 10.1016/j.ejogrb.2023.08.382 -
American Journal of Cardiovascular... Nov 2023Prevention of ischemic stroke is an essential part of managing atrial fibrillation (AF). In recent years, direct oral anticoagulants (DOACs) have emerged as an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Prevention of ischemic stroke is an essential part of managing atrial fibrillation (AF). In recent years, direct oral anticoagulants (DOACs) have emerged as an alternative to vitamin K antagonists (VKAs). Little is understood regarding the efficacy and safety of DOACs in AF patients with liver cirrhosis (LC).
OBJECTIVE
This meta-analysis is designed to evaluate the benefits and risks of DOACs compared to VKAs in AF patients with concomitant LC.
METHODS
A thorough search was conducted in PubMed, Cochrane Library, Web of Science, Embase, Scopus, and CNKI databases up to February 2023. A total of seven clinical studies including 7551 patients were analyzed in this meta-analysis. All data analyses were performed using Review Manager software version 5.3.
RESULTS
Regarding efficacy outcomes, DOACs had comparable clinical benefit in reducing ischemic stroke/systemic thromboembolism (HR=0.79, 95% CI [0.59, 1.06], p = 0.12) to VKAs. The incidence of all-cause death was similar between the DOACs and VKAs group (HR 0.94, 95% CI [0.69, 1.28], p = 0.69). Regarding safety outcomes, DOACs were associated with a significantly lower risk of major bleeding (HR 0.61, 95% CI [0.50, 0.75], p < 0.00001), intracranial hemorrhage (HR 0.55, 95% CI [0.31, 0.98], p = 0.04) and major gastrointestinal bleeding (HR 0.66, 95% CI [0.51, 0.85], p = 0.001) than VKAs. Additional subgroup analysis of advanced cirrhosis revealed that DOACs were associated with a significantly lower risk of major bleeding (HR 0.59, 95% CI [0.39, 0.89], p = 0.01) than VKAs. There were no significant differences between the DOACs and VKAs group concerning the incidence of ischemic stroke/systemic thromboembolism (HR 1.38, 95% CI [0.75, 2.55], p = 0.31) and major gastrointestinal bleeding (HR 0.65, 95% CI [0.41, 1.04], p = 0.08).
CONCLUSION
DOACs are associated with more favorable safety outcomes and may be a feasible option of oral anticoagulant for individuals with atrial fibrillation and cirrhosis. Pending validation by randomized prospective studies, the findings of this study should be interpreted with caution.
Topics: Humans; Atrial Fibrillation; Prospective Studies; Anticoagulants; Thromboembolism; Fibrinolytic Agents; Gastrointestinal Hemorrhage; Ischemic Stroke; Liver Cirrhosis; Vitamin K; Administration, Oral; Stroke
PubMed: 37639201
DOI: 10.1007/s40256-023-00598-1 -
Journal of Vascular Surgery. Venous and... Jan 2024Data on complications after upper extremity vein thrombosis (UEVT) are limited and heterogeneous. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Data on complications after upper extremity vein thrombosis (UEVT) are limited and heterogeneous.
METHODS
The aim of the present study was to evaluate the pooled proportions of venous thromboembolism (VTE) recurrence, bleeding, and post-thrombotic syndrome (PTS) in patients with UEVT. A systematic literature review was conducted of PubMed, Embase, and the Cochrane Library databases from January 2000 to April 2023 in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. All studies included patients with UEVT and were published in English. Meta-analyses of VTE recurrence, bleeding, and of PTS after UEVT were performed to compute pooled estimates and associated 95% confidence intervals (CIs). Subgroup analyses of cancer-associated UEVT and catheter-associated venous thrombosis were conducted. Patients with Paget-Schroetter syndrome or effort thrombosis were excluded.
RESULTS
A total of 55 studies with 15,694 patients were included. The pooled proportions for VTE recurrence, major bleeding, and PTS were 4.8% (95% CI, 3.8%-6.2%), 3.0% (95% CI, 2.2%-4.0%), and 23.8% (95% CI, 17.0%-32.3%), respectively. The pooled proportion of VTE recurrence was 2.7% (95% CI, 1.6%-4.6%) for patients treated with direct oral anticoagulants (DOACs), 1.7% (95% CI, 0.8%-3.7%) for patients treated with low-molecular-weight heparin (LMWH), and 4.4% (95% CI, 1.5%-11.8%) for vitamin K antagonists (VKAs; P = .36). The pooled proportion was 6.3% (95% CI, 4.3%-9.1%) for cancer patients compared with 3.1% (95% CI, 2.1%-4.6%) for patients without cancer (P = .01). The pooled proportion of major bleeding for patients treated with DOACs, LMWH, and VKAs, was 2.1% (95% CI, 0.9%-5.1%), 3.2% (95% CI, 1.4%-7.2%), and 3.4% (95% CI, 1.4%-8.4%), respectively (P = .72). The pooled proportion of PTS for patients treated with DOACs, LMWH, and VKAs was 11.8% (95% CI, 6.5%-20.6%), 27.9% (95% CI, 20.9%-36.2%), and 24.5% (95% CI, 17.6%-33.1%), respectively (P = .02).
CONCLUSIONS
The results from this study suggest that UEVT is associated with significant rates of PTS and VTE recurrence. Treatment with DOACs might be associated with lower PTS rates than treatment with other anticoagulants.
Topics: Humans; Heparin, Low-Molecular-Weight; Venous Thromboembolism; Incidence; Vitamin K; Anticoagulants; Hemorrhage; Postthrombotic Syndrome; Upper Extremity Deep Vein Thrombosis; Neoplasms; Upper Extremity
PubMed: 37717788
DOI: 10.1016/j.jvsv.2023.09.002 -
Journal of the American Heart... Apr 2024Concomitant atrial fibrillation and end-stage renal disease is common and associated with an unfavorable prognosis. Although oral anticoagulants have been well... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Concomitant atrial fibrillation and end-stage renal disease is common and associated with an unfavorable prognosis. Although oral anticoagulants have been well established to prevent thromboembolism, the applicability in patients under long-term dialysis remains debatable. The study aimed to determine the efficacy and safety of anticoagulation in the dialysis-dependent population.
METHODS AND RESULTS
An updated network meta-analysis based on MEDLINE, EMBASE, and the Cochrane Library was performed. Studies published up to December 2022 were included. Direct oral anticoagulants (DOACs, dabigatran, rivaroxaban, apixaban 2.5/5 mg twice daily), vitamin K antagonists (VKAs), and no anticoagulation were compared on safety and efficacy outcomes. The outcomes of interest were major bleeding, thromboembolism, and all-cause death. A total of 42 studies, including 3 randomized controlled trials, with 185 864 subjects were pooled. VKAs were associated with a significantly higher risk of major bleeding than either no anticoagulation (hazard ratio [HR], 1.47; 95% CI, 1.34-1.61) or DOACs (DOACs versus VKAs; HR, 0.74 [95% CI, 0.64-0.84]). For the prevention of thromboembolism, the efficacies of VKAs, DOACs, and no anticoagulation were equivalent. Nevertheless, dabigatran and rivaroxaban were associated with fewer embolic events. There were no differences in all-cause death with the administration of VKAs, DOACs, or no anticoagulation.
CONCLUSIONS
For dialysis-dependent populations, dabigatran and rivaroxaban were associated with better efficacy, while dabigatran and apixaban demonstrated better safety. No anticoagulation was a noninferior alterative, and VKAs were associated with the worst outcomes.
Topics: Humans; Atrial Fibrillation; Rivaroxaban; Dabigatran; Stroke; Network Meta-Analysis; Anticoagulants; Hemorrhage; Fibrinolytic Agents; Administration, Oral; Kidney Failure, Chronic; Thromboembolism; Randomized Controlled Trials as Topic
PubMed: 38606775
DOI: 10.1161/JAHA.123.034176 -
American Journal of Cardiovascular... Jan 2024Cangrelor is a potent intravenous non-thienopyridine P2Y12 inhibitor. We conducted a network meta-analysis to study the efficacy and safety of cangrelor as compared with... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Cangrelor is a potent intravenous non-thienopyridine P2Y12 inhibitor. We conducted a network meta-analysis to study the efficacy and safety of cangrelor as compared with the oral P2Y12 inhibition, clopidogrel, or placebo in acute coronary syndromes.
METHODS
This meta-analysis followed the Cochrane collaboration guidelines and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocols. Outcomes of interest included all-cause mortality, myocardial infarction, stent thrombosis, target vessel revascularization, major bleeding, minor bleeding, and the need for blood transfusion.
RESULTS
The analysis was comprised of 6 studies including 26,444 patients treated with cangrelor, clopidogrel, or placebo. There were no statistically significant differences in the incidence of all-cause mortality, myocardial infarction, stent thrombosis, target vessel revascularization, or major bleeding. Cangrelor was associated with a higher risk of minor bleeding than clopidogrel or placebo, with no difference in requiring blood transfusion.
CONCLUSION
Cangrelor has comparable outcomes to clopidogrel in patients with acute coronary syndromes and can be used as a reliable alternative in this population.
Topics: Humans; Clopidogrel; Acute Coronary Syndrome; Platelet Aggregation Inhibitors; Network Meta-Analysis; Purinergic P2Y Receptor Antagonists; Adenosine Monophosphate; Myocardial Infarction; Hemorrhage; Percutaneous Coronary Intervention; Treatment Outcome; Thrombosis
PubMed: 37995040
DOI: 10.1007/s40256-023-00616-2 -
World Journal of Surgical Oncology Feb 2024Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic events (VTE) remains unclear. This study aimed to investigate the efficacy and safety of DOACs versus LMWH in these patients.
MATERIALS AND METHODS
A search of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science was carried out and included all randomized controlled trials (RCTs) and observational studies that directly compared DOACs with LMWH for thromboprophylaxis in patients after cancer surgery through July 25, 2023. The primary efficacy and safety outcomes were VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB) within 30 days of surgery. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) tool for RCTs and ROBINS-I tool for non-randomized studies. This study was registered in PROSPERO (CRD42023445386).
RESULTS
We retrieved 5149articles, selected 27 for eligibility, and included 10 studies (three RCTs and seven observational studies) encompassing 3054 patients who underwent postoperative thromboprophylaxis with DOACs (41%) or LMWH (59%). Compared to LMWH thromboprophylaxis, DOACs had a comparable risk of VTE (RR:0.69[95% CI:0.46-1.02], I = 0%), major bleeding (RR:1.55 [95% CI:0.82-2.93], I = 2%), and CRNMB (RR, 0.89 [95% CI, 0.4-1.98], I = 31%) during the 30-day postoperative period. Subgroup analysis of VTE and major bleeding suggested no differences according to study type, extended thromboprophylaxis, tumor types, or different types of DOAC.
CONCLUSION
DOACs are potentially effective alternatives to LMWH for thromboprophylaxis in patients undergoing cancer surgery, without increasing the risk of major bleeding events.
Topics: Humans; Heparin, Low-Molecular-Weight; Anticoagulants; Venous Thromboembolism; Hemorrhage; Neoplasms
PubMed: 38403630
DOI: 10.1186/s12957-024-03341-5 -
Journal of Thrombosis and Thrombolysis Nov 2023The optimal initiation timing of oral anticoagulants (OACs) remains controversial in patients with atrial fibrillation (AF)-related acute ischemic stroke (AIS). The aim... (Meta-Analysis)
Meta-Analysis Review
The optimal initiation timing of oral anticoagulants (OACs) remains controversial in patients with atrial fibrillation (AF)-related acute ischemic stroke (AIS). The aim of this study is to compare the efficacy and safety of early OACs initiation with that of the delayed initiation for AIS and AF.We searched systematically the following mainstream databases: PubMed, Embase, and Web of Science from the inception to July 2023 for studies that compared the early initiation with the delayed initiation of OACs for AF-related AIS patients. Outcome measures were the incidence of hemorrhagic events, ischemic events, and combined outcomes, as well as all-cause mortality.There were 12 eligible articles included (10 cohort studies and 2 RCT), involving 11421 patients (5690 patients in the early-initiation group and 5731 in the delayed-initiation group). Meta-analysis revealed that patients receiving OACs at the early stage of stroke had a lower incidence of ischemic events (OR: 0.68; 95% CI: 0.55,0.84; p = 0.0003) and combined outcomes (OR=0.74, 95% CI (0.57,0.95), p=0.02). No significant differences were identified in the incidence of hemorrhagic events (p = 0.26) and all-cause mortality ( p = 0.20) between the groups.Early initiation of anticoagulation therapy would be preferable in lowering the incidence of ischemic events and combined outcomes in AIS patients with AF. It is safe compared to the delayed-initiation strategy. However, the conclusion of this study needs to be further validated by more well-designed RCTs.
Topics: Humans; Atrial Fibrillation; Ischemic Stroke; Administration, Oral; Stroke; Anticoagulants; Hemorrhage
PubMed: 37505339
DOI: 10.1007/s11239-023-02872-0 -
Cardiovascular Drugs and Therapy Dec 2023The purpose of this meta-analysis was to compare efficacy and safety of direct oral anticoagulants (DOACs) to warfarin for secondary stroke prevention among adult... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The purpose of this meta-analysis was to compare efficacy and safety of direct oral anticoagulants (DOACs) to warfarin for secondary stroke prevention among adult patients with atrial fibrillation and prior stroke.
METHODS
Major repositories were screened for randomized controlled trials (RCTs), RCT subgroups, and observational studies (OBSs, divided in claims and non-claims). Occurrences of ischemic stroke or transient ischemic attack, systemic embolism, all-cause mortality, intracranial hemorrhage (ICH), and major bleeding were outcomes of interest. Hazard ratios (HRs) and their confidence intervals (95%CIs) were pooled using random-effects models for each study design. Claims studies were analyzed separately from non-claims, while RCT subgroups were grouped with OBSs (non-claims) as the randomization was broken.
RESULTS
Of 8647 articles, 20 were included (one RCT, six RCT subgroups, nine claims, and four non-claims). Comparing DOACs to warfarin, pooled HRs (95%CI) were consistently in favor of DOACs although some did not reach statistical significance: for ischemic stroke, 0.84 (0.66-1.07) in claims; 0.90 (0.77-1.06) in non-claims and RCT subgroups; for systemic embolism, 0.77 (0.62-0.96) in claims; 0.86 (0.77-0.96) in non-claims and RCT subgroups; for all-cause mortality, 0.57 (0.33-0.99) in claims; 0.87 (0.79-0.96) in non-claims and RCT subgroups; for ICH, 0.72 (0.39-1.33) in claims; 0.51 (0.38-0.67) in non-claims and RCT subgroups; and for major bleeding, 0.86 (0.71-1.03) in claims; 0.90 (0.76-1.08) for non-claims and RCT subgroups.
CONCLUSION
DOACs were associated with better efficacy and safety profiles than warfarin in atrial fibrillation patients with prior stroke, more specifically a lower risk of systemic embolism, all-cause mortality, and ICH.
Topics: Humans; Warfarin; Atrial Fibrillation; Anticoagulants; Treatment Outcome; Stroke; Hemorrhage; Intracranial Hemorrhages; Embolism; Ischemic Stroke; Administration, Oral
PubMed: 35467313
DOI: 10.1007/s10557-022-07336-w -
Internal Medicine Journal Sep 2023Findings of prior studies about the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients (≥80 years of age) with atrial... (Meta-Analysis)
Meta-Analysis Review
Findings of prior studies about the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients (≥80 years of age) with atrial fibrillation (AF) are controversial. So we performed a meta-analysis to evaluate the efficacy and safety of NOACs versus vitamin K antagonists (VKAs) in patients (≥80 years of age) with AF. A systematic review of PubMed, Cochrane, Embase, Web of Science and Chinese BioMedical databases was conducted until 1 October 2022. Studies reporting the effects and safety of NOACs versus warfarin in patients (≥80 years of age) with AF were included. Two authors independently performed study selection and data extraction. Discrepancies were resolved by consensus or through an independent third reviewer. Data were synthesised according to the Preferred Reporting Items for Systematic Reviews guidelines. We identified 15 studies providing data of 70 446 participants (≥80 years of age) suffering from AF. According to the meta-analysis (odds ratio (OR) (95% confidence interval, CI)), NOACs conferred better efficacy profile than VKAs in stroke and systemic embolism (0.8 (0.73-0.88)) and all-cause mortality (0.61 (0.57-0.65)). Otherwise, NOACs conferred a better safety profile than VKAs in major bleeding (0.76 (0.70-0.83)) and intracranial haemorrhage (ICH; 0.57 (0.47-0.68)). In conclusion, for patients (≥80 years of age) with AF, the risks of stroke and systemic embolism, all-cause mortality, were lower in NOACs compared to warfarin. The risks of major bleeding and ICH were also lower in NOACs compared to warfarin. NOACs showed better efficacy and safety than warfarin.
Topics: Humans; Anticoagulants; Atrial Fibrillation; Warfarin; Administration, Oral; Hemorrhage; Stroke; Embolism
PubMed: 37178051
DOI: 10.1111/imj.16101